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 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
NCT ID:
NCT00138151
Description:
None
Frequency Threshold:
5
Time Frame:
8 years
Study:
NCT00138151
Study Brief:
Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent 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 |
|---|---|---|---|---|---|---|---|---|
| Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b | * Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle * Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle * Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days | None | None | 18 | 33 | 30 | 33 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Edema | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Infection without neutropenia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Thrombosis/embolism | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Fever in the absence of neutropenia where neutropenia is defined as AGC <1.0 x 10e9/L | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Pneumonitis/pulmonary infiltrates | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Fistula or GU fistula (e.g., vaginal, vesicovaginal) | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Ureteral obstruction | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Hemoglobin | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Depressed level of consciousness - somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Vaginal bleeding | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Hyperkalemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Muscle weakness (not due to neuropathy) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Pain (other) - back pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Congestive heart failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Dypsnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Infection/Febrile Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Pulmonary other - respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Hypocalcemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Mood alteration - anxiety, agitation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (2.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Hematuria (in the absence of vaginal bleeding) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Elevated ammonia level | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Hypomagnesemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Fracture - neck | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Cervical spinal cord compression | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Change in mental status | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Hallucinations | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (2.0) | View |
| Rectal bleeding/hematochezia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Rigors/chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Dermatology/Skin-Other (Specify,_____) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Nail changes | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Hypertriglyceridemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Hypercholesterolemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Infection without neutropenia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Diarrhea, patients without colostomy | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Gastrointestinal - other | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Fatigue (lethargy, malaise, asthenia) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Rigors, chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Constitutional Symptoms-Other (Specify,_____) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Pain-Other (Specify,___) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Abdominal pain or cramping | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Myalgia (muscle pain) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Arthralgia (joint pain) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Rash/desquamation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Hemoglobin | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Neutrophils/granulocytes (ANC/AGC) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Leukocytes (total WBC) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Blood/Bone Marrow-Other (Specify,_____) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Neuropathy-sensory | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Mood alteration-anxiety, agitation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (2.0) | View |
| Mood alteration-depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (2.0) | View |
| Dizziness/lightheadedness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Neurology-Other (Specify,______) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Renal/Genitourinary-Other (Specify,____) | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Urinary frequency/urgency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Dysuria (painful urination) | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Ureteral obstruction | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Hyperuricemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (2.0) | View |
| Edema | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Muscle weakness (not due to neuropathy) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Musculoskeletal-Other (Specify,______) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Dyspnea (shortness of breath) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Infection/Febrile Neutropenia-Other (Specify,____) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (2.0) | View |
| Hot flashes/flushes | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (2.0) | View |