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 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
NCT ID:
NCT00972205
Description:
None
Frequency Threshold:
0
Time Frame:
18 months
Study:
NCT00972205
Study Brief:
Paclitaxel and CBT-1(Registered Trademark) to Treat Solid Tumors
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Paclitaxel and CBT-1 to Treat Solid Tumors | Patients will be treated with oral CBT-1 at a dose of 500 mg/m\^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed. Paclitaxel will be 135 mg/m\^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle. | None | None | 3 | 12 | 12 | 12 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infection (pneumonia)with normal absolute neutrophil count (ANC) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Other: SVC (Superior vena cava) Syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Pericardial Effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ALKALINE PHOSPHATASE | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| ALLERGIC REACTION | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (3.0) | View |
| ALLERGIC RHINITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| ALOPECIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| ALT/SGPT | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| ANOREXIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| AST/SGOT | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| ATAXIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| BICARBONATE, SERUM LOW | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| BILIRUBIN | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| BLURRED VISION | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| CONFUSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| CREATININE | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| DIARRHEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| DISTENTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| DRY MOUTH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| DYSPNEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| EDEMA, H&N | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| EDEMA, LIMB | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| FEVER | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| FLUSHING | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| HEARTBURN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| HEMOGLOBIN | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| HEMOGLOBINURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| HEMORRHAGE-GI, UPPER GI NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| HYPERCALCEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| HYPERGLYCEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| HYPERKALEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| HYPERPIGMENTATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| HYPERURICEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| HYPOALBUMINEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| HYPOCALCEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| HYPOGLYCEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| HYPOKALEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| HYPOMAGNESEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| HYPONATREMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| HYPOPHOSPHATEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| HYPOTHYROIDISM | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (3.0) | View |
| INFECTION, URINARY TRACT NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| INR | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| LEUKOCYTES | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| LYMPHOPENIA | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| MOOD ALTERATION-ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| MUCOSITIS (CLINICAL EXAM), ORAL CAVITY | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| NAIL CHANGES | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| NEUROPATHY-CRANIAL: CN-V MOTOR-JAW MUSCLES; SENSORY-FACIAL | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| NEUROPATHY-SENSORY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| NEUTROPHILS | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| OTHER: DYSURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| OTHER: INFECTION NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| OTHER: LDH | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| OTHER: PERFORATION NOS | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (3.0) | View |
| OTHER: PULMONARY STENOSIS NOS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| OTHER: RUQ PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| PAIN, THROAT/PHARYNX/LARYNX | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| PAIN NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| PAIN, ABD NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| PAIN, BACK | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| PAIN, CHEST/THORAX NOS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| PAIN, HEAD/HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| PAIN, JOINT | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| PAIN, MUSCLE | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| PAIN, RECTUM | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| PAIN, TUMOR | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | View |
| PLATELETS | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| PROTEINURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| PRURITIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| PTT | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| RIGORS/CHILLS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| TASTE ALTERATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| URINARY RETENTION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| VOICE CHANGES | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| HYPERMAGNESEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| MOOD ALTERATION, DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| OTHER: LYMPHEDEMA | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |