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 @ 4:11 PM
Ignite Modification Date:
2025-12-25 @ 2:11 PM
NCT ID:
NCT00593866
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00593866
Study Brief:
Dose-Escalation Study of Intensity-Modulated Radiotherapy(IMRT)in Patients With Unresectable Pancreatic 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 |
|---|---|---|---|---|---|---|---|---|
| Radiation Dose Escalation With Gemcitabine | INTENSITY MODULATED RADIOTHERAPY Radiation dose escalation: Total dose Dose per fraction BED\* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4 * BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level Gemcitabine: 1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment | None | None | 34 | 50 | 31 | 50 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutrophils/granulocytes (ANC/AGC) | None | Blood and lymphatic system disorders | None | View |
| Fatigue | None | General disorders | None | View |
| Rigors/chills | None | General disorders | None | View |
| Weight loss | None | General disorders | None | View |
| Ascites (non-malignant) | None | Gastrointestinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Hemorrhage, GI, Abdomen NOS | None | Vascular disorders | None | View |
| Infection with Grade 3 or 4 neutrophils, Abdomen | None | Infections and infestations | None | View |
| Infection with Grade 3 or 4 neutrophil, Blood | None | Infections and infestations | None | View |
| Infection with Grade 3 or 4 neutrophils, Duodenum | None | Infections and infestations | None | View |
| Infection with Grade 3 or 4 neutrophils, Lung | None | Infections and infestations | None | View |
| Infection, Duodenum | None | Infections and infestations | None | View |
| Infection, Blood | None | Infections and infestations | None | View |
| Edema: limb | None | General disorders | None | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | None | Metabolism and nutrition disorders | None | View |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | None | Metabolism and nutrition disorders | None | View |
| Alkaline phosphatase | None | Metabolism and nutrition disorders | None | View |
| Glucose, serum-high (hyperglycemia) | None | Metabolism and nutrition disorders | None | View |
| Muscle weakness | None | Musculoskeletal and connective tissue disorders | None | View |
| Pain, Abdomen | None | Gastrointestinal disorders | None | View |
| Pain, Penis | None | Renal and urinary disorders | None | View |
| Pleural effusion (non-malignant) | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Renal failure | None | Renal and urinary disorders | None | View |
| Thrombosis/thrombus/embolism | None | Vascular disorders | None | View |
| Anemia | None | Blood and lymphatic system disorders | None | View |
| Leukocytes (total WBC) | None | Blood and lymphatic system disorders | None | View |
| Lymphopenia | None | Blood and lymphatic system disorders | None | View |
| Platelets | None | Blood and lymphatic system disorders | None | View |
| Hypotension | None | Cardiac disorders | None | View |
| Fever | None | General disorders | None | View |
| Rash/desquamation | None | Skin and subcutaneous tissue disorders | None | View |
| Anorexia | None | Gastrointestinal disorders | None | View |
| Obstruction, GI, Stomach | None | Gastrointestinal disorders | None | View |
| Ulcer, GI, Duodenum | None | Gastrointestinal disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Hemorrhage, GI, Duodenum | None | Vascular disorders | None | View |
| Hemorrhage, GI, Varices | None | Vascular disorders | None | View |
| Hepatobiliary/Pancreas - Other | None | Hepatobiliary disorders | None | View |
| Liver dysfunction/failure | None | Hepatobiliary disorders | None | View |
| Infection, Skin | None | Infections and infestations | None | View |
| Infection, Urinary Tract | None | Infections and infestations | None | View |
| Potassium, serum-high (hyperkalemia) | None | Metabolism and nutrition disorders | None | View |
| Potassium, serum-low (hypokalemia) | None | Metabolism and nutrition disorders | None | View |
| Confusion | None | Nervous system disorders | None | View |
| Neurology - Other | None | Nervous system disorders | None | View |
| Pain, Chest | None | Cardiac disorders | None | View |
| Pain, Extremity-limb | None | Musculoskeletal and connective tissue disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Leukocytes (total WBC) | None | Blood and lymphatic system disorders | None | View |
| Lymphopenia | None | Blood and lymphatic system disorders | None | View |
| Neutrophils/granulocytes (ANC/AGC) | None | Blood and lymphatic system disorders | None | View |
| Platelets | None | Blood and lymphatic system disorders | None | View |
| Fatigue | None | General disorders | None | View |
| Fever | None | General disorders | None | View |
| Anorexia | None | Gastrointestinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Hemorrhage, GI | None | Vascular disorders | None | View |
| Hepatobiliary/Pancreas | None | Hepatobiliary disorders | None | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | None | Metabolism and nutrition disorders | None | View |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | None | Metabolism and nutrition disorders | None | View |
| Glucose, serum-high (hyperglycemia) | None | Metabolism and nutrition disorders | None | View |
| Pain, Abdomen | None | Gastrointestinal disorders | None | View |
| Anemia | None | Blood and lymphatic system disorders | None | View |