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 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:37 AM
NCT ID:
NCT00466960
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00466960
Study Brief:
Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous 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 |
|---|---|---|---|---|---|---|---|---|
| Treatment (Colony Stimulating Factor and Chemotherapy) | INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. sargramostim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV laboratory biomarker analysis: Correlative studies immunologic technique: Correlative studies | None | None | 2 | 21 | 20 | 21 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Allergic Reaction/Hypersensitivity (Including drug fever) | None | Immune system disorders | None | View |
| Tinnitus | None | Ear and labyrinth disorders | None | View |
| Low HCT | None | Blood and lymphatic system disorders | None | View |
| Hematocrit | None | Blood and lymphatic system disorders | None | View |
| Hemoglobin | None | Blood and lymphatic system disorders | None | View |
| Leukocytes (total WBC) | None | Blood and lymphatic system disorders | None | View |
| Neutrophils/granulocytes (ANC/AGC) | None | Blood and lymphatic system disorders | None | View |
| Hypertension | None | Cardiac disorders | None | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | None | General disorders | None | View |
| Rigors/Chills | None | General disorders | None | View |
| Weight Loss | None | General disorders | None | View |
| Constipation | None | Gastrointestinal disorders | None | View |
| Diarrhea | None | Gastrointestinal disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Edema:limb | None | Blood and lymphatic system disorders | None | View |
| Hypoalbuminemia | None | Metabolism and nutrition disorders | None | View |
| RBC | None | Blood and lymphatic system disorders | None | View |
| Lymphopenia | None | Blood and lymphatic system disorders | None | View |
| Platelets | None | Blood and lymphatic system disorders | None | View |
| Fatigue (asthenia, lethargy, malaise) | None | General disorders | None | View |
| Weight Gain | None | General disorders | None | View |
| Death not associated with CTCAE term | None | General disorders | None | View |
| Dry Skin | None | Skin and subcutaneous tissue disorders | None | View |
| Hair loss/alopecia (scalp or body) | None | Skin and subcutaneous tissue disorders | None | View |
| Injection site reaction/extravasation changes | None | Skin and subcutaneous tissue disorders | None | View |
| Nail Changes | None | Skin and subcutaneous tissue disorders | None | View |
| Rash: Acne/Acneiform | None | Skin and subcutaneous tissue disorders | None | View |
| Anorexia | None | Gastrointestinal disorders | None | View |
| Mucositis/stomatitis (functional/symptomatic) | None | Gastrointestinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Hypocalcemia | None | Metabolism and nutrition disorders | None | View |
| GFR | None | Metabolism and nutrition disorders | None | View |
| Low Protein | None | Metabolism and nutrition disorders | None | View |
| Hypokalemia | None | Metabolism and nutrition disorders | None | View |
| Hyponatremia | None | Metabolism and nutrition disorders | None | View |
| Memory Impairment | None | General disorders | None | View |
| Somnolence/depressed level of consciousness | None | General disorders | None | View |
| Arthralgia (Pain) | None | General disorders | None | View |
| Bone Pain | None | General disorders | None | View |
| Head pain/Headache | None | General disorders | None | View |
| Joint Pain | None | General disorders | None | View |
| Muscle Pain | None | General disorders | None | View |
| Myalgia (Pain) | None | General disorders | None | View |
| Dyspnea (shortness of breath) | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Urinary Retention (including neurogenic bladder) | None | Renal and urinary disorders | None | View |
| Flu-like syndrome | None | General disorders | None | View |