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 @ 3:01 PM
Ignite Modification Date:
2025-12-25 @ 1:25 PM
NCT ID:
NCT00309959
Description:
None
Frequency Threshold:
0
Time Frame:
Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Study:
NCT00309959
Study Brief:
ABI-007 in Treating Patients With Persistent or Recurrent Cervical 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 |
|---|---|---|---|---|---|---|---|---|
| ABI-007 | ABI-007 125 mg/m2 IV weekly on day 1, 8, and 15 every 28 days (one cycle) until disease progression or adverse effects prohibit further therapy | None | None | 17 | 35 | 34 | 35 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Death No Ctcae Term - Death Nos | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Mucositis (Clinical Exam) - Oral Cavity | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Prolapse Of Stoma, Gi | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, Gi - Rectum | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Infection with Normal Or Grade 1 Or 2 Absolute Neutrophil Count: Blood | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf W/Nml Or Gr 1 Or 2 Anc: Wound | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Edema: Limb | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Creatinine | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Gait/Walking | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Neurology - Other | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Pain: Extremity-Limb | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain: Back | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Nausea/vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Other gastrointestinal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| GU | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Neurotoxicity | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pulmonary | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Constitutional (Fatigue) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Metabolic | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Dermatologic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Musculoskeletal | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Auditory | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (3.0) | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| SGOT | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Alkaline phosphatase | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| Lymphatics | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |