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 @ 3:37 PM
Ignite Modification Date: 2025-12-25 @ 1:49 PM
NCT ID: NCT03448692
Description: Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participants, or one participant may have experienced both a serious and non-serious event during the study.
Frequency Threshold: 5
Time Frame: From Day 1 of treatment up to 9 weeks after last dose of study treatment (up to Week 33)
Study: NCT03448692
Study Brief: A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PF-06730512 1000 mg IV Participants received PF-06730512 1000 mg IV Q2W. 0 None 2 23 11 23 View
PF-06730512 300 mg IV Participants received PF-06730512 300 mg IV Q2W. 0 None 2 24 12 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.1 View
Disease progression NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Hypervolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25.1 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v25.1 View
Renal impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v25.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25.1 View
SARS-CoV-2 test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.1 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25.1 View
Flank pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.1 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v25.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.1 View