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 @ 11:38 PM
Ignite Modification Date: 2025-12-25 @ 9:28 PM
NCT ID: NCT01526356
Description: Serious adverse events were determined to be unrelated to study drug.
Frequency Threshold: 1.1
Time Frame: 6 months
Study: NCT01526356
Study Brief: Topical Rapamycin to Erase Angiofibromas in TSC
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Cream only Placebo: Study cream is applied nightly to the affected areas on the face. 0 None 1 59 10 59 View
0.1 % Rapamycin 0.1% Rapamycin cream Rapamycin: Study cream is applied nightly to the affected areas on the face. Low Dose 0 None 1 63 18 63 View
1% Rapamycin 1% Rapamycin cream Rapamycin: Study cream is applied nightly to the affected areas on the face. High Dose 0 None 2 57 22 57 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
cholecystectomy SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Subependymal Giant Cell Astrocytoma (SEGA) resection SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Application site pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Application site acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Cutaneous eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Application site erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Sunburn SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Application site irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Application site paraesthesia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Mouth ulceration SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasal congestion SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Application site papules SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View