Adverse Events Module

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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 @ 1:37 PM
Ignite Modification Date: 2025-12-25 @ 12:36 PM
NCT ID: NCT01146795
Description: Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Frequency Threshold: 5
Time Frame: Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months).
Study: NCT01146795
Study Brief: Neoadjuvant Therapy for Ovarian 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
Carboplatin, Paclitaxel, and Bevacizumab Three 21 day cycles of carboplatin, paclitaxel, and bevacizumab. After 3 cycles of chemotherapy patients will be considered for surgical cytoreduction. After surgical cytoreduction all patients will receive an additional 6 cycles of chemotherapy (cycles 4-9) regardless of disease status at the time of exploration. Chemotherapy should be re-instituted within 6 weeks of the surgical procedure. 4 None 3 32 31 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Motor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mood alteration: Anxiety NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Voice alteration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Elevated AST/SGOT NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hemolysis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
INR increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
PTT increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sweating NON_SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Weight loss NON_SYSTEMATIC_ASSESSMENT General disorders None View
Rigors NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperpigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ear, nose and throat exam abnormal NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hot flashes NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Increased creatinine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urine incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Wound complication - non-infectious NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Joint pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection, other NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cytokine release syndrome NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Gait Abnormal NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Edema, limb NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Edema, trunk/genital NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Decreased hemoglobin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Decreased Leukocytes NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Decreased ANC NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Decreased ANC NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Decreased platelets NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hemorrhage, nasal NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Taste alteration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Heartburn NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flushing skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View