Number of Participants With Randomized/Study Treatment-emergent Adverse Events (TEAE)
Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer · Source last updated 2025-01-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
From randomization till 30 days safety follow-up, assessed up to 66 months (Final Analysis cut-off date = 14-Dec-2023)
What was measured
In the Main Study, "randomized treatment" refers to the investigational arm (AAA617+BSC/BSoC) and the control arm (BSC/BSoC). In the sub-study, "study treatment" refers to the investigational arm (AAA617+BSC/BSoC) without randomization:
1. A randomized treatment-emergent adverse event (TEAE) is any adverse event that occurs from the start of randomized treatment to 30 days after the last administration of randomized treatment or prior to the initiation of subsequent anticancer treatment.
2. A study treatment-emergent adverse event (TEAE) is any adverse event that occurs from the start of study treatment to 30 days after the last administration of study treatment or prior to the initiation of subsequent anticancer treatment.
The distribution of randomized/study treatment-emergent adverse events (TEAEs) was done via the analysis of frequencies for TEAEs and Serious Adverse Event (TESAEs), through the monitoring of relevant clinical and laboratory safety parameters.
Analysis population: FAS Safety Analysis Set. A patient with multiple grades for an AE is only counted under the maximum grade. Drug-related is related to any study drug (177Lu-PSMA-617 or BSC/BSoC). Study treatment refers to 177Lu-PSMA-617+BSC/BSoC.
Groups in this outcome
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
non-randomized cohort (AAA617+ BS/BSOC) at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Patients were treated and followed up similarly to the AAA617+BSC/BSOC (investigational arm) patients in the main study
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
529
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
205
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
30
Reported measurements
TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
518
Not reported
Not reported
Not reported
Not reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
170
Not reported
Not reported
Not reported
Not reported
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
30
Not reported
Not reported
Not reported
Not reported
Serious TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
195
Not reported
Not reported
Not reported
Not reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
58
Not reported
Not reported
Not reported
Not reported
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
9
Not reported
Not reported
Not reported
Not reported
Grade 3/4/5 TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
284
Not reported
Not reported
Not reported
Not reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
79
Not reported
Not reported
Not reported
Not reported
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
11
Not reported
Not reported
Not reported
Not reported
Drug-related TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
451
Not reported
Not reported
Not reported
Not reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
59
Not reported
Not reported
Not reported
Not reported
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
19
Not reported
Not reported
Not reported
Not reported
Serious Drug-related TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
51
Not reported
Not reported
Not reported
Not reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
5
Not reported
Not reported
Not reported
Not reported
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
2
Not reported
Not reported
Not reported
Not reported
Drug-related grade 3/4/5 TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
152
Not reported
Not reported
Not reported
Not reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
8
Not reported
Not reported
Not reported
Not reported
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
6
Not reported
Not reported
Not reported
Not reported
TEAE leading to reduction of 177Lu-PSMA-617
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
30
Not reported
Not reported
Not reported
Not reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
0
Not reported
Not reported
Not reported
Not reported
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
2
Not reported
Not reported
Not reported
Not reported
TEAE leading to reduction of BSC/BSoC
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
17
Not reported
Not reported
Not reported
Not reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
7
Not reported
Not reported
Not reported
Not reported
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
1
Not reported
Not reported
Not reported
Not reported
TEAE leading to interruption of 177Lu-PSMA-617
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
85
Not reported
Not reported
Not reported
Not reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
2
Not reported
Not reported
Not reported
Not reported
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
4
Not reported
Not reported
Not reported
Not reported
TEAE leading to interruption of BSC/BSoC
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
50
Not reported
Not reported
Not reported
Not reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
14
Not reported
Not reported
Not reported
Not reported
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
1
Not reported
Not reported
Not reported
Not reported
TEAE leading to discontinuation of 177Lu-PSMA-617
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
63
Not reported
Not reported
Not reported
Not reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
1
Not reported
Not reported
Not reported
Not reported
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
2
Not reported
Not reported
Not reported
Not reported
TEAE leading to discontinuation of BSC/BSoC
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
47
Not reported
Not reported
Not reported
Not reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
16
Not reported
Not reported
Not reported
Not reported
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
0
Not reported
Not reported
Not reported
Not reported
Fatal TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
19
Not reported
Not reported
Not reported
Not reported
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
6
Not reported
Not reported
Not reported
Not reported
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
2
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
518
group Id
OG001
value
170
group Id
OG002
value
30
title
TEAE
categories
measurements
group Id
OG000
value
195
group Id
OG001
value
58
group Id
OG002
value
9
title
Serious TEAE
categories
measurements
group Id
OG000
value
284
group Id
OG001
value
79
group Id
OG002
value
11
title
Grade 3/4/5 TEAE
categories
measurements
group Id
OG000
value
451
group Id
OG001
value
59
group Id
OG002
value
19
title
Drug-related TEAE
categories
measurements
group Id
OG000
value
51
group Id
OG001
value
5
group Id
OG002
value
2
title
Serious Drug-related TEAE
categories
measurements
group Id
OG000
value
152
group Id
OG001
value
8
group Id
OG002
value
6
title
Drug-related grade 3/4/5 TEAE
categories
measurements
group Id
OG000
value
30
group Id
OG001
value
0
group Id
OG002
value
2
title
TEAE leading to reduction of 177Lu-PSMA-617
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
7
group Id
OG002
value
1
title
TEAE leading to reduction of BSC/BSoC
categories
measurements
group Id
OG000
value
85
group Id
OG001
value
2
group Id
OG002
value
4
title
TEAE leading to interruption of 177Lu-PSMA-617
categories
measurements
group Id
OG000
value
50
group Id
OG001
value
14
group Id
OG002
value
1
title
TEAE leading to interruption of BSC/BSoC
categories
measurements
group Id
OG000
value
63
group Id
OG001
value
1
group Id
OG002
value
2
title
TEAE leading to discontinuation of 177Lu-PSMA-617
categories
measurements
group Id
OG000
value
47
group Id
OG001
value
16
group Id
OG002
value
0
title
TEAE leading to discontinuation of BSC/BSoC
denoms
counts
group Id
OG000
value
529
group Id
OG001
value
205
group Id
OG002
value
30
units
Participants
description
In the Main Study, "randomized treatment" refers to the investigational arm (AAA617+BSC/BSoC) and the control arm (BSC/BSoC). In the sub-study, "study treatment" refers to the investigational arm (AAA617+BSC/BSoC) without randomization:
1. A randomized treatment-emergent adverse event (TEAE) is any adverse event that occurs from the start of randomized treatment to 30 days after the last administration of randomized treatment or prior to the initiation of subsequent anticancer treatment.
2. A study treatment-emergent adverse event (TEAE) is any adverse event that occurs from the start of study treatment to 30 days after the last administration of study treatment or prior to the initiation of subsequent anticancer treatment.
The distribution of randomized/study treatment-emergent adverse events (TEAEs) was done via the analysis of frequencies for TEAEs and Serious Adverse Event (TESAEs), through the monitoring of relevant clinical and laboratory safety parameters.
groups
description
Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used
id
OG000
title
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
description
Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator
id
OG001
title
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
description
non-randomized cohort (AAA617+ BS/BSOC) at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Patients were treated and followed up similarly to the AAA617+BSC/BSOC (investigational arm) patients in the main study
id
OG002
title
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
param Type
NUMBER
population Description
FAS Safety Analysis Set. A patient with multiple grades for an AE is only counted under the maximum grade. Drug-related is related to any study drug (177Lu-PSMA-617 or BSC/BSoC). Study treatment refers to 177Lu-PSMA-617+BSC/BSoC.
reporting Status
POSTED
time Frame
From randomization till 30 days safety follow-up, assessed up to 66 months (Final Analysis cut-off date = 14-Dec-2023)
title
Number of Participants With Randomized/Study Treatment-emergent Adverse Events (TEAE)
Triangle