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 @ 7:21 PM
Ignite Modification Date:
2025-12-25 @ 5:00 PM
NCT ID:
NCT03026803
Description:
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Frequency Threshold:
0
Time Frame:
Adverse events occurred over a period of 3 months.
Study:
NCT03026803
Study Brief:
A Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular 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 |
|---|---|---|---|---|---|---|---|---|
| Oxaliplatin and Capecitabine | 21 day cycle with Oxaliplatin 50mg/m\^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m\^2 bid p.o. daily from day 1 to day 14 Oxaliplatin: Given IV Capecitabine: Given PO | None | None | 1 | 4 | 2 | 4 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Colitis, infectious (e.g., Clostridium difficile) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Lower gastrointestinal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Stomach pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Leukocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Blood glucose increased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum calcium decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum calcium increased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum magnesium decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum potassium decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra10.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra10.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra10.0 | View |
| Voice alteration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Rash desquamating | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra10.0 | View |
| Hemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra10.0 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Gastrointestinal disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra10.0 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra10.0 | View |
| Colitis, infectious (e.g., Clostridium difficile) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra10.0 | View |
| Creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra10.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Blood uric acid increased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum albumin decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum phosphate decreased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Serum potassium increased | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra10.0 | View |
| Muscle weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra10.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Taste alteration | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra10.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra10.0 | View |
| Pharyngolaryngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra10.0 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra10.0 | View |