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 @ 10:18 PM
Ignite Modification Date: 2025-12-25 @ 7:51 PM
NCT ID: NCT05053035
Description: None
Frequency Threshold: 0
Time Frame: 32 Weeks
Study: NCT05053035
Study Brief: A Phase 2 Study to Evaluate AL001 in C9orf72-Associated ALS
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AL001 AL001 every 4 weeks AL001: Administered via intravenous (IV) infusion 0 None 0 3 2 3 View
Placebo Placebo every 4 weeks Placebo: Administered via intravenous (IV) infusion 0 None 0 2 2 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Catheter site irritation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Medical device site hemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Post lumbar puncture syndrome SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Stoma site erythema SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Stoma site hypergranulation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Pneumonitis aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View