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:
NCT01072656
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT01072656
Study Brief:
Safety Study of Deep Brain Stimulation to Manage Thalamic Pain Syndrome
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase I-IV | Phase I-IV is time frame of patient consent through surgery just prior to beginning Active v Sham Stimulation Phase. | None | None | 0 | 9 | 9 | 9 | View |
| Active Stimulation (Phase V) | Active stimulation and programmed to the settings found to be optimal during the titration process. Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group. | None | None | 3 | 9 | 9 | 9 | View |
| Sham Stimulation (Phase V) | IPG is set to ON but the voltage is set to 0V. Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group. | None | None | 2 | 9 | 9 | 9 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute Post Hemorrhagic Anemia | None | Blood and lymphatic system disorders | None | View |
| Cellulitis | None | Blood and lymphatic system disorders | None | View |
| Kidney Stone Bacteremia | None | Renal and urinary disorders | None | View |
| Pulmonary Embolism | None | Cardiac disorders | None | View |
| Abscessed Tooth | None | Infections and infestations | None | View |
| Enterocolitis from C Diff | None | Blood and lymphatic system disorders | None | View |
| Appendectomy | None | Infections and infestations | None | View |
| Back surgery | None | Musculoskeletal and connective tissue disorders | None | View |
| FOCAL PARTIAL SEIZURE | None | Nervous system disorders | None | View |
| Complex Partial Seizure | None | Nervous system disorders | None | View |
| Right Burr Hole Dehiscence | None | Infections and infestations | None | View |
| Infection | None | Infections and infestations | None | View |
| Sepsis | None | Infections and infestations | None | View |
| Acute Gastric Ulcer w/out Hemorrhage or Perferation | None | Gastrointestinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Weakness | None | Musculoskeletal and connective tissue disorders | None | View |
| Patient Fall | None | Nervous system disorders | None | View |
| Agitation | None | Psychiatric disorders | None | View |
| Delirium | None | Psychiatric disorders | None | View |
| Redness from pulling at scab behind ear at head frame site | None | Skin and subcutaneous tissue disorders | None | View |
| Hypomania | None | Psychiatric disorders | None | View |
| Acid Reflux | None | Gastrointestinal disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Insomnia | None | Psychiatric disorders | None | View |
| Auditory Hallucinations | None | Psychiatric disorders | None | View |
| Scalp Soreness | None | Musculoskeletal and connective tissue disorders | None | View |
| Fatigue | None | Nervous system disorders | None | View |
| Increased Libido | None | Psychiatric disorders | None | View |
| Reoccurrence of chronic sciatica | None | Nervous system disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Symptoms from L5-S1 degerative disc disease | None | Musculoskeletal and connective tissue disorders | None | View |
| Urinary tract complicatoin | None | Renal and urinary disorders | None | View |
| Increased sleep | None | Psychiatric disorders | None | View |
| Increased sensitivity at bottom of feet | None | Nervous system disorders | None | View |
| Balance difficulty | None | Nervous system disorders | None | View |
| Left ankle pain/giving out | None | Musculoskeletal and connective tissue disorders | None | View |
| Itchy scalp | None | Skin and subcutaneous tissue disorders | None | View |
| Attention deficit disorder exacerbation | None | Psychiatric disorders | None | View |
| Diabetes III-controlled | None | Metabolism and nutrition disorders | None | View |
| Yeast infection | None | Reproductive system and breast disorders | None | View |
| Feels like extremities are in vice | None | Nervous system disorders | None | View |
| Outdoor temperature increases pain | None | Psychiatric disorders | None | View |
| Root canal | None | Musculoskeletal and connective tissue disorders | None | View |
| Eye infection | None | Eye disorders | None | View |
| Right hand pain | None | Nervous system disorders | None | View |
| Low back pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Worsening intensity of suicide ideation | None | Psychiatric disorders | None | View |
| Inguinal hernia | None | Gastrointestinal disorders | None | View |
| Worsening pain | None | Nervous system disorders | None | View |
| Difficulties concentrating | None | Psychiatric disorders | None | View |
| Torso extreme tightness | None | Nervous system disorders | None | View |
| When left side laying only, torso sweats | None | Nervous system disorders | None | View |
| Walking is more ataxic | None | Nervous system disorders | None | View |
| Increased pain with DBS turned off | None | Nervous system disorders | None | View |
| Infection | None | Infections and infestations | None | View |
| ED for BP spike | None | Vascular disorders | None | View |
| Influenza | None | Infections and infestations | None | View |
| Edema in right foot | None | Nervous system disorders | None | View |
| Carpel tunnel syndrome | None | Nervous system disorders | None | View |
| Intermittent leg twitch | None | Nervous system disorders | None | View |
| Infection from animal bite | None | Injury, poisoning and procedural complications | None | View |
| Carotid trickling | None | Vascular disorders | None | View |
| Essential hypertension | None | Vascular disorders | None | View |