Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 5:39 PM
Ignite Modification Date: 2025-12-25 @ 3:09 PM
NCT ID: NCT02981368
Description: None
Frequency Threshold: 1
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.
Study: NCT02981368
Study Brief: Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
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. 0 None 1 268 26 268 View
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. 0 None 6 117 1 117 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lower gastrointestinal haemmorhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
pyelonephritis, acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
spinal cord compression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View