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 @ 4:45 PM
Ignite Modification Date:
2025-12-25 @ 2:32 PM
NCT ID:
NCT02111850
Description:
None
Frequency Threshold:
0
Time Frame:
Date treatment consent signed to date off study, an average of 17 months.
Study:
NCT02111850
Study Brief:
T Cell Receptor Immunotherapy Targeting MAGE-A3 for Patients With Metastatic Cancer Who Are HLA-DP0401 Positive
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2 | Arm 1 Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^7 Cells + Interleukin-2 | 1 | None | 0 | 1 | 1 | 1 | View |
| Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2 | Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^7 Cells + Interleukin-2 | 1 | None | 0 | 1 | 1 | 1 | View |
| Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2 | Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^8 Cells + Interleukin-2 | 0 | None | 0 | 1 | 1 | 1 | View |
| Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2 | Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^8 Cells + Interleukin-2 | 1 | None | 0 | 1 | 1 | 1 | View |
| Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2 | Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^9 Cells + Interleukin-2 | 1 | None | 0 | 2 | 2 | 2 | View |
| Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2 | Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^9 Cells + Interleukin-2 | 0 | None | 0 | 1 | 1 | 1 | View |
| Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2 | Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^10 Cells + Interleukin-2 | 1 | None | 1 | 1 | 1 | 1 | View |
| Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2 | Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^10 Cells + Interleukin-2 | 1 | None | 0 | 1 | 1 | 1 | View |
| Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2 | Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^11 Cells + Interleukin-2 | 5 | None | 3 | 6 | 6 | 6 | View |
| Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other | Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Other | 4 | None | 3 | 5 | 5 | 5 | View |
| Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma | Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Melanoma | 1 | None | 1 | 1 | 1 | 1 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pleural effusion (non-malignant) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Psychosis (hallucinations/delusions) | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Renal/Genitourinary - Other (Oliguria) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Supraventricular and nodal arrhythmia: Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Thrombosis/embolism (vascular access-related) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| AST, SGOT (serum glutamic oxaloacetic transaminase) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Colitis, infectious (e.g., Clostridium difficile) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Bilirubin (hyperbilirubinemia) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Bronchopulmonary hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Laryngeal hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Lymphocytes count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| PTT (Partial Thromboplastin Time) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Pain: Head/headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Potassium, serum-low (hypokalemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Psychosis (hallucinations/delusions) | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Purpura | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Renal/Genitourinary - Other (Oliguria) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Renal/Genitourinary - Other (Renal Insufficiency) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Sodium, serum-low (hyponatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Supraventricular and nodal arrhythmia: Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Urine output decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Platelets count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |