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 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
NCT ID:
NCT01389232
Description:
Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01389232
Study Brief:
The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SeriScaffold® Surgical Scaffold | Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold. | None | None | 53 | 100 | 92 | 100 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 18.0 | View |
| Capsular contracture associated with breast implant | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 18.0 | View |
| Device extrusion | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 18.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 18.0 | View |
| Mastitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 18.0 | View |
| Neutropenic sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 18.0 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 18.0 | View |
| Seroma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 18.0 | View |
| Wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 18.0 | View |
| Medical Device Complication | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 18.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 18.0 | View |
| Device Related Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 18.0 | View |
| Endometritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 18.0 | View |
| Staphylococcal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 18.0 | View |
| Fractured Sacrum | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 18.0 | View |
| Humerus Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 18.0 | View |
| Post Procedural Haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 18.0 | View |
| Basal Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | View |
| Breast Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | View |
| intraductal Proliferative Breast Lesion | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | View |
| Invasive Ductal Breast Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | View |
| Metastases to Spine | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | View |
| Abortion Spontaneous | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA version 18.0 | View |
| Placenta Previa | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA version 18.0 | View |
| Cervical Dysplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 18.0 | View |
| Ovarian Cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 18.0 | View |
| Pulmonary Fibrosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | View |
| Skin Atrophy | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | View |
| Physical examination abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 18.0 | View |
| Lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | View |
| Metastases to lymph nodes | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | View |
| Skin necrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 18.0 | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 18.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 18.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 18.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 18.0 | View |
| Device Dislocation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 18.0 | View |
| Inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 18.0 | View |
| Benign Breast Neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 18.0 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | View |
| Capsular contracture associated with breast implant | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 18.0 | View |
| Device dislocation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 18.0 | View |
| Device extrusion | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 18.0 | View |
| Impaired healing | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 18.0 | View |
| Implant site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 18.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 18.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 18.0 | View |
| Seroma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 18.0 | View |
| Wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 18.0 | View |
| Physical examination abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 18.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 18.0 | View |
| Breast pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 18.0 | View |
| Skin necrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 18.0 | View |