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 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
NCT ID:
NCT00665002
Description:
None
Frequency Threshold:
0
Time Frame:
4 years, 4 months
Study:
NCT00665002
Study Brief:
Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Myeloid Neoplasms
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Experimental: WT-1 Analog Peptide Vaccine | Participants received 6 bi-weekly vaccinations over 10 weeks. | None | None | 2 | 16 | 15 | 16 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Platelets - low | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Leukocytes (total WBC) - low | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Neutrophils/granulocytes (ANC/AGC) - low | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hemoglobin - low | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Bone marrow cellularity | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Injection site reaction/extravasation changes | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Dermatology/Skin - Other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Pruritus/itching | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash: erythema multiforme | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Hair loss/alopecia (scalp or body) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Rigors/chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Distension/bloating, abdominal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Gastrointestinal - Other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dry mouth/salivary gland (xerostomia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Mucositis/stomatitis (clinical exam) - Anus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Mucositis/stomatitis (clinical exam) - Oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Pain - Abdomen NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Other | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Bone | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Head/headache | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Joint | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Muscle | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Neck | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain - Sinus | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Glucose, serum-high (hyperglycemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Metabolic/Laboratory - Other | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Bilirubin (hyperbilirubinemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Potassium, serum-low (hypokalemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy: sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Mood alteration - Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Arthritis (non-septic) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) Whole body/generalized | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Dry eye syndrome | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Ocular/Visual - Other | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Renal/Genitourinary - Other | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Urinary frequency/urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (3.0) | View |
| Coagulation - Other | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Thrombotic microangiopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hot flashes/flushes | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (3.0) | View |
| Edema: limb | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Flu-like syndrome | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |