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 @ 9:36 PM
Ignite Modification Date: 2025-12-25 @ 7:19 PM
NCT ID: NCT03490032
Description: Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Study: NCT03490032
Study Brief: 68Ga-PSMA-R2 in Patients With Biochemical Relapse (BR) and Metastatic Prostate Cancer (mPCa)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\]. 0 None 0 6 1 6 View
Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\]. 0 None 1 12 4 12 View
Metastatic Prostate Cancer (mPCa) (Phase II) All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\]. 0 None 0 12 2 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (23.0) View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA (23.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (23.0) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (23.0) View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (23.0) View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (23.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (23.0) View