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 @ 3:25 PM
Ignite Modification Date:
2025-12-25 @ 1:42 PM
NCT ID:
NCT02706392
Description:
The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4 was used for grading and analysis of adverse events. All grade 3 or greater adverse events were collected from time of leukapheresis until commencement of new anti-tumor therapy or until one year post infusion, whichever came first.
Frequency Threshold:
0
Time Frame:
Up to one year following last infusion per patient
Study:
NCT02706392
Study Brief:
Genetically Modified T-Cell Therapy in Treating Patients With Advanced ROR1+ Malignancies
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort A Dose Level 1 | Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study. | 1 | None | 1 | 2 | 2 | 2 | View |
| Cohort A Dose Level 2 | Patients with ROR1+ CLL, MCL or ALL that are refractory to conventional therapy will be eligible for Cohort A. Dose level 2 will be up to 1x106 EGFRt+ cells/kg. | 0 | None | 1 | 1 | 1 | 1 | View |
| Cohort B Dose Level 1 | Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 1 will be up to 3.3x105 EGFRt+ cells/kg. This is the starting dose for the study. | 2 | None | 1 | 2 | 2 | 2 | View |
| Cohort B Dose Level 2 | Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 2 will be up to 1x106 EGFRt+ cells/kg. | 2 | None | 2 | 3 | 3 | 3 | View |
| Cohort B Dose Level 3 | Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 3 will be up to 3.3x106 EGFRt+ cells/kg. | 5 | None | 10 | 11 | 11 | 11 | View |
| Cohort B Dose Level 4 | Patients with ROR1+ NSCLC or TNBC who have failed conventional chemotherapy or targeted therapy, or for whom these therapies are not effective will be eligible for Cohort B. Dose level 4 will be up to 1.0x107 EGFRt+ cells/kg | 2 | None | 2 | 2 | 2 | 2 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cytokine release syndrome | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cytokine release syndrome | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Fibrinogen decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyperuricemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |