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 @ 4:48 AM
Ignite Modification Date: 2025-12-26 @ 3:50 AM
NCT ID: NCT03557918
Description: The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Frequency Threshold: 0
Time Frame: All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months.
Study: NCT03557918
Study Brief: Trial of Tremelimumab in Patients With Previously Treated Metastatic Urothelial 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
Tremelimumab Tremelimumab 750 mg IV Day 1 of each 28 day cycle. Up to 7 cycles. Tremelimumab: Tremelimumab 750 mg IV on Day 1 of each 28 day cycle; up to 7 cycles. Subjects that complete all initial 7 cycles but later progress during follow up may receive an additional 7 cycles of tremelimumab providing they meet eligibility criteria. 19 None 14 26 22 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ACUTE KIDNEY INJURY NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv4 View
ALANINE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
COLITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
COLONIC OBSTRUCTION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
CREATININE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
DIARRHEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
ENCEPHALOPATHY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
HEPATIC FAILURE NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAEv4 View
HYPERGLYCEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
ILEAL OBSTRUCTION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
INVESTIGATIONS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
MULTI-ORGAN FAILURE NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
PAIN NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
PULMONARY EDEMA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
RASH MACULO-PAPULAR NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue 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
THROMBOEMBOLIC EVENT NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv4 View
URINARY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv4 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ADRENAL INSUFFICIENCY NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAEv4 View
ALANINE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
ALKALINE PHOSPHATASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations 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
ARTHRALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
ASPARTATE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
BRUISING NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAEv4 View
CHILLS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
COLITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
CREATININE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
DELIRIUM NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders 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
DRY MOUTH NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
DRY SKIN NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4 View
DYSGEUSIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
DYSPNEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal 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
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
HEMATURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv4 View
HOARSENESS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
HOT FLASHES NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv4 View
HYPERCALCEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition 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
HYPERTHYROIDISM NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAEv4 View
HYPOALBUMINEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
HYPOCALCEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
HYPOGLYCEMIA 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
LIPASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
LYMPHOCYTE COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4 View
MUCOSITIS ORAL NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
MUSCLE WEAKNESS LOWER LIMB NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4 View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4 View
NEUTROPHIL COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
PAIN NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4 View
PALPITATIONS NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv4 View
PAPULOPUSTULAR RASH NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv4 View
PELVIC PAIN NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAEv4 View
PLATELET COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
PROTEINURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv4 View
PRURITUS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4 View
RASH ACNEIFORM NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue 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
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4 View
SERUM AMYLASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations 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
THROMBOEMBOLIC EVENT NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv4 View
URINARY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv4 View
URTICARIA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4 View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4 View
WEIGHT LOSS NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View
WHITE BLOOD CELL DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4 View