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 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
NCT ID:
NCT03287804
Description:
None
Frequency Threshold:
0
Time Frame:
From Day 0 until Day 60 post last AUTO2 infusion.
Study:
NCT03287804
Study Brief:
APRIL CAR T Cells (AUTO2) Targeting BCMA and TACI for the Treatment of 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 |
|---|---|---|---|---|---|---|---|---|
| AUTO2 | Relapsed or refractory myeloma patients | 8 | None | 6 | 11 | 11 | 11 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Metaplastic breast carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (22.0) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | View |
| Hedache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Lung infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (22.0) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (22.0) | View |
| Haemophagocytic lymphohistiocytosis | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (22.0) | View |
| Catheter site bruise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.0) | View |
| Hallucination | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (22.0) | View |
| ALT increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| AST increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Blood ALP increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Blood creatinine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Respiratory syncytial virus test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Serum ferritin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.0) | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (22.0) | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (22.0) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (22.0) | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (22.0) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | View |
| Tachypnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Tension headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.0) | View |
| Ear disorder | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (22.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.0) | View |
| Micturition urgency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (22.0) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.0) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.0) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.0) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Musculoskeletal chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Musculoskeletal discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Fluid overload | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Hypophosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.0) | View |
| Enterovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| External ear cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Metapneumovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Parvovirus B19 infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Pseudomonal bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Rhinovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |
| Urinary tract infection enterococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.0) | View |