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 @ 2:39 AM
Ignite Modification Date: 2025-12-26 @ 1:17 AM
NCT ID: NCT00538434
Description: None
Frequency Threshold: 5
Time Frame: Baseline through Safety Follow-up (Week 16)
Study: NCT00538434
Study Brief: Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Reslizumab 1 mg/kg reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles None None 1 55 38 55 View
Reslizumab 2 mg/kg reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles None None 1 57 29 57 View
Placebo saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles None None 2 57 40 57 View
Reslizumab 3 mg/kg reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles None None 1 57 39 57 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
GASTROINTESTINAL INFLAMMATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
ANAPHYLACTIC REACTION SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.0 View
GASTROENTERITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
RESPIRATORY DISTRESS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
VIRAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
PROTEIN URINE SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
URINARY CASTS SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
URINE OXALATE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
PHARYNGOLARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
ECZEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
GASTROENTERITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
OTITIS MEDIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
PHARYNGITIS STREPTOCOCCAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
RED BLOOD CELLS URINE POSITIVE SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
WHITE BLOOD CELLS URINE POSITIVE SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View