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 @ 9:49 PM
Ignite Modification Date: 2025-12-25 @ 7:27 PM
NCT ID: NCT00971932
Description: An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
Frequency Threshold: 5
Time Frame: Baseline until 30 days after last trial treatment.
Study: NCT00971932
Study Brief: Study of Cetuximab in Combination With Chemotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU) Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m\^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m\^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m\^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m\^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 \[AUC5\]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle. None None 12 33 33 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intracardiac mass NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Mechanical ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Esophageal fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Staphylococcal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
C-reactive protein increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypercreatininemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Cancer pain NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Neutrophilia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Dermatitis acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Rash generalized NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Pruritus generalized NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Skin fissures NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Skin chapped NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Pigmentation disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Cheilitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Anal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypochloremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypercreatininemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Injection site extravasation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Face edema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Injection site swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Hemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood albumin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Protein total decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood urea increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Paronychia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Hiccups NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Hemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Ventricular extrasystoles NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Nephropathy toxic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Renal impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Ocular hyperemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Orthostatic hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.0 View