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 @ 2:41 PM
Ignite Modification Date:
2025-12-25 @ 1:12 PM
NCT ID:
NCT01180959
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
Study:
NCT01180959
Study Brief:
Erlotinib Plus Bevacizumab in Hepatocellular Carcinoma (HCC) as Second-line Therapy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Erlotinib + Bevacizumab | Erlotinib 150 mg by mouth once a day. Bevacizumab 10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes. Bevacizumab: 10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes Erlotinib: 150 mg by mouth once a day. | 33 | None | 0 | 44 | 40 | 44 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acneiform Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Dry Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Bruising | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Lower GI hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Upper GI Hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Fever without neutropenia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Weight Loss | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| General Disorder, other | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Pain (Head) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain (Back) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain (Abdomen) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain (Muscle) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain (Other) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Elevated transaminase | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Hand-Foot Syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Pul. Hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Hyperbilirubinemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dry Eyes | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Hyperpigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Nail Changes | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Taste Changes | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Voice Changes | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Syncopy attacks | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Thrombus formation | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |