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: 2025-12-25 @ 4:57 AM
Ignite Modification Date: 2025-12-26 @ 3:57 AM
NCT ID: NCT05592418
Description: AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Frequency Threshold: 1
Time Frame: 14 weeks
Study: NCT05592418
Study Brief: Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ampligen / Rintatolimod Subjects received rintatolimod (intravenous \[IV\]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly 0 None 0 40 10 40 View
Placebo / Saline Subjects received placebo / normal saline (intravenous \[IV\]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly 0 None 0 40 4 40 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 25.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 25.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 25.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 25.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 25.0 View
Feeling abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 25.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 25.0 View
Injection site phlebitis SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 25.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 25.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 25.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 25.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 25.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 25.0 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 25.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 25.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 25.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 25.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 25.0 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 25.0 View
Peripheral coldness SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 25.0 View
Eustachian tube obstruction SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA Version 25.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 25.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 25.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 25.0 View