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 @ 4:26 PM
Ignite Modification Date: 2025-12-25 @ 2:19 PM
NCT ID: NCT01585766
Description: None
Frequency Threshold: 5
Time Frame: AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
Study: NCT01585766
Study Brief: Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MEDI-551 60 Mg-SC Participants received SC injection of 60 mg MEDI-551 on Day 1. None None 0 3 3 3 View
MEDI-551 300 Mg-SC Participants received SC injection of 300 mg MEDI-551 on Day 1. None None 1 3 2 3 View
PLACEBO-IV-SC Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1. None None 1 7 5 7 View
MEDI-551 100 Mg-IV Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15. None None 0 4 3 4 View
MEDI-551 30 Mg-IV Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15. None None 1 5 4 5 View
MEDI-551 600 Mg-IV Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15. None None 1 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Multiple sclerosis relapse SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Multiple sclerosis relapse SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Urinary tract inflammation SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View