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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
NCT ID:
NCT04208958
Description:
AEs were recorded from the day of signing the ICF until 100 days after the last dose of study treatment or until alternate anticancer therapy was initiated, whichever occurred first. Thereafter, only SAEs were recorded during survival follow-up period or until alternate anticancer therapy was initiated. SAEs occurring after the start of a new treatment were reported if considered to be related to study treatment by the investigator.
Frequency Threshold:
5
Time Frame:
From the first dose to the last dose (up to 2 years), plus 100 days of post-treatment follow-up.
Study:
NCT04208958
Study Brief:
Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic 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 |
|---|---|---|---|---|---|---|---|---|
| VE800 combination treatment with nivolumab (Melanoma) | Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks. VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response. Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer. Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection. | 9 | None | 5 | 21 | 13 | 21 | View |
| VE800 combination treatment with nivolumab (Gastric) | Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks. VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response. Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer. Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection. | 12 | None | 9 | 21 | 16 | 21 | View |
| VE800 combination treatment with nivolumab (Colorectal) | Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks. VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response. Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer. Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection. | 10 | None | 2 | 14 | 11 | 14 | View |
| VE800 combination treatment with nivolumab (Total) | Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks. VE800: VE800 is a PO LBP consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response. Nivolumab: Nivolumab is an approved medication that blocks antibodies for certain types of cancer. Vancomycin Oral Capsule: Vancomycin is an antibiotic used to treat or prevent infection. | 31 | None | 16 | 56 | 40 | 56 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bacteremia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Alanine aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Pneumonia Aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary Oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Arthritis Infective | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Plural Effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Gastrointestinal Fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Intestinal Perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Aspartate Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood Creatine Phosphokinase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Troponin Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hepatitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Spinal Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Malnutrition | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Myositis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Cancer Pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Cerebrovascular Accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Superior Vena cava Syndrome | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal Distention | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal Pain - Upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Plural Effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Lymphocyte Count Decrease | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |