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: 2025-12-25 @ 4:57 AM
Ignite Modification Date: 2025-12-26 @ 3:56 AM
NCT ID: NCT03448718
Description: None
Frequency Threshold: 0
Time Frame: All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Study: NCT03448718
Study Brief: Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Olaparib Monotherapy The starting dose of olaparib tablets will be dependent on the subject's calculated creatinine clearance (CrCl). Subjects with a CrCl of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day. Olaparib: 1 cycle = 28 days. Subject's with calculated creatinine clearance (CrCl) of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day. 13 None 11 19 18 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
HYPOXIA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
LUNG INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv4 View
PAIN NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
SEPSIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv4 View
STROKE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
URINARY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv4 View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
CONFUSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv4 View
EDEMA CEREBRAL NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
FEVER NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
THROMBOEMBOLIC EVENT NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv4 View
CREATININE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABDOMINAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
ALANINE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
ALKALINE PHOSPHATASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
ALLERGIC REACTION NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAEv4 View
ANAL MUCOSITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
ANEMIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv4 View
ANOREXIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv4 View
ASPARTATE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
BLADDER SPASM NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv4 View
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv4 View
BLOOD BILIRUBIN INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
CHEST PAIN - CARDIAC NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv4 View
CHOLESTEROL HIGH NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
CHRONIC KIDNEY DISEASE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv4 View
CONFUSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv4 View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
CREATININE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
DEPRESSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv4 View
DIARRHEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
DIZZINESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
DYSPEPSIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
DYSPHAGIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
DYSPNEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
EDEMA LIMBS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
ENDOCRINE DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAEv4 View
FACIAL PAIN NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
FALL NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAEv4 View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
FEVER NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
FLANK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
GASTROPARESIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
HEMATOMA NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv4 View
HEMATURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv4 View
HYPERGLYCEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
HYPERKALEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
HYPERTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv4 View
HYPOALBUMINEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
HYPOCALCEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
HYPOKALEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
HYPOMAGNESEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
HYPONATREMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
HYPOTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv4 View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv4 View
LETHARGY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
LEUKOCYTOSIS NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv4 View
LOCALIZED EDEMA NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
LYMPHOCYTE COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
MUCOSITIS ORAL NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
MYALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
NEUTROPHIL COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
PAIN NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
PAIN IN EXTREMITY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
PAPULOPUSTULAR RASH NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv4 View
PERIPHERAL SENSORY NEUROPATHY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
PLATELET COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
PRODUCTIVE COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
PROTEINURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv4 View
RASH MACULO-PAPULAR NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4 View
RENAL AND URINARY DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv4 View
REPRODUCTIVE SYSTEM AND BREAST DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAEv4 View
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
SINUS TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv4 View
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4 View
SORE THROAT NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
THROMBOEMBOLIC EVENT NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv4 View
URINARY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv4 View
URINARY TRACT OBSTRUCTION NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv4 View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
WHITE BLOOD CELL DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View