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 @ 11:14 PM
Ignite Modification Date: 2025-12-25 @ 8:49 PM
NCT ID: NCT01870869
Description: Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
Frequency Threshold: 5
Time Frame: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Study: NCT01870869
Study Brief: NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Augmentation Women who had breast augmentation with NATRELLE® 410 implants. None None 0 278 0 0 View
Revision-Augmentation Women who had revision of previous breast augmentation with NATRELLE® 410 implants. None None 0 201 0 0 View
Reconstruction Women who had breast reconstruction with NATRELLE® 410 implants. None None 7 1180 0 0 View
Revision-Reconstruction Women who had revision of previous breast reconstruction with NATRELLE® 410 implants. None None 1 225 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Breast cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pulmonary hypertension None Respiratory, thoracic and mediastinal disorders None View
Metastatic carcinoma to liver None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Recurrence of breast cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Liver cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Metastatic breast cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):