Trial Outcomes & Findings for Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer. (NCT NCT04186819)
NCT ID: NCT04186819
Last Updated: 2025-02-26
Results Overview
The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
356 participants
Primary outcome timeframe
Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
Results posted on
2025-02-26
Participant Flow
This study was from 02 Mar 20 (first patient, screening visit) and 18 Feb 22 (database lock), with the last patient, last visit on 21 Jun 21. It was conducted at 34 activated study sites (31 recruited) in 4 countries. Of the 372 patients screened, 356 patients met all the study eligibility criteria. 16 patients were screen failures so not included
Baseline safety evaluations performed at screening (Visit 1) comprised vital signs, focused physical examination and recording of any adverse events (AEs) from the time of informed consent.
Participant milestones
| Measure |
Patients
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning
Positron Emission Tomography scan: imaging test with radioligand
|
|---|---|
|
Overall Study
STARTED
|
356
|
|
Overall Study
COMPLETED
|
336
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Patients
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning
Positron Emission Tomography scan: imaging test with radioligand
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Opted for EBRT
|
1
|
|
Overall Study
Opted SBRT
|
1
|
|
Overall Study
Patient decided to have focal ablation and not surgery
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
RP Delayed
|
1
|
|
Overall Study
Sponsor Decision: Outdated FU Timeline
|
1
|
|
Overall Study
Subject declined for financial reasons
|
1
|
|
Overall Study
The subject declined any biopsy or surgery due to COVID-19 pandemic
|
1
|
|
Overall Study
The subject declined for any biopsy or other imaging
|
2
|
|
Overall Study
The subject opted for other treatment option
|
2
|
|
Overall Study
The subject opted for other treatment options
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Reason not specified
|
1
|
Baseline Characteristics
Number analyzed differs from overall due to missing data.
Baseline characteristics by cohort
| Measure |
Single Arm
n=356 Participants
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning
Positron Emission Tomography scan: imaging test with radioligand
|
|---|---|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 6.98 • n=356 Participants
|
|
Age, Customized
< 65 years
|
163 participants
n=356 Participants
|
|
Age, Customized
≥ 65 years
|
193 participants
n=356 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=356 Participants
|
|
Sex: Female, Male
Male
|
356 Participants
n=356 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=356 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
311 Participants
n=356 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=356 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
30 participants
n=356 Participants
|
|
Race/Ethnicity, Customized
White
|
289 participants
n=356 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=356 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
33 participants
n=356 Participants
|
|
Region of Enrollment
Netherlands
|
14 participants
n=356 Participants
|
|
Region of Enrollment
United States
|
238 participants
n=356 Participants
|
|
Region of Enrollment
Finland
|
18 participants
n=356 Participants
|
|
Region of Enrollment
Germany
|
86 participants
n=356 Participants
|
|
Total Gleason Score
=7
|
160 participants
n=356 Participants
|
|
Total Gleason Score
=8
|
87 participants
n=356 Participants
|
|
Total Gleason Score
=9
|
97 participants
n=356 Participants
|
|
Total Gleason Score
=10
|
6 participants
n=356 Participants
|
|
Total Gleason Score
≤ 6
|
6 participants
n=356 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T1
|
16 participants
n=356 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T1a
|
2 participants
n=356 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T1c
|
127 participants
n=356 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T2
|
58 participants
n=356 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T2a
|
18 participants
n=356 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T2b
|
25 participants
n=356 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T2c
|
33 participants
n=356 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T3
|
20 participants
n=356 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T3a
|
21 participants
n=356 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T3b
|
12 participants
n=356 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T3c
|
1 participants
n=356 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T4
|
2 participants
n=356 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
TX
|
9 participants
n=356 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
Missing
|
12 participants
n=356 Participants
|
|
Gleason Grade Group (GGG)
=1
|
6 participants
n=356 Participants
|
|
Gleason Grade Group (GGG)
=2
|
50 participants
n=356 Participants
|
|
Gleason Grade Group (GGG)
=3
|
110 participants
n=356 Participants
|
|
Gleason Grade Group (GGG)
=4
|
87 participants
n=356 Participants
|
|
Gleason Grade Group (GGG)
=5
|
103 participants
n=356 Participants
|
|
TNM Stage M
M0
|
290 participants
n=356 Participants
|
|
TNM Stage M
M1
|
4 participants
n=356 Participants
|
|
TNM Stage M
M1a
|
1 participants
n=356 Participants
|
|
TNM Stage M
M1b
|
1 participants
n=356 Participants
|
|
TNM Stage M
MX
|
48 participants
n=356 Participants
|
|
TNM Stage M
Missing
|
12 participants
n=356 Participants
|
|
Prostate-specific antigen (PSA) Characterization (ng/mL)
>1.0 to 2.0
|
2 participants
n=356 Participants
|
|
Prostate-specific antigen (PSA) Characterization (ng/mL)
>2.0 to 5.0
|
62 participants
n=356 Participants
|
|
Prostate-specific antigen (PSA) Characterization (ng/mL)
>5.0 to 10.0
|
134 participants
n=356 Participants
|
|
Prostate-specific antigen (PSA) Characterization (ng/mL)
>10.0
|
158 participants
n=356 Participants
|
|
Baseline Risk Category
High-risk or Veryhigh-risk
|
241 participants
n=356 Participants
|
|
Baseline Risk Category
Immediate-Risk
|
115 participants
n=356 Participants
|
|
TNM Stage N
N0
|
284 participants
n=356 Participants
|
|
TNM Stage N
N1
|
11 participants
n=356 Participants
|
|
TNM Stage N
NX
|
49 participants
n=356 Participants
|
|
TNM Stage N
Missing
|
12 participants
n=356 Participants
|
|
Body Mass Index
|
28.20 Kg/m2
STANDARD_DEVIATION 4.341 • n=334 Participants • Number analyzed differs from overall due to missing data.
|
|
Time since initial cancer diagnosis
|
2.9 months
STANDARD_DEVIATION 10.27 • n=356 Participants
|
|
Time since last PSA Measurement
|
2.5 months
STANDARD_DEVIATION 2.83 • n=354 Participants • Number analyzed differs from overall due to missing data.
|
|
Last PSA Measurement (ng/mL)
|
15.090 ng/mL
STANDARD_DEVIATION 18.2450 • n=356 Participants
|
PRIMARY outcome
Timeframe: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administrationThe primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.
Outcome measures
| Measure |
Efficacy Analysis Population
n=226 Participants
All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and who underwent RP and PLND
|
Extended Efficacy Population (EEP)
M1 lesions compared to histopathology or confirmatory imaging
|
|---|---|---|
|
Specificity
Central Reader 1
|
92.9 percentage
Interval 88.8 to 95.9
|
—
|
|
Specificity
Central Reader 2
|
93.8 percentage
Interval 89.8 to 96.6
|
—
|
|
Specificity
Central Reader 3
|
96.9 percentage
Interval 93.7 to 98.7
|
—
|
PRIMARY outcome
Timeframe: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administrationThe primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.
Outcome measures
| Measure |
Efficacy Analysis Population
n=70 Participants
All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and who underwent RP and PLND
|
Extended Efficacy Population (EEP)
M1 lesions compared to histopathology or confirmatory imaging
|
|---|---|---|
|
Sensitivity
Central Reader 3
|
22.9 percentage
Interval 13.7 to 34.4
|
—
|
|
Sensitivity
Central Reader 1
|
30 percentage
Interval 19.6 to 42.1
|
—
|
|
Sensitivity
Central Reader 2
|
27.1 percentage
Interval 17.2 to 39.1
|
—
|
SECONDARY outcome
Timeframe: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET. followed by treatment within 60 days post IMP administrationThis was a key secondary endpoint in this study and included patients in the EEP with rhPSMA-7.3 (18F) imaging.
Outcome measures
| Measure |
Efficacy Analysis Population
n=352 Participants
All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and who underwent RP and PLND
|
Extended Efficacy Population (EEP)
M1 lesions compared to histopathology or confirmatory imaging
|
|---|---|---|
|
Verified Detection Rate (VDR) for M1 Lesions - Percentage of Patients in Whom rhPSMA-7.3 (18F) Imaging Detected at Least One Verified M1 Metastasis, as Determined by Central BIE and Confirmed by SoT (Biopsy or Imaging) (Objective 1)
Central Reader 1
|
9.9 percentage
Interval 7.0 to 13.6
|
—
|
|
Verified Detection Rate (VDR) for M1 Lesions - Percentage of Patients in Whom rhPSMA-7.3 (18F) Imaging Detected at Least One Verified M1 Metastasis, as Determined by Central BIE and Confirmed by SoT (Biopsy or Imaging) (Objective 1)
Central Reader 2
|
14.2 percentage
Interval 10.7 to 18.3
|
—
|
|
Verified Detection Rate (VDR) for M1 Lesions - Percentage of Patients in Whom rhPSMA-7.3 (18F) Imaging Detected at Least One Verified M1 Metastasis, as Determined by Central BIE and Confirmed by SoT (Biopsy or Imaging) (Objective 1)
Central Reader 3
|
10.2 percentage
Interval 7.3 to 13.9
|
—
|
SECONDARY outcome
Timeframe: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administrationPatients counted in this variable were a subset of those in Point 1 above, where both the numerator and denominator were only counting patients with negative conventional imaging (according to investigator assessment) for M1 disease.
Outcome measures
| Measure |
Efficacy Analysis Population
n=331 Participants
All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and who underwent RP and PLND
|
Extended Efficacy Population (EEP)
M1 lesions compared to histopathology or confirmatory imaging
|
|---|---|---|
|
Percentage of Patients With Negative Conventional Imaging for M1 Disease in Whom rhPSMA-7.3 (18F) PET Detected at Least One Verified M1 Metastasis, as Determined by Central BIE (Objective 2)
Central Reader 3
|
8.5 percentage
Interval 5.7 to 12.0
|
—
|
|
Percentage of Patients With Negative Conventional Imaging for M1 Disease in Whom rhPSMA-7.3 (18F) PET Detected at Least One Verified M1 Metastasis, as Determined by Central BIE (Objective 2)
Central Reader 1
|
8.8 percentage
Interval 5.9 to 12.3
|
—
|
|
Percentage of Patients With Negative Conventional Imaging for M1 Disease in Whom rhPSMA-7.3 (18F) PET Detected at Least One Verified M1 Metastasis, as Determined by Central BIE (Objective 2)
Central Reader 2
|
13.0 percentage
Interval 9.6 to 17.1
|
—
|
SECONDARY outcome
Timeframe: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administrationThis analysis included patients with rhPSMA-7.3 (18F) imaging and either N1 or M1 lesions detected, where PPV=TP/(TP+FP).
Outcome measures
| Measure |
Efficacy Analysis Population
n=296 Participants
All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and who underwent RP and PLND
|
Extended Efficacy Population (EEP)
n=352 Participants
M1 lesions compared to histopathology or confirmatory imaging
|
|---|---|---|
|
Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3)
Central Reader 1
|
56.8 percentage
Interval 39.5 to 72.9
|
62.5 percentage
Interval 48.5 to 75.1
|
|
Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3)
Central Reader 2
|
57.6 percentage
Interval 39.2 to 74.5
|
51.0 percentage
Interval 40.7 to 61.3
|
|
Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3)
Central Reader 3
|
69.6 percentage
Interval 47.1 to 86.8
|
57.1 percentage
Interval 44.0 to 69.5
|
SECONDARY outcome
Timeframe: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administrationThis analysis included patients in the EAP where rhPSMA-7.3 (18F) imaging detected PLN metastasis. Regions where rhPSMA7.3 (18F) imaging detected no LN metastasis were not included (by definition of PPV), hence only TP and FP regions were considered. TPs were all patients with a surgical pathology confirmed positive region and without a FP region. FP patients were those patients with any rhPSMA7.3 (18F) PETpositive region with negative or no surgical pathology.
Outcome measures
| Measure |
Efficacy Analysis Population
n=296 Participants
All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and who underwent RP and PLND
|
Extended Efficacy Population (EEP)
M1 lesions compared to histopathology or confirmatory imaging
|
|---|---|---|
|
PPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FP Patient is Defined as Having at Least One FP Region (Right or Left Pelvis), Regardless of Any Coexisting TP Findings (Objective 4)
Central Reader 1
|
48.6 percentage
Interval 31.9 to 65.6
|
—
|
|
PPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FP Patient is Defined as Having at Least One FP Region (Right or Left Pelvis), Regardless of Any Coexisting TP Findings (Objective 4)
Central Reader 2
|
54.5 percentage
Interval 36.4 to 71.9
|
—
|
|
PPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FP Patient is Defined as Having at Least One FP Region (Right or Left Pelvis), Regardless of Any Coexisting TP Findings (Objective 4)
Central Reader 3
|
65.2 percentage
Interval 42.7 to 83.6
|
—
|
SECONDARY outcome
Timeframe: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administrationThis analysis included patients in the EAP with rhPSMA-7.3 (18F) imaging where no LN metastases were detected and LN surgical pathology was available; where NPV=TN/(TN+FN).
Outcome measures
| Measure |
Efficacy Analysis Population
n=296 Participants
All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and who underwent RP and PLND
|
Extended Efficacy Population (EEP)
M1 lesions compared to histopathology or confirmatory imaging
|
|---|---|---|
|
NPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FN Patient is Defined as Having at Least One FN Region (Right or Left Pelvis), Regardless of Any Coexisting TN Findings (Objective 5)
Central Reader 1
|
81.3 percentage
Interval 76.3 to 85.7
|
—
|
|
NPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FN Patient is Defined as Having at Least One FN Region (Right or Left Pelvis), Regardless of Any Coexisting TN Findings (Objective 5)
Central Reader 2
|
80.8 percentage
Interval 75.8 to 85.2
|
—
|
|
NPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FN Patient is Defined as Having at Least One FN Region (Right or Left Pelvis), Regardless of Any Coexisting TN Findings (Objective 5)
Central Reader 3
|
79.9 percentage
Interval 74.8 to 84.4
|
—
|
SECONDARY outcome
Timeframe: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administrationTP \[confirmed by SoT\] central BIE PET finding and negative conventional imaging finding from the local reading
Outcome measures
| Measure |
Efficacy Analysis Population
n=352 Participants
All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and who underwent RP and PLND
|
Extended Efficacy Population (EEP)
n=352 Participants
M1 lesions compared to histopathology or confirmatory imaging
|
|---|---|---|
|
The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a)
Central Reader 1
|
5.1 percentage
|
8.2 percentage
|
|
The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a)
Central Reader 2
|
4.3 percentage
|
12.2 percentage
|
|
The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a)
Central Reader 3
|
3.7 percentage
|
8.0 percentage
|
SECONDARY outcome
Timeframe: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administrationOutcome measures
| Measure |
Efficacy Analysis Population
n=352 Participants
All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and who underwent RP and PLND
|
Extended Efficacy Population (EEP)
M1 lesions compared to histopathology or confirmatory imaging
|
|---|---|---|
|
The Percentage of Patients in Whom Planned RP Was Converted to EBRT. (Objective 6b)
|
2.6 percentage
|
—
|
SECONDARY outcome
Timeframe: PET/CT scans on Day 1Population: All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan
Pairwise agreement between any 2 of the 3 readers (Kappa statistic could not be calculated for 2 of the pairwise agreements), and within readers between the initial read and re-read (Kappa statistics could not be calculated for 2 of the within-reader agreements)
Outcome measures
| Measure |
Efficacy Analysis Population
n=352 Participants
All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and who underwent RP and PLND
|
Extended Efficacy Population (EEP)
M1 lesions compared to histopathology or confirmatory imaging
|
|---|---|---|
|
Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7)
Agreement between initial read and re-read in Reader 1
|
100 percentage
|
—
|
|
Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7)
Agreement between initial read and re-read in Reader 2
|
100 percentage
|
—
|
|
Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7)
Agreement between initial read and re-read in Reader 3
|
95.7 percentage
|
—
|
|
Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7)
Agreement between reader 1 and reader 2
|
97.7 percentage
|
—
|
|
Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7)
Agreement between Reader 1 and Reader 3
|
95.2 percentage
|
—
|
|
Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7)
Agreement between Reader 2 and Reader 3
|
96.9 percentage
|
—
|
Adverse Events
Full Safety Population (FSP)
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Full Safety Population (FSP)
n=356 participants at risk
All patients who received the rhPSMA-7.3 (18F) injection. The FSP was used for all safety summaries.
|
|---|---|
|
Injury, poisoning and procedural complications
Tracheal deviation
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Vascular disorders
Aortic aneurysm
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Vascular disorders
Hypertension
|
0.56%
2/356 • Number of events 2 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Vascular disorders
Thrombophlebitis
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Cardiac disorders
Atrial fibrillation
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Nervous system disorders
Dysgeusia
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Nervous system disorders
Headache
|
1.4%
5/356 • Number of events 5 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
General disorders
Chills
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
General disorders
Injection site pain
|
0.84%
3/356 • Number of events 3 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
General disorders
Peripheral swelling
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Gastrointestinal disorders
Diarrhea
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Gastrointestinal disorders
Proctalgia
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Gastrointestinal disorders
Nausea
|
0.84%
3/356 • Number of events 3 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Psychiatric disorders
Anxiety
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Psychiatric disorders
Nervousness
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Renal and urinary disorders
Haematuria traumatic
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Infections and infestations
Urinary tract infection
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.28%
1/356 • Number of events 1 • All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place