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 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
NCT ID:
NCT03994705
Description:
None
Frequency Threshold:
0
Time Frame:
Follow ups conducted on months 3,6,9,12.
Study:
NCT03994705
Study Brief:
Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Dose Level 3 | Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 100 million cells of Descartes-11 via intravenous catheter on Days 7,14 | 0 | None | 1 | 3 | 2 | 3 | View |
| Dose Level 1 | Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 10 million cells of Descartes-11 via intravenous catheter on Days 7,14 | 0 | None | 3 | 3 | 3 | 3 | View |
| Dose Level 2 | Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 32 million cells of Descartes-11 via intravenous catheter on Days 7,14 | 1 | None | 2 | 4 | 2 | 4 | View |
| Dose Level 4A | Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,14,21 | 0 | None | 1 | 2 | 1 | 2 | View |
| Dose Level 4B | Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,10,14,21 | 0 | None | 1 | 4 | 3 | 4 | View |
| Dose Level 4C | Participants were not administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 1,4, 7,10,14,21 | 1 | None | 0 | 4 | 2 | 4 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE VERSION 5.0 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE VERSION 5.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE VERSION 5.0 | View |
| Infusion reactions | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE VERSION 5.0 | View |
| Plasmacytoma | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE VERSION 5.0 | View |
| Dental Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE VERSION 5.0 | View |
| Acute Kidney Injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE VERSION 5.0 | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE VERSION 5.0 | View |
| Generalized weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE VERSION 5.0 | View |
| Pathologic fractures of right femur and left humerus | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE VERSION 5.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE VERSION 5.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE VERSION 5.0 | View |
| Fever, etiology unknown | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE VERSION 5.0 | View |
| Neck Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE VERSION 5.0 | View |
| Upper Resipratory Infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE VERSION 5.0 | View |
| Fever (preapheresis) | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE VERSION 5.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE VERSION 5.0 | View |
| Chronic Kidney Disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE VERSION 5.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE VERSION 5.0 | View |
| Dyspnea on exertion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE VERSION 5.0 | View |
| Granulocyte count decreased | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE VERSION 5.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE VERSION 5.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE VERSION 5.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE VERSION 5.0 | View |
| Neutropenic fever | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE VERSION 5.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE VERSION 5.0 | View |
| Fever (Etiology Unknown) | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE VERSION 5.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE VERSION 5.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE VERSION 5.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE VERSION 5.0 | View |
| Infusion Related Reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE VERSION 5.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE VERSION 5.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE VERSION 5.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE VERSION 5.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE VERSION 5.0 | View |