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 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
NCT ID:
NCT01143402
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01143402
Study Brief:
Temozolomide or Selumetinib in Treating Patients With Metastatic Melanoma of the Eye
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm I (Temozolomide) | Randomized to Temozolomide | None | None | 18 | 50 | 50 | 50 | View |
| Arm II (Selumetinib) | Randomized to Selumetinib | None | None | 19 | 49 | 49 | 49 | View |
| Non-Randomized (Selumetinib) | Non-Randomized to Selumetinib | None | None | 7 | 18 | 18 | 18 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| CPK increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-4.0 | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTC-4.0 | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTC-4.0 | View |
| Hepatobiliary disorders | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTC-4.0 | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-4.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Neoplasms | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTC-4.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTC-4.0 | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTC-4.0 | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTC-4.0 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-4.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-4.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Death NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-4.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-4.0 | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| GGT increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-4.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-4.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-4.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-4.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-4.0 | View |
| General Disorders | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |
| Alanine Amino Transferase Elevation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Arthralgias | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTC-4.0 | View |
| Aspartate Amino Transferase Elevation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |
| Blurred Vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTC-4.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-4.0 | View |
| CPK Elevation | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-4.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTC-4.0 | View |
| Edema Face | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Eye Disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | CTC-4.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Mucositis | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-4.0 | View |
| Pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTC-4.0 | View |
| Rash Acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTC-4.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTC-4.0 | View |
| Edema Limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTC-4.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-4.0 | View |