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 @ 3:52 AM
Ignite Modification Date: 2025-12-26 @ 2:41 AM
NCT ID: NCT01603602
Description: The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Frequency Threshold: 5
Time Frame: Baseline (Day 1) to end of the study (Week 12)
Study: NCT01603602
Study Brief: BOTOX® Treatment in Pediatric Upper Limb Spasticity
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BOTOX® 3 U/kg Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly OT. 0 None 1 78 12 78 View
BOTOX® 6 U/kg Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT). 0 None 3 77 15 77 View
Placebo Participants received intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. Participants received weekly OT. 0 None 1 79 17 79 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Osteochondrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Infectious mononucleosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View