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 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
NCT ID:
NCT01164202
Description:
None
Frequency Threshold:
5
Time Frame:
Up to the end of treatment, on the average of 36 months
Study:
NCT01164202
Study Brief:
Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Sunitinib | sunitinib (SUTENT®) 37.5 mg/d (3 cps of 12.5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year sunitinib malate: placebo 3cps/days 4 weeks over 6 during 1 year transarterial chemoembolization: chemoembolization | 32 | None | 14 | 39 | 27 | 39 | View |
| Placebo | placebo 3cps/days 4 weeks over 6 during 1 year Placebo: placebo 3cps/days 4 weeks over 6 during 1 year transarterial chemoembolization: chemoembolization | 30 | None | 13 | 38 | 36 | 38 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC version 4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC version 4.0 | View |
| hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC version 4.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC version 4.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC version 4.0 | View |
| Ascite | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC version 4.0 | View |
| Black stool | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC version 4.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC version 4.0 | View |
| Lumbar pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTC version 4.0 | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC version 4.0 | View |
| Neutrophiles | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC version 4.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC version 4.0 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTC version 4.0 | View |
| Bilirubin | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC version 4.0 | View |
| Hepatic disorder | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC version 4.0 | View |
| Endocardite | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTC version 4.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTC version 4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC version 4.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ALAT | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC version 4.0 | View |
| ASAT | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC version 4.0 | View |
| Increase GGT | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC version 4.0 | View |
| Bilirubine | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC version 4.0 | View |
| Liver failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC version 4.0 | View |
| Phosphatases alcalines | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTC version 4.0 | View |
| Hemoglobine | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC version 4.0 | View |
| Leucocytose | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC version 4.0 | View |
| Neutrophiles | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC version 4.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC version 4.0 | View |
| Arterial hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTC version 4.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC version 4.0 | View |
| Ascite | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC version 4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC version 4.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC version 4.0 | View |
| Lipase | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC version 4.0 | View |
| Hand-foot syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTC version 4.0 | View |
| Prothrombin time | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC version 4.0 | View |
| Encephalopathia | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTC version 4.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC version 4.0 | View |
| Liver pain | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTC version 4.0 | View |