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 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
NCT ID:
NCT01870505
Description:
None
Frequency Threshold:
5
Time Frame:
2 years
Study:
NCT01870505
Study Brief:
BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast 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 |
|---|---|---|---|---|---|---|---|---|
| DOSE FINDING PHASE, Arm A, Cohort 0 | DOSE FINDING PHASE, Arm A, Cohort 0: BYL719 300mg PO, Letrozole 2.5mg PO | 0 | None | 1 | 4 | 4 | 4 | View |
| DOSE FINDING PHASE, Arm A, Cohort -1 | DOSE FINDING PHASE, Arm A, Cohort -1: BYL719 250 mg PO, Letrozole 2.5mg PO | 0 | None | 0 | 3 | 1 | 3 | View |
| DOSE FINDING PHASE, Arm B, Cohort 0 | DOSE FINDING PHASE, Arm B, Cohort 0: BYL719 300mg PO, Exemestane 25mg PO | 2 | None | 4 | 7 | 7 | 7 | View |
| Arm D | Arm D : Exemestane 25 mg PO + BYL719 MTD: 350mg PO | 0 | None | 2 | 10 | 10 | 10 | View |
| Dose Finding Phase, Arm C, Cohort 0 | Dose Finding Phase, Arm C, Cohort 0: Letrozole 2.5mg PO daily \& BYL719 250 mg 7days on and 7days off. | 1 | None | 3 | 6 | 6 | 6 | View |
| Dose Finding Phase, Arm C, Cohort 1 | Dose Finding Phase, Arm C, Cohort 1: Letrozole 2.5mg PO daily \& BYL719 300 mg 7days on and 7days off. | 0 | None | 2 | 6 | 6 | 6 | View |
| Dose Finding Phase, Arm D, Cohort 0 | Dose Finding Phase, Arm D, Cohort 0: Exemestane 25mg PO daily \& BYL719 250 mg 5days on and 2days off. | 0 | None | 0 | 3 | 0 | 3 | View |
| Dose Finding Phase, Arm D, Cohort 1 | Dose Finding Phase, Arm D, Cohort 1: Exemestane 25mg PO daily \& BYL719 300 mg 5days on and 2days off. | 0 | None | 1 | 6 | 6 | 6 | View |
| Dose Finding Phase, Arm D, Cohort 2 | Dose Finding Phase, Arm D, Cohort 2: Exemestane 25mg PO daily \& BYL719 350 mg 5days on and 2days off. | 1 | None | 2 | 7 | 7 | 7 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Death NOS | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Joint infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Renal and urinary disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Electrocardiogram QT corrected interval prolonged | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypermagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Renal and urinary disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hot flashes | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |