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 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
NCT ID:
NCT03721705
Description:
3 participants from active sham group were migrated to treatment group.
Frequency Threshold:
2
Time Frame:
The period from signing informed consent to the end of the study treatment follow-up (Month 12).
Study:
NCT03721705
Study Brief:
Renew NCP-5 for the Treatment of Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild Dementia of the Alzheimer's Type
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Treatment Arm | The first four sessions will be the escalation phase using the Renew NCP-5. There will be a 5-minute ramp up period where the pressure is increased 1 psi/min until the desired pressure is reached. The goal for the treatment group will be at least 2.5 psi for the first treatment, and then escalate the pressure gradually through the fourth session with an average goal of 3 psi/session. After the fourth session, the pressure will be slowly increased to reach the maximum level the subject can tolerate with a goal of reaching 3-6 psi. Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks. | 0 | None | 8 | 98 | 41 | 98 | View |
| Sham Arm | The subjects will receive the same initial and maintenance treatment regimen on the Renew NCP-5. The pressure will not exceed an average of 0.5 psi over all treatments. Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks. | 1 | None | 9 | 92 | 31 | 92 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Endometrial Cancer | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Coronavirus Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Cervical Vertebral Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hip Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Amyotrophic Lateral Sclerosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Transient Ischemic Attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Urinary Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Skin Irritation/Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Dehydration/Fluid Volume Decrease | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastrointestinal Upset | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Joint Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Limb Fractures | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Nausea and Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dental pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headaches | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Coughing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Skin discomfort | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Infections, other | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Muscles/Tendon/Ligament injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Numbness/Tingling | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Itch | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Rate and Rhythm Disorders, Other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Coronavirus Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| General pain and discomfort | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Spinal Fractures | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Elevated Blood Pressure | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Non-Site Specific Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Supraventricular Arrhythmias | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Site specific injuries, other | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |