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 @ 4:35 PM
Ignite Modification Date:
2025-12-25 @ 2:26 PM
NCT ID:
NCT03325166
Description:
Adverse experiences will be graded and recorded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment
Frequency Threshold:
5
Time Frame:
Adverse experiences will be recorded throughout the study and during the follow-up period (Up to 3 years).
Study:
NCT03325166
Study Brief:
Pembrolizumab and Magnetic Resonance Imaging With Ferumoxytol in Treating Patients With Non-small Cell Lung Cancer and Brain Metastases
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 (Pembrolizumab, Ferumoxytol MRI) | Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (or up to 32 cycles) in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI at baseline, 12 weeks after radiation, at suspected radiographic progression, and 6 weeks after suspected radiographic progression. Ferumoxytol: Given IV Laboratory Biomarker Analysis: Correlative studies Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV | 0 | None | 1 | 2 | 2 | 2 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Version 4 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NCI CTCAE Version 4 | View |
| Eye disorders- involuntary blinking | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | NCI CTCAE Version 4 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE Version 4 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Version 4 | View |
| Hypomagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Version 4 | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Version 4 | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE Version 4 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Version 4 | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Version 4 | View |
| Hypercalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Version 4 | View |
| Eye infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE Version 4 | View |
| Confusion | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NCI CTCAE Version 4 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Version 4 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Version 4 | View |
| Hematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE Version 4 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 4 | View |
| Limb edema | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Version 4 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Version 4 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE Version 4 | View |
| Elevated liver enzymes | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Version 4 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Version 4 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Version 4 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Version 4 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 4 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE Version 4 | View |
| Leukocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE Version 4 | View |
| Tooth infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE Version 4 | View |
| Bruising | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | NCI CTCAE Version 4 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE Version 4 | View |