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 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
NCT ID:
NCT01578551
Description:
None
Frequency Threshold:
0
Time Frame:
up to 1 year
Study:
NCT01578551
Study Brief:
Study of Metformin Plus Paclitaxel/Carboplatin/Bevacizumab in Patients With Adenocarcinoma.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm A | Metformin starting at a dose of 500 mg twice a day, orally with meals. After one week, increase the dose of metformin to 1000 mg as the first dose of the day and 500 mg as the second dose. After another week, increase to 1000 mg of metformin two times a day. Metformin treatment will be initiated one week before beginning chemotherapy, if possible, but chemotherapy will not be delayed for metformin loading. Paclitaxel: 200 mg/m² IV over 3 hours, day 1 of each cycle. Carboplatin: Carboplatin is administered at AUC= 6 mg/ml X min IV over 15-30 minutes, immediately following Paclitaxel infusion every 21 days Bevacizumab: 15 mg/kg every 21 days, Metformin: 1000 mg twice daily with food. | 0 | None | 1 | 19 | 19 | 19 | View |
| Arm B | Paclitaxel: 200 mg/m² IV over 3 hours, day 1 of each cycle. Carboplatin: Carboplatin is administered at AUC= 6 mg/ml X min IV over 15-30 minutes, immediately following Paclitaxel infusion every 21 days Paclitaxel + Carboplatin + Bevacizumab will be administered once every 21 days (Day 1) for up to 6 cycles. If subject has complete response, partial response, stable disease, or unacceptable toxicity. Bevacizumab with Metformin (Arm A) or Bevacizumab alone (Arm B) may continue as maintenance therapy Bevacizumab: All patients will receive the drug at 15 mg/kg every 21 days, given immediately after completion of chemotherapy, starting with Cycle 1. After induction chemotherapy is completed (4 cycles), bevacizumab will continue at 15 mg/kg every 21 days until PD (provided neither PD nor toxicity requiring discontinuation has occurred) measured from date of first dose of bevacizumab. | 0 | None | 0 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Colonic perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Catheter-related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Neuropathy | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Thomboembolic event | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |