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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
NCT ID:
NCT00002558
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00002558
Study Brief:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group: B > 6 Cycles of Cisplatin | Group B: Prior Treatment Limited to \> 6 Cycles of Cisplatin | None | None | 2 | 16 | 15 | 16 | View |
| Group A: <= 6 Cycles of Cisplatin | Group A: Prior Treatment Limited to \<= 6 Cycles of Cisplatin | None | None | 7 | 92 | 92 | 92 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| CNS hemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Neurology, other | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| Pulmonary, other | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Catheter related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTC-2.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-2.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTC-2.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTC-2.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-2.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Dermatology, skin other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTC-2.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-2.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | View |
| Edema | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Erythema multiforme | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTC-2.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Hearing, other | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTC-2.0 | View |
| Hemoglobin (Hgb) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Hemorrhage, other | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypermagnesmia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTC-2.0 | View |
| Infection with grade 3/4 neutopenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTC-2.0 | View |
| Leukocytes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Neuropathy-sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTC-2.0 | View |
| Neutrophils | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Pain, other | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Prothrombin time (PT) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Partial thromboplastin time (PTT) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Rash, desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTC-2.0 | View |
| SGOT (AST) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| SGPT (ALT) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-2.0 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-2.0 | View |
| Abdominal pain/cramping | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-2.0 | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | General disorders | CTC-2.0 | View |
| Bilirubin | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-2.0 | View |
| Catheter-related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTC-2.0 | View |