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 @ 3:23 AM
Ignite Modification Date: 2025-12-26 @ 2:02 AM
NCT ID: NCT02677805
Description: None
Frequency Threshold: 2
Time Frame: Up to 60 weeks post first treatment
Study: NCT02677805
Study Brief: Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study II
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Botulinum Toxin A Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area 0 None 0 160 12 160 View
Placebo Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area. Placebo: Injection, sodium chloride 0.9 % divided in five 0.1mL i.m. injections into glabellar area 0 None 0 53 2 53 View
Botulinum Toxin A Open Label Extension Arm Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 treatment cycles. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in up to 3 treatment cycles 0 None 2 195 18 195 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vitreous detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Adenomyosis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.0 View
Vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View