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 @ 3:37 PM
Ignite Modification Date:
2025-12-25 @ 1:49 PM
NCT ID:
NCT00101192
Description:
All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Frequency Threshold:
0
Time Frame:
from study entry up to 5 years
Study:
NCT00101192
Study Brief:
Cetuximab and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical 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 |
|---|---|---|---|---|---|---|---|---|
| Cetuximab | Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy. | None | None | 33 | 69 | 66 | 69 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Death No Ctcae Term - Disease Progression Nos | None | General disorders | CTCAE (3.0) | View |
| Fistula, Gi - Ileum | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Obstruction, Gi - Colon | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Obstruction, Gi - Small Bowel Nos | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Perforation, Gi - Small Bowel Nos | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Vomiting | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Nausea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, Gu - Vagina | None | Vascular disorders | CTCAE (3.0) | View |
| Hemorrhage/Bleeding - Other | None | Vascular disorders | CTCAE (3.0) | View |
| Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos | None | Infections and infestations | CTCAE (3.0) | View |
| Opportunisitic Inf Assoc. W/Gr 2 Lymphopenia | None | Infections and infestations | CTCAE (3.0) | View |
| Inf W/Nml Or Gr 1 Or 2 Anc: Kidney | None | Infections and infestations | CTCAE (3.0) | View |
| Inf W/Nml Or Gr 1 Or 2 Anc: Bladder | None | Infections and infestations | CTCAE (3.0) | View |
| Creatinine | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Ggt | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypomagnesemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Pain - Other | None | General disorders | CTCAE (3.0) | View |
| Pain: Extremity-Limb | None | General disorders | CTCAE (3.0) | View |
| Pain: Muscle | None | General disorders | CTCAE (3.0) | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Obstruction, Gu - Urethra | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Obstruction, Gu - Ureter | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Fistula, Gu - Vagina | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Renal Failure | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Thrombosis/Thrombus/Embolism | None | Vascular disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hemorrhage/Pulmonary - Nose | None | Vascular disorders | CTCAE (3.0) | View |
| Hemorrhage, Gi - Oral Cavity | None | Vascular disorders | CTCAE (3.0) | View |
| Hemorrhage, Gu - Bladder | None | Vascular disorders | CTCAE (3.0) | View |
| Hemorrhage, Gi - Abdomen Nos | None | Vascular disorders | CTCAE (3.0) | View |
| Petechiae | None | Vascular disorders | CTCAE (3.0) | View |
| Inf W/Nml Or Gr 1 Or 2 Anc: Uterus | None | Infections and infestations | CTCAE (3.0) | View |
| Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) | None | Infections and infestations | CTCAE (3.0) | View |
| Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) | None | Infections and infestations | CTCAE (3.0) | View |
| Inf Unknown Anc: Lung (Pneumonia) | None | Infections and infestations | CTCAE (3.0) | View |
| Inf Unknown Anc: Nose | None | Infections and infestations | CTCAE (3.0) | View |
| Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos | None | Infections and infestations | CTCAE (3.0) | View |
| Infection - Other | None | Infections and infestations | CTCAE (3.0) | View |
| Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus | None | Infections and infestations | CTCAE (3.0) | View |
| Inf W/Nml Or Gr 1 Or 2 Anc: Vagina | None | Infections and infestations | CTCAE (3.0) | View |
| Inf W/Nml Or Gr 1 Or 2 Anc: Sinus | None | Infections and infestations | CTCAE (3.0) | View |
| Inf Unknown Anc: Urinary Tract Nos | None | Infections and infestations | CTCAE (3.0) | View |
| Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia) | None | Infections and infestations | CTCAE (3.0) | View |
| Inf W/Nml Or Gr 1 Or 2 Anc: Bladder | None | Infections and infestations | CTCAE (3.0) | View |
| Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos | None | Infections and infestations | CTCAE (3.0) | View |
| Edema: Limb | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Ast | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Metabolic/Laboratory - Other | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Cholesterol,serum High | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Proteinuria | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Creatinine | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypoalbuminemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Ggt | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Alt | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Alkaline Phosphatase | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Bilirubin | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypermagnesemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypophosphatemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hyponatremia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Cpk | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Bicarbonate, Serum-Low | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Amylase | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypernatremia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypocalcemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hyperkalemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hyperglycemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypokalemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypoglycemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypercalcemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypomagnesemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Myositis | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Osteoporosis | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Fracture | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Extremity-Upper (Function) | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Gait/Walking | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Arthritis | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Muscle Weakness - Whole Body/Generalized | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Muscle Weakness - Left-Sided | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Muscle Weakness - Extremity-Lower | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pyramidal Tract Dysfunction | None | Nervous system disorders | CTCAE (3.0) | View |
| Mood Alteration - Depression | None | Nervous system disorders | CTCAE (3.0) | View |
| Mood Alteration - Anxiety | None | Nervous system disorders | CTCAE (3.0) | View |
| Tremor | None | Nervous system disorders | CTCAE (3.0) | View |
| Confusion | None | Nervous system disorders | CTCAE (3.0) | View |
| Dizziness | None | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy,cranial - Cn Xii Motor-Tongue | None | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy,cranial - Cn Ix Motor-Pharynx | None | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy-Sensory | None | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy-Motor | None | Nervous system disorders | CTCAE (3.0) | View |
| Dry Eye | None | Eye disorders | CTCAE (3.0) | View |
| Flashing Lights/Floaters | None | Eye disorders | CTCAE (3.0) | View |
| Blurred Vision | None | Eye disorders | CTCAE (3.0) | View |
| Pain - Other | None | General disorders | CTCAE (3.0) | View |
| Pain: Pelvis | None | General disorders | CTCAE (3.0) | View |
| Pain: Breast | None | General disorders | CTCAE (3.0) | View |
| Pain: Vagina | None | General disorders | CTCAE (3.0) | View |
| Pain: Chest /Thorax Nos | None | General disorders | CTCAE (3.0) | View |
| Pain: Chest Wall | None | General disorders | CTCAE (3.0) | View |
| Pain: Throat/Pharynx/Larynx | None | General disorders | CTCAE (3.0) | View |
| Pain: Head/Headache | None | General disorders | CTCAE (3.0) | View |
| Pain: Neck | None | General disorders | CTCAE (3.0) | View |
| Pain: Extremity-Limb | None | General disorders | CTCAE (3.0) | View |
| Pain: Buttock | None | General disorders | CTCAE (3.0) | View |
| Pain: Back | None | General disorders | CTCAE (3.0) | View |
| Pain: Joint | None | General disorders | CTCAE (3.0) | View |
| Pain: Bone | None | General disorders | CTCAE (3.0) | View |
| Pain: Kidney | None | General disorders | CTCAE (3.0) | View |
| Pain: Bladder | None | General disorders | CTCAE (3.0) | View |
| Pain: Stomach | None | General disorders | CTCAE (3.0) | View |
| Pain: Rectum | None | General disorders | CTCAE (3.0) | View |
| Pain: Oral Cavity | None | General disorders | CTCAE (3.0) | View |
| Pain: Esophagus | None | General disorders | CTCAE (3.0) | View |
| Pain: Dental/Teeth/Peridontal | None | General disorders | CTCAE (3.0) | View |
| Pain: Abdominal Pain Nos | None | General disorders | CTCAE (3.0) | View |
| Pain: Skin | None | General disorders | CTCAE (3.0) | View |
| Pain: Tumor | None | General disorders | CTCAE (3.0) | View |
| Pain: Muscle | None | General disorders | CTCAE (3.0) | View |
| Pain: Neuralgia | None | General disorders | CTCAE (3.0) | View |
| Pulmonary: Other | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Airway Obstruction - Bronchus | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Nasal/Paranasal Reactions | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Voice Changes | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Renal/Genitourinary - Other | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Leak, Gu - Vagina | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Cystitis | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Urinary Retention | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Obstruction, Gu - Ureter | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Incontinence, Urinary | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Fistula, Gu - Vagina | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Fistula, Gu - Bladder | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Bladder Spasm | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Renal Failure | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Urinary Frequency | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Vaginal Discharge | None | Reproductive system and breast disorders | CTCAE (3.0) | View |
| Flu-Like Syndrome | None | General disorders | CTCAE (3.0) | View |
| Thrombosis/Thrombus/Embolism | None | Vascular disorders | CTCAE (3.0) | View |
| Phlebitis | None | Vascular disorders | CTCAE (3.0) | View |
| Taste Alteration | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dry Mouth | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Mucositis (Functional/Sympt) - Oral Cavity | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Stricture, Gi - Colon | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Obstruction, Gi - Small Bowel Nos | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Mucositis (Clinical Exam) - Oral Cavity | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Vomiting | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Anorexia | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dehydration | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Constipation | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Nausea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Gastrointestinal - Other | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, Gu - Urinary Nos | None | Vascular disorders | CTCAE (3.0) | View |
| Hemorrhage, Gu - Vagina | None | Vascular disorders | CTCAE (3.0) | View |
| Sweating | None | General disorders | CTCAE (3.0) | View |
| Fever | None | General disorders | CTCAE (3.0) | View |
| Weight Loss | None | General disorders | CTCAE (3.0) | View |
| Rigors/Chills | None | General disorders | CTCAE (3.0) | View |
| Fatigue | None | General disorders | CTCAE (3.0) | View |
| Insomnia | None | General disorders | CTCAE (3.0) | View |
| Nail Changes | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Hair Loss/Alopecia (Scalp Or Body) | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Wound Complication, Non-Infectious | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Acne | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Rash | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Dry Skin | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Decubitus | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Burn | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Flushing | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Hand-Foot | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Hot Flashes | None | Endocrine disorders | CTCAE (3.0) | View |
| Masculinization Of Female | None | Endocrine disorders | CTCAE (3.0) | View |
| Fistula, Gi - Rectum | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Gastritis | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Heartburn | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dental: Teeth | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Ileus | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dysphagia | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Distention | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, Gi - Rectum | None | Vascular disorders | CTCAE (3.0) | View |
| Hemorrhage, Gu - Ovary | None | Vascular disorders | CTCAE (3.0) | View |
| Neutrophils | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Platelets | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Leukocytes | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hemolysis | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hemoglobin | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| S/N Arrhythmia: Atrial Fibrillation | None | Cardiac disorders | CTCAE (3.0) | View |
| Palpitations | None | Cardiac disorders | CTCAE (3.0) | View |
| S/N Arrhythmia: Sinus Tachycardia | None | Cardiac disorders | CTCAE (3.0) | View |
| S/N Arrhythmia: Atrial Tachycardia | None | Cardiac disorders | CTCAE (3.0) | View |
| Hypertension | None | Cardiac disorders | CTCAE (3.0) | View |
| Hypotension | None | Cardiac disorders | CTCAE (3.0) | View |
| Cardipulmonary Arrest | None | Cardiac disorders | CTCAE (3.0) | View |
| Inr | None | Vascular disorders | CTCAE (3.0) | View |
| Fibrinogen | None | Vascular disorders | CTCAE (3.0) | View |
| Ptt | None | Vascular disorders | CTCAE (3.0) | View |
| Allergic Reaction/Hypersensitivity | None | Immune system disorders | CTCAE (3.0) | View |
| Otitis Middle Ear | None | Ear and labyrinth disorders | CTCAE (3.0) | View |
| Tinnitus | None | Ear and labyrinth disorders | CTCAE (3.0) | View |
| Hearing (Monitoring Program) | None | Ear and labyrinth disorders | CTCAE (3.0) | View |