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 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
NCT ID:
NCT00071058
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00071058
Study Brief:
Surgery Plus Chemotherapy (Doxorubicin, Vincristine and Etoposide), Mitotane, and Tariquidar to Treat Adrenocortical 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 |
|---|---|---|---|---|---|---|---|---|
| Surgery Plus Chemothrapy | Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy. Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m\^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m\^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3. | None | None | 13 | 50 | 49 | 50 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Allergic reaction/hypersensitivity (including drug fever) | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCv2.0 | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Cardiac left ventricular function | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Cardiac-ischemia/infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Thrombosis/embolism | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Fatigue (lethargy, malaise, asthenia) | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Rigors/chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Diarrhea patients without colostomy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Dysphagia, esophagitis, odynophagia (painful swallowing) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Ileus (or neuroconstipation) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Infection without neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Abdominal pain or cramping | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| SGPT (ALT) (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCv2.0 | View |
| Catheter-related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Infection without neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Infection/Febrile Neutropenia-Other (Specify, vag. yeast infection) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv2.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypermagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv2.0 | View |
| Muscle weakness (not due to neuropathy) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Musculoskeletal-Other (Specify, fracture of L. fibula) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Ataxia (incoordination) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Dizziness/lightheadedness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Mood alteration-anxiety, agitation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Mood alteration-depression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Neurology-Other (Specify, largyngitis, voice hoarseness; neurology: Tinnitus L>R ) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Neuropathy - motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Neuropathy-sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv2.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv2.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv2.0 | View |
| Tearing (watery eyes) | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv2.0 | View |
| Vision-blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv2.0 | View |
| Vision-flashing lights/floaters | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCv2.0 | View |
| Abdominal pain or cramping | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Arthralgia (joint pain) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Chest pain (non-cardiac and non-pleuritic) | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Earache (otalgia) | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCv2.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv2.0 | View |
| Myalgia (muscle pain) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv2.0 | View |
| Pain-Other (Specify, Back Pain; Neck; Flank R; Pain in right rib ) | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Rectal or perirectal pain (proctalgia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv2.0 | View |
| Urinary frequency/urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv2.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv2.0 | View |
| Vaginitis (not due to infection) | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCv2.0 | View |
| Sexual/Reproductive Function-Other (Specify, Amenorrhea) | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCv2.0 | View |
| Dermatology/Skin-Other (Specify, Head Rash; pain: port problems, pain, redness ) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Gastrointestinal-Other (Specify, dental extraction; early satiety; bloating) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Nail changes | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Pigmentation changes (e.g., vitiligo) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Hot flashes/flushes | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCv2.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Bilirubin | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCv2.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCv2.0 | View |
| SGOT (AST) (serum glutamic oxaloacetic transaminase) | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCv2.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Allergic reaction/hypersensitivity (including drug fever) | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCv2.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Rigors, chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Sweating (diaphoresis) | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Bruising (in absence of grade 3 or 4 thrombocytopenia) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Hand-foot skin reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv2.0 | View |
| Diarrhea patients without colostomy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Dyspepsia/heartburn | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Dysphagia, esophagitis, odynophagia (painful swallowing) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Ileus (or neuroconstipation) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Taste disturbance (dysgeusia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv2.0 | View |
| Hematuria (in the absence of vaginal bleeding) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Vaginal bleeding | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCv2.0 | View |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCv2.0 | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Vasovagal episode | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Cardiac left ventricular function | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Edema | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Peripheral arterial ischemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Thrombosis/embolism | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv2.0 | View |
| Prothrombin time (PT) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv2.0 | View |
| Fatigue (lethargy, malaise, asthenia) | SYSTEMATIC_ASSESSMENT | General disorders | CTCv2.0 | View |