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: 2025-12-26 @ 11:13 PM
Ignite Modification Date: 2025-12-26 @ 11:13 PM
NCT ID: NCT02913612
Description: 0 participants in the historical control arm were at risk for Adverse Events because they did not prospectively participate in this research study. Only data that had already been collected was used in this study.
Frequency Threshold: 0
Time Frame: Any event excluding adverse events of special interest beginning more than 7 days after the last dose of study drug or last study procedure will not be reported. For participants in the treatment arm adverse events of special interest only will be reviewed and reported at 90 days after the last dose of study drug.
Study: NCT02913612
Study Brief: Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants With Infantile Hemangioma (IH)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
0.25% Timolol Treatment Subjects assigned to this arm will be randomized to 0.25% timolol for 180 days. If during the 180 days the subject is considered a treatment failure, the subject will be unblinded. If the subject is on 0.25% timolol they will be changed to 0.5% timolol. 0.25% Timolol Maleate Gel Forming Solution: 50:50 Randomized 0.25% Timolol Maleate Gel Forming Solution 0 None 3 44 31 44 View
0.5% Timolol Treatment Subjects assigned to this arm will be randomized to 0.5% timolol for 180 days. If during the 180 days the subject is considered a treatment failure, the subject will be unblinded. If the subject is on 0.5% timolol the treating physician will decide to either continue 0.5% timolol or withdraw the subject and begin an alternative treatment. 0.5% Timolol Maleate Gel Forming Solution: 50:50 Randomized 0.5% Timolol Maleate Gel Forming Solution 0 None 2 51 28 51 View
Non-Intervention Group Subjects assigned to this group will not receive treatment. The subject will only be photographed on the same schedule as the intervention group. 0 None 0 10 4 10 View
Historical Controls To obtain sufficient age-matched controls, data and clinical photographs collected as part of a similar study (EudraCT 2013-005199-17) were included in the analysis of certain outcome measures as noted in the Analysis Population Description of those measures. 0 None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory syncytial virus bronchiolitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchiolitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Influenza SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dacryostenosis congenital SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Plagiocephaly SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Amblyopia SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT General disorders None View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Teething SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Vaccination site pain SYSTEMATIC_ASSESSMENT General disorders None View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Candida nappy rash SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conjunctivitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations None View
Coxsackie viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Croup infectious SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hand-foot-and-mouth disease SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpangina SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media chronic SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory syncytial virus bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral rash SYSTEMATIC_ASSESSMENT Infections and infestations None View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Scar SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Crystal urine present SYSTEMATIC_ASSESSMENT Investigations None View
Dairy intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypotonia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Apnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cyanosis central SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis diaper SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Milia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Seborrhoeic dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Peripheral coldness SYSTEMATIC_ASSESSMENT Vascular disorders None View