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 @ 4:58 PM
Ignite Modification Date:
2025-12-25 @ 2:39 PM
NCT ID:
NCT02042950
Description:
None
Frequency Threshold:
0
Time Frame:
21 months
Study:
NCT02042950
Study Brief:
A Phase II Study of Carfilzomib in the Treatment of Relapsed/Refractory Mantle Cell Lymphoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Carfilzomib | To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate. | 0 | None | 2 | 4 | 4 | 4 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Adrenal Insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (4.0) | View |
| Alk Phos Increase | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| AST Increase | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Bili Rubin Increase | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Blurred Vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Creatinine Increase | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Dry Eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Edema Limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Elevated BUN | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Elevated Lactic Acids | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyperuricemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypocalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypomagnesium | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Memory Impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Neutrophil Decrease | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Peripheral Sensory Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Platelet Count Decrease | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| White Blood Cell Decrease | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |