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 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
NCT ID:
NCT02161133
Description:
None
Frequency Threshold:
0
Time Frame:
9 months
Study:
NCT02161133
Study Brief:
Cognitive Rehabilitation for Gulf War Illness
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Problem-Solving Therapy | Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems. Problem-Solving Therapy: Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems. | 1 | None | 21 | 135 | 15 | 135 | View |
| Health Education | Health education provides didactic information about Gulf War Illness Health Education: Health Education provides didactic information about Gulf War Illness | 0 | None | 31 | 133 | 14 | 133 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Scheduled plastic surgery | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| ER Visit | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| ER Visit | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Kidney removed; no chemo or radiation at this time | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Unplanned surgery for intestinal blockage. | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| ER Visit | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | None | View |
| ER Visit | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| increasing emotionally labile, tearful, disorganized thinking | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| increased nightmares | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| ER visit | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| ER Visit | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Admitted to hospital for numbness in arm | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Admitted to hospital for severe abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Admitted to hospital for pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Overwhelmed from reflecting about GWI Sx. Felt better after journaling. | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Emotional difficulty during QI. Nighmares after Baseline Visit. | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hospitalized for abdominal pain; Dx with hernia and discharged 3 days after | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Admitted to hospital for passing out on motorcycle. | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hospitalized for same day posterior cervical laminectomy surgery. | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Increased depression and Suicidal Ideation. Has chronic SI. | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Cataract surgery; overnight stay. Increased dizziness. | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Hospital same day surgery for cyst removal from lower back. | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Increase in intensity of suicidal ideation without intent. Has a history of SI. | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Increased headaches; previous unreported passive SI when experience headache episode. | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| ER Visit | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hysterectomy surgery and overnight stay at hospital. ER on different day for abnormal amount of blee | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Dx with Kidney cancer; operation to remove cancer - hospitalized 2 days. | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Hip replacement and diagnosed with heart disease approx. 1 month after hip replacement | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Right nephrectomy due to mass found in kidney. Hospitalized for 2 days and discharged. | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Increased suicidal ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| ER Visit | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| distressing memories | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Allergic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Chest spasms | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Foot issue | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hand numbness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Sinusitis/bronchitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Herniated disk | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Extreme pain and heat in body | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Heartburn, vertigo | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Excessive daytime sleepiness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cramping L hand and R foot | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Rash on face, affecting eyes | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Left shoulder pain | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Rash on left ear | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Mononucleosis | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | None | View |
| Recurrence of IBS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pain up R arm and hand | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Increased frequency of nightmares as a result of increasing social activities | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Trouble with memory - signing name | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Torn bicep muscle playing ball | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Thrown out back from building shelves and drawers. | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Increased pain and sciatica due to increased exercise on treadmill/stationary bike. | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Increasing arthritis pain in foot since car accident 3 months ago. | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| ER Visit | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Increased frequency of nightmares to 1/week from 3-4 times/year. | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Passive SI without intent or plan. | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| PTSD symptoms | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |