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 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:30 PM
NCT ID:
NCT00645593
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00645593
Study Brief:
Study of Gemcitabine and Cisplatin With or Without Cetuximab in 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 |
|---|---|---|---|---|---|---|---|---|
| Arm 2, Cetuximab, Gemcitabine and Cisplatin | Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days. | None | None | 36 | 60 | 60 | 60 | View |
| Arm 1, Gemcitabine and Cisplatin | Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days. | None | None | 16 | 29 | 29 | 29 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| CNS cerebrovascular ischemia | None | Vascular disorders | None | View |
| Confusion | None | Nervous system disorders | None | View |
| Dehydration | None | Metabolism and nutrition disorders | None | View |
| Febrile neutropenia (fever of unknown origin without documented infection) | None | General disorders | None | View |
| Hemorrhage, GI | None | Gastrointestinal disorders | None | View |
| Hypertension | None | Cardiac disorders | None | View |
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | None | Infections and infestations | None | View |
| Infection - Other | None | Infections and infestations | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils | None | Infections and infestations | None | View |
| Leukocytes (total WBC) | None | Investigations | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Neurology - Other | None | Nervous system disorders | None | View |
| Neutrophils/granulocytes (ANC/AGC) | None | Investigations | None | View |
| Pain | None | General disorders | None | View |
| Platelets | None | Investigations | None | View |
| Pneumonitis/pulmonary infiltrates | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Renal failure | None | Renal and urinary disorders | None | View |
| Supraventricular and nodal arrhythmia | None | Cardiac disorders | None | View |
| Thrombosis/thrombus/embolism | None | Vascular disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | None | Investigations | None | View |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | None | Investigations | None | View |
| Allergic reaction/hypersensitivity (including drug fever) | None | Immune system disorders | None | View |
| Anorexia | None | Metabolism and nutrition disorders | None | View |
| Ataxia (incoordination) | None | Nervous system disorders | None | View |
| Cardiac General - Other | None | Cardiac disorders | None | View |
| Cognitive disturbance | None | Nervous system disorders | None | View |
| Colitis, infectious (e.g., Clostridium difficile) | None | Gastrointestinal disorders | None | View |
| Confusion | None | Nervous system disorders | None | View |
| Death not associated with CTCAE term | None | General disorders | None | View |
| Dizziness | None | Nervous system disorders | None | View |
| Dysphagia (difficulty swallowing) | None | Gastrointestinal disorders | None | View |
| Edema: limb | None | General disorders | None | View |
| Fatigue (asthenia, lethargy, malaise) | None | General disorders | None | View |
| Fever (in the absence of neutropenia) | None | General disorders | None | View |
| Fracture | None | Musculoskeletal and connective tissue disorders | None | View |
| Anemia | None | Blood and lymphatic system disorders | None | View |
| Hemorrhage, GU | None | Renal and urinary disorders | None | View |
| Infection with unknown ANC | None | Infections and infestations | None | View |
| Insomnia | None | Nervous system disorders | None | View |
| Magnesium, serum-low (hypomagnesemia) | None | Metabolism and nutrition disorders | None | View |
| Memory impairment | None | Nervous system disorders | None | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) | None | Musculoskeletal and connective tissue disorders | None | View |
| Neuropathy: motor | None | Nervous system disorders | None | View |
| Neuropathy: sensory | None | Nervous system disorders | None | View |
| Obstruction, GI | None | Gastrointestinal disorders | None | View |
| Obstruction, GU | None | Renal and urinary disorders | None | View |
| Peripheral arterial ischemia | None | Vascular disorders | None | View |
| Pulmonary/Upper Respiratory - Other (Specify) | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Rash: acne/acneiform | None | Skin and subcutaneous tissue disorders | None | View |
| Sodium, serum-low (hyponatremia) | None | Metabolism and nutrition disorders | None | View |
| Syncope (fainting) | None | Nervous system disorders | None | View |
| Thrombosis/embolism (vascular access-related) | None | Vascular disorders | None | View |
| Typhlitis (cecal inflammation) | None | Gastrointestinal disorders | None | View |
| Ulcer, GI | None | Gastrointestinal disorders | None | View |
| Ulceration | None | Skin and subcutaneous tissue disorders | None | View |
| Urinary retention (including neurogenic bladder) | None | Renal and urinary disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Albumin, serum-low (hypoalbuminemia) | None | Investigations | None | View |
| Anorexia | None | Metabolism and nutrition disorders | None | View |
| Constipation | None | Gastrointestinal disorders | None | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Creatinine | None | Investigations | None | View |
| Dehydration | None | Metabolism and nutrition disorders | None | View |
| Diarrhea | None | Gastrointestinal disorders | None | View |
| Dizziness | None | Nervous system disorders | None | View |
| Dyspnea (shortness of breath) | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Fatigue (asthenia, lethargy, malaise) | None | General disorders | None | View |
| Glucose, serum-high (hyperglycemia) | None | Metabolism and nutrition disorders | None | View |
| Hair loss/alopecia (scalp or body) | None | Skin and subcutaneous tissue disorders | None | View |
| Anemia | None | Blood and lymphatic system disorders | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils | None | Infections and infestations | None | View |
| Leukocytes (total WBC) | None | Investigations | None | View |
| Lymphopenia | None | Investigations | None | View |
| Magnesium, serum-low (hypomagnesemia) | None | Metabolism and nutrition disorders | None | View |
| Mood alteration | None | Nervous system disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Neuropathy: sensory | None | Nervous system disorders | None | View |
| Neutrophils/granulocytes (ANC/AGC) | None | Investigations | None | View |
| Pain | None | General disorders | None | View |
| Pain - Other | None | General disorders | None | View |
| Platelets | None | Investigations | None | View |
| Potassium, serum-high (hyperkalemia) | None | Metabolism and nutrition disorders | None | View |
| Sodium, serum-low (hyponatremia) | None | Metabolism and nutrition disorders | None | View |
| Taste alteration (dysgeusia) | None | Gastrointestinal disorders | None | View |
| Tinnitus | None | Ear and labyrinth disorders | None | View |
| Urinary frequency/urgency | None | Renal and urinary disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | None | Investigations | None | View |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | None | Investigations | None | View |
| Alkaline phosphatase | None | Investigations | None | View |
| Allergic reaction/hypersensitivity (including drug fever) | None | Immune system disorders | None | View |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | None | Immune system disorders | None | View |
| Calcium, serum-low (hypocalcemia) | None | Metabolism and nutrition disorders | None | View |
| Dehydration | None | Metabolism and nutrition disorders | None | View |
| Dermatology/Skin - Other (Specify) | None | Skin and subcutaneous tissue disorders | None | View |
| Dry skin | None | Skin and subcutaneous tissue disorders | None | View |
| Edema: limb | None | General disorders | None | View |
| Fever (in the absence of neutropenia) | None | General disorders | None | View |
| Heartburn/dyspepsia | None | Gastrointestinal disorders | None | View |
| Hemorrhage, GU | None | Renal and urinary disorders | None | View |
| Hemorrhage, pulmonary/upper respiratory | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypertension | None | Cardiac disorders | None | View |
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | None | Infections and infestations | None | View |
| Infection - Other | None | Infections and infestations | None | View |
| Infection with unknown ANC | None | Infections and infestations | None | View |
| Insomnia | None | Nervous system disorders | None | View |
| Magnesium, serum-high (hypermagnesemia) | None | Metabolism and nutrition disorders | None | View |
| Mucositis/stomatitis (clinical exam) | None | Gastrointestinal disorders | None | View |
| Mucositis/stomatitis (functional/symptomatic) | None | Gastrointestinal disorders | None | View |
| Muscle weakness, generalized or specific area (not due to neuropathy) | None | Musculoskeletal and connective tissue disorders | None | View |
| Nail changes | None | Skin and subcutaneous tissue disorders | None | View |
| Pruritus/itching | None | Skin and subcutaneous tissue disorders | None | View |
| Rash/desquamation | None | Skin and subcutaneous tissue disorders | None | View |
| Rash: acne/acneiform | None | Skin and subcutaneous tissue disorders | None | View |
| Rigors/chills | None | General disorders | None | View |
| Sodium, serum-high (hypernatremia) | None | Metabolism and nutrition disorders | None | View |
| Sodium, serum-low (hyponatremia) | None | Metabolism and nutrition disorders | None | View |
| Supraventricular and nodal arrhythmia | None | Cardiac disorders | None | View |
| Thrombosis/embolism (vascular access-related) | None | Vascular disorders | None | View |
| Thrombosis/thrombus/embolism | None | Vascular disorders | None | View |
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Weight loss | None | Investigations | None | View |