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 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
NCT ID:
NCT02609503
Description:
None
Frequency Threshold:
0
Time Frame:
From day 1 of treatment up to 40 weeks after the end of treatment
Study:
NCT02609503
Study Brief:
Pembrolizumab + Radiation for Locally Adv SCC of the Head and Neck (SCCHN) Not Eligible Cisplatin
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Pembrolizumab Concomitant With and Post 7 Weeks of Radiation | All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks. Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses. | 7 | None | 6 | 29 | 29 | 29 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (4.0) | View |
| Confusion | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Esophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Generalized muscle weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Weight loss | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Allergic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (4.0) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Blurred vision | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.0) | View |
| Bronchial infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Dysphasia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Ear and labyrinth disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (4.0) | View |
| Ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (4.0) | View |
| Edema limbs | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Eye disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.0) | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Flu like symptoms | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Gastroesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Hypercalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Hyperkalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypermagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypocalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypoglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypomagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (4.0) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Laryngeal edema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Laryngeal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Lymph node pain | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Lymphedema | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Memory impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Mucosal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Mucositis oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Oral pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Papulopustular rash | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Paresthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Respiratory, thoracic and mediastinal disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Salivary gland infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Skin and subcutaneous tissue disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Skin hyperpigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Sneezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Sore throat | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Surgical and medical procedures - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (4.0) | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (4.0) | View |
| Tooth infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Trismus | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Upper respiratory infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Voice alteration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Weight gain | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Weight loss | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| White blood cell decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Dermatitis radiation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Hoarseness | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Neck edema | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Nervous system disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Tracheal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |