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 @ 9:42 PM
Ignite Modification Date: 2025-12-25 @ 7:23 PM
NCT ID: NCT04883632
Description: AEs will be detected at each visit by clinical examination and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject.In addition, the subjects will be instructed to immediately contact the investigator/study site in case of occurrence of any untoward event between visits.
Frequency Threshold: 0
Time Frame: 65 weeks. From day 0 ( IMP administration) until visit 9 ( week 65).
Study: NCT04883632
Study Brief: Saypha® Volume LIdocaine in Nasolabial Folds
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Volume Lidocaine HQ Subjects randomized to be treated with Saypha Volume Lidocaine manufactured in the Croma Pharma HQ Facility Saypha Volume Lidocaine: correction of Nasolabial Folds using injection of Saypha Volume Lidocaine manufactured in 2 different plants at Croma Pharma 0 None 1 54 16 54 View
Volume Lidocaine C1 Subjects randomized to be treated with Saypha Volume Lidocaine manufactured in the Croma Pharma C1 Facility Saypha Volume Lidocaine: correction of Nasolabial Folds using injection of Saypha Volume Lidocaine manufactured in 2 different plants at Croma Pharma 0 None 2 55 14 55 View
Overall Population (Saypha Volume Lidocaine HQ + C1) Subjects randomized to be treated with Saypha Volume Lidocaine manufactured in both facilities 0 None 3 109 30 109 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
intervertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
vertebral foraminal stenosis, NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Administration site haematoma NON_SYSTEMATIC_ASSESSMENT General disorders None View
Administration site pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Administration Site swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection Site Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders None View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
COVID 19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gingivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharingitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
vertebral foraminal stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Tonsilitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypercholesterolemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Intervertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle tightness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pathological fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Venous Trombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Application site Swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View