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 @ 3:43 PM
Ignite Modification Date:
2025-12-25 @ 1:51 PM
NCT ID:
NCT00557492
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00557492
Study Brief:
Efficacy of Neoadjuvant Chemoradiation for Potentially Resectable Pancreas 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 |
|---|---|---|---|---|---|---|---|---|
| FDR GEM + BEV +/- BEV/RT | Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m\^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85. | None | None | 10 | 59 | 50 | 59 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Wound complication, non-infectious | None | Skin and subcutaneous tissue disorders | None | View |
| Dehydration | None | Gastrointestinal disorders | None | View |
| Leak (including anastomotic), GI, Pancreas | None | Gastrointestinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Obstruction, GI, Small bowel NOS | None | Gastrointestinal disorders | None | View |
| Hemorrhage/Bleeding | None | Blood and lymphatic system disorders | None | View |
| Hepatobiliary/Pancreas | None | Hepatobiliary disorders | None | View |
| Infection | None | Infections and infestations | None | View |
| Pain, Abdomen NOS | None | General disorders | None | View |
| Thrombosis/thrombus/embolism | None | Vascular disorders | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils, Abdomen NOS | None | Infections and infestations | 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 |
| Platelets | None | Blood and lymphatic system disorders | None | View |
| Neutrophils/granulocytes (ANC/AGC) | None | Blood and lymphatic system disorders | None | View |
| Hemoglobin | None | Blood and lymphatic system disorders | None | View |
| Fatigue (asthenia, lethargy, malaise) | None | General disorders | None | View |
| Dermatology/Skin | None | Skin and subcutaneous tissue disorders | None | View |
| Hair loss/alopecia (scalp or body) | None | Skin and subcutaneous tissue disorders | None | View |
| Pruritus/itching | None | Skin and subcutaneous tissue disorders | None | View |
| Rash/desquamation | None | Skin and subcutaneous tissue disorders | None | View |
| Wound complication, non-infectious | None | Skin and subcutaneous tissue disorders | None | View |
| Gastrointestinal | None | Gastrointestinal disorders | None | View |
| Anorexia | None | Gastrointestinal disorders | None | View |
| Constipation | None | Gastrointestinal disorders | None | View |
| Diarrhea | None | Gastrointestinal disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Calcium, serum-low (hypocalcemia) | None | Metabolism and nutrition disorders | None | View |
| Bilirubin (hyperbilirubinemia) | None | Metabolism and nutrition disorders | None | View |
| Potassium, serum-low (hypokalemia) | None | Metabolism and nutrition disorders | None | View |
| Albumin, serum-low (hypoalbuminemia) | None | Metabolism and nutrition disorders | None | View |
| Sodium, serum-low (hyponatremia) | None | Metabolism and nutrition disorders | None | View |
| Alkaline phosphatase | None | Metabolism and nutrition disorders | None | View |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | None | Metabolism and nutrition disorders | None | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | None | Metabolism and nutrition disorders | None | View |
| Glucose, serum-high (hyperglycemia) | None | Metabolism and nutrition disorders | None | View |
| Musculoskeletal/Soft Tissue | None | Musculoskeletal and connective tissue disorders | None | View |
| Mood alteration, Anxiety | None | Nervous system disorders | None | View |
| Pain | None | General disorders | None | View |
| Pain, Head/headache | None | General disorders | None | View |
| Pain, Abdomen NOS | None | General disorders | None | View |
| Pulmonary/Upper Respiratory | None | Respiratory, thoracic and mediastinal disorders | None | View |