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 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
NCT ID:
NCT01088802
Description:
Adverse events were collected using the CTCAE guide to assign category, term, and grade.
Frequency Threshold:
5
Time Frame:
Up to 60 months after treatment
Study:
NCT01088802
Study Brief:
Treatment De-Intensification for Squamous Cell Carcinoma of the Oropharynx
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Dose De-escalating Radiation Therapy With Chemotherapy | This protocol combines selective radiation therapy dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) in patients with HPV-associated cancers of the oropharynx IMRT: Dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) Cisplatin: Cisplatin will be administered weekly for the first 3 weeks and the last 3 weeks of radiation. Patients will not receive chemotherapy during week 4 of treatment. Carboplatin: Carboplatin will be administered weekly during the 7 weeks of radiation. Carboplatin may be given as a substitution for cisplatin when cisplatin-related toxicities occur or when patients present with greater than grade 2 sensory or motor neuropathy, greater than 2 hearing loss, or less than 60 ml/min creatinine clearance. | 1 | None | 54 | 60 | 60 | 60 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| akathisia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| ANC decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| lower GI hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| lung infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| lung metastases | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | View |
| lymphocytes decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Metastatic carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | View |
| mucositis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| venous thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Voice changes | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| WBC Decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Xerostomia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| lymphocytes decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| colonic obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Esophageal stricture | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| general NOS: failure to thrive | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| hearing changes | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (4.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypomagnesia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| injury/procedure complication: bleeding at PEG site | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| injury/procedure complication: g-tube dysfunction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| injury/procedure complication: PEG dysfunction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| injury/procedure complication-NOS: admitted following left neck dissection | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| injury/procedure complication-NOS: PEG insertion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Mucous membrane | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| pain due to XRT | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| Pain NCI | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| pharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| psych NOS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| saliva/salivary gland | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Subcutaneous tissue | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| upper respiratory infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| vascular access complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| Neutrophils decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| PsychNOS: mood disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| WBC Decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| injury to carotid artery | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| dermal caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| subcutaneous tissue/RTOG | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (4.0) | View |
| trismus | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| voice changes/alteration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| lymphocytes decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| mucositis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| mucous membrane/RTOG | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| esophageal stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| esophagus/RTOG | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| hearing changes | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (4.0) | View |
| hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| ALT increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| AST increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| hypomagnesia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| larynx/RTOG | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| mucositis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| mucous membrane/RTOG | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| pain due to XRT | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| platelets/count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| saliva/salivary gland | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| skin acute | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| skin acute | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| skin late | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| watery eye | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.0) | View |
| WBC decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| xerostomia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| esophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| esophagus/RTOC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| hearing changes/impairment | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (4.0) | View |
| hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| hypomagnesia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| larynx/RTOG | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| pain due to XRT | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| salivary gland | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| skin acute | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| skin late | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| subcutaneous tissue | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (4.0) | View |
| voice changes | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| WBC decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| xerostomia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |