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 @ 4:40 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
NCT ID:
NCT01029366
Description:
Adverse events during post-infusion period, regardless of study drug relationship, by primary system organ class and maximum CTC grade
Frequency Threshold:
5
Time Frame:
2 years
Study:
NCT01029366
Study Brief:
CART19 to Treat B-Cell Leukemia or Lymphoma That Are Resistant or Refractory to Chemotherapy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Chronic Lymphocytic Leukemia | CART-19 (autologous T cells transduced with CD19 TCR-ζ/4-1BB vector) administered as an IV infusion. Minimum/maximum total dose: 1.5x10\^7 / 5x10\^9. | None | None | 14 | 14 | 14 | 14 | View |
| Acute Lymphocytic Leukemia | CART-19 (autologous T cells transduced with CD19 TCR-ζ/4-1BB vector) administered as an IV infusion. Minimum/maximum total dose: 1.5x10\^7 / 5x10\^9. | None | None | 6 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cytokine Release Syndrome | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAEv3.0 | View |
| pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE | View |
| anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv3.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv3.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv3.0 | View |
| Tumor Lysis Syndrome | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv3.0 | View |
| Acute Kidney Injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEv3.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv3.0 | View |
| Chest Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3.0 | View |
| Clostridium difficle infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv3.0 | View |
| Haemolytic anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv3.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv3.0 | View |
| Histocytosis Haematophagic | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEv3.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEv3.0 | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv3.0 | View |
| Neutropenic sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv3.0 | View |
| Pneumonia fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv3.0 | View |
| Pseudomas Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv3.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3.0 | View |
| Confusion State | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEv3.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv3.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv3.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3.0 | View |
| White Blood Cell Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv3.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv3.0 | View |
| platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3.0 | View |
| Tumor Lysis Syndrome | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv3.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv3.0 | View |
| Blood Sosoim decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3.0 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv3.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv3.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEv3.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv3.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEv3.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3.0 | View |
| Blood Glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv3.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv3.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv3.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv3.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv3.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3.0 | View |
| Blood Glucose decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3.0 | View |
| Blood Magnesium decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3.0 | View |
| cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv3.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv3.0 | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv3.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3.0 | View |
| hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEv3.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEv3.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv3.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3.0 | View |
| ATrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv3.0 | View |
| Blood Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE | View |
| blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3.0 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3.0 | View |
| Blood phosphorous decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3.0 | View |
| Blood urinc acid increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3.0 | View |
| Confusion state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEv3.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3.0 | View |
| Blood Albumin decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE | View |
| Cytokine Release Syndrome | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAEv3.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv3.0 | View |
| Odema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv3.0 | View |
| Blood Calcium decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3.0 | View |