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 @ 2:56 PM
Ignite Modification Date: 2025-12-25 @ 1:20 PM
NCT ID: NCT03077659
Description: Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Frequency Threshold: 0
Time Frame: 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy)
Study: NCT03077659
Study Brief: Trial of NanoPac® Focal Therapy in Subjects 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
NanoPac® 6 mg/mL NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy. 0 None 0 3 3 3 View
NanoPac® 10 mg/mL NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy. 0 None 0 3 2 3 View
NanoPac® 15 mg/mL NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy. 0 None 0 10 6 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Leucocystosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Vision Blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Procalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Local swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Viral URTI SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Urine flow decreased SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View