NCT02981368 · ADVERSE EVENTS

Adverse events

Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer · Source last updated 2021-08-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.
Other-event reporting threshold: 1%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
High Risk Prostate Cancer (Cohort A) Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	1 / 268	26 / 268	0 / 268
Recurrent or Metastatic Prostate Cancer (Cohort B) Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.	6 / 117	1 / 117	0 / 117

Group identifiers: EG000: High Risk Prostate Cancer (Cohort A) · EG001: Recurrent or Metastatic Prostate Cancer (Cohort B)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
268
group Id
EG001
num Affected
1
num At Risk
117
term
coronary artery disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
268
group Id
EG001
num Affected
1
num At Risk
117
term
atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
268
group Id
EG001
num Affected
1
num At Risk
117
term
Lower gastrointestinal haemmorhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
268
group Id
EG001
num Affected
1
num At Risk
117
term
pyelonephritis, acute
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
268
group Id
EG001
num Affected
1
num At Risk
117
term
hyperkalaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
268
group Id
EG001
num Affected
1
num At Risk
117
term
spinal cord compression

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
9
num At Risk
268
group Id
EG001
num Affected
1
num At Risk
117
term
dysgeusia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
9
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
117
term
headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
5
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
117
term
fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
3
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
117
term
diarrhea

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
268
description
Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
id
EG000
other Num Affected
26
other Num At Risk
268
serious Num Affected
1
serious Num At Risk
268
title
High Risk Prostate Cancer (Cohort A)
deaths Num Affected
0
deaths Num At Risk
117
description
Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
id
EG001
other Num Affected
1
other Num At Risk
117
serious Num Affected
6
serious Num At Risk
117
title
Recurrent or Metastatic Prostate Cancer (Cohort B)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
9
num At Risk
268
group Id
EG001
num Affected
1
num At Risk
117
term
dysgeusia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
9
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
117
term
headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
5
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
117
term
fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
3
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
117
term
diarrhea

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
268
group Id
EG001
num Affected
1
num At Risk
117
term
coronary artery disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
268
group Id
EG001
num Affected
1
num At Risk
117
term
atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
268
group Id
EG001
num Affected
1
num At Risk
117
term
Lower gastrointestinal haemmorhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
268
group Id
EG001
num Affected
1
num At Risk
117
term
pyelonephritis, acute
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
268
group Id
EG001
num Affected
1
num At Risk
117
term
hyperkalaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
0
num At Risk
268
group Id
EG001
num Affected
1
num At Risk
117
term
spinal cord compression

time Frame

Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.

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Preserved source evidence · Not medical advice