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 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
NCT ID:
NCT03639935
Description:
Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints as data is still being collected.
Frequency Threshold:
5
Time Frame:
All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 5 year period.
Study:
NCT03639935
Study Brief:
Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum 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 |
|---|---|---|---|---|---|---|---|---|
| Rucaparib and Nivolumab | Rucaparib 600 mg PO BID days 1-28 Nivolumab 240 mg IV days 1 and 15 Rucaparib: Rucaparib 600 mg PO BID days 1-28 Nivolumab: Nivolumab 240 mg IV days 1 and 15 | 26 | None | 17 | 31 | 28 | 31 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Upper respiratory infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Muscle weakness right-sided | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Bullous dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Obstruction gastric | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Biliary tract infection | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Gastrointestinal disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Thromboembolic event | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Heart failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Infections and infestations - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Surgical and medical procedures - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Bloating | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Confusion | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hypocalcemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Photosensitivity | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |