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:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:36 AM
NCT ID:
NCT03332160
Description:
None
Frequency Threshold:
0
Time Frame:
8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
Study:
NCT03332160
Study Brief:
A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Wait-list Control Group | Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate). | 1 | None | 2 | 24 | 20 | 24 | View |
| Interventional Group | Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable. | 0 | None | 2 | 19 | 14 | 19 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE V4.0 | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE V4.0 | View |
| Stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V4.0 | View |
| Sudden death NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE V4.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V4.0 | View |
| Gastroesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V4.0 | View |
| Aphonia | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE V4.0 | View |
| Respiratory, thoracic and mediastinal disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V4.0 | View |
| Wheezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V4.0 | View |
| Hyperthyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE V4.0 | View |
| Chest Pain - Cardiac | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE V4.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE V4.0 | View |
| Hearing impaired | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE V4.0 | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE V4.0 | View |
| Corneal ulcer | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE V4.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V4.0 | View |
| General disorders and administration site conditions - other specify | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE V4.0 | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE V4.0 | View |
| Oral pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE V4.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE V4.0 | View |
| Allergic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE V4.0 | View |
| Bladder infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE V4.0 | View |
| Eye infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE V4.0 | View |
| Middle ear inflammation | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE V4.0 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE V4.0 | View |
| Upper respiratory infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE V4.0 | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE V4.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V4.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V4.0 | View |
| Myelitis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V4.0 | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V4.0 | View |
| Spasiticity | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V4.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE V4.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V4.0 | View |
| Skin and subcutaneous tissue disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V4.0 | View |
| Skin infection | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE V4.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V4.0 | View |
| Hoarseness | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V4.0 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V4.0 | View |
| Postnasal drip | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE V4.0 | View |
| Gastrointestinal fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE V4.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE V4.0 | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V4.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE V4.0 | View |
| Surgical and medical procedures - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE V4.0 | View |
| Infection and infestation - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE V4.0 | View |