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 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 12:34 AM
NCT ID:
NCT03404960
Description:
The safety population consisted of all patients who received at least one dose of study treatment.
Frequency Threshold:
5
Time Frame:
Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first.
Study:
NCT03404960
Study Brief:
Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Niraparib + Nivolumab (Arm A) | Niraparib + Nivolumab: Niraparib 200mg PO daily on days 1-28 of each 28-day cycle. Nivolumab 480mg IV day 1 of each cycle. | 7 | None | 20 | 46 | 46 | 46 | View |
| Niraparib + Ipilimumab (Arm B) | Niraparib + Ipilimumab: Niraparib 200mg PO daily on days 1-21 of each 21-day cycle. Ipilimumab 3mg/kg IV day 1 of each cycle, for the first 4 cycles only. | 5 | None | 15 | 45 | 44 | 45 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 5.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 5.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 5.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 5.0 | View |
| Duodenal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 5.0 | View |
| Gastric hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 5.0 | View |
| Obstruction gastric | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 5.0 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 5.0 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 5.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 5.0 | View |
| Other: Acute cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE 5.0 | View |
| Biliary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 5.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 5.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 5.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 5.0 | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 5.0 | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 5.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 5.0 | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 5.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 5.0 | View |
| Other: Passing gallbladder obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 5.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | View |
| Pulmonary edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 5.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 5.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 5.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 5.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 5.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 5.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 5.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 5.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 5.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 5.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 5.0 | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 5.0 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 5.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 5.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 5.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 5.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 5.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 5.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 5.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 5.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| Thyroid stimulating hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 5.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 5.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 5.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 5.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 5.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 5.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 5.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 5.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 5.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 5.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 5.0 | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 5.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 5.0 | View |
| Other: Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 5.0 | View |
| Hot flashes | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 5.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 5.0 | View |