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 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
NCT ID:
NCT00623805
Description:
Safety population: All participants who received at least 1 dose of study drug.
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00623805
Study Brief:
A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal 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 |
|---|---|---|---|---|---|---|---|---|
| Bevacizumab+Capecitabine+Oxaliplatin | Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression. | None | None | 12 | 62 | 62 | 62 | View |
| Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C | Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression. | None | None | 21 | 61 | 61 | 61 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Acute abdomen | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Acute renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (Unspecified) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Clinical worsening | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Decreased breath sounds on right lower zone | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (Unspecified) | View |
| Defence, distension and rigidity in abdomen | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Difficulty in breathing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Laryngeal edema | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (Unspecified) | View |
| H1N1 infection (influenza) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| High level of tiredness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
| Neutropenic fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Rapid advanced dyspnea and cyanosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
| Rectovaginal fistule | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Severe backache, shivering | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| General situational failure | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Weakness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Hemifacial spasm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (Unspecified) | View |