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 @ 2:54 PM
Ignite Modification Date:
2025-12-25 @ 1:20 PM
NCT ID:
NCT03338959
Description:
Subjects with an Adverse Event (AE) of Grade \>1 will be followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-neoplastic therapy, whichever occurs first. Serious Adverse Events (SAEs) that occur within 90 days of the last dose of pembrolizumab or 30 days following cessation of pembrolizumab if the participant initiates a new anticancer therapy - whichever is earlier should also be followed and recorded.
Frequency Threshold:
0
Time Frame:
All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months)
Study:
NCT03338959
Study Brief:
Pembrolizumab and Radiation Therapy in Treating Patients With Intermediate or High-Grade Soft Tissue Sarcoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Treatment (Pembrolizumab, Radiation Therapy) | Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for 3 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy daily for 5-6 weeks. Pembrolizumab: Given IV Radiation Therapy: Undergo radiation therapy | 0 | None | 5 | 27 | 17 | 27 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Colonic perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Gastrointestinal disorders - Other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Hallucinations | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Peripheral ischemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Wound dehiscence | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Dermatitis Radiation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Wound dehiscence | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Tumor Pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (5.0) | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Dermatitis Radiation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Dry Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Edema Limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Muscle cramp | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Thyroid stimulating hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Localized edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Esophageal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Rectal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Bruising | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Seroma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (5.0) | View |
| Apnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Phemothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Rhinorrhea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Buttock pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Chest wall pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Musculoskeletal and connective tissue disorder - Other | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Investigations - Other | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Gum infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Vaginal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Urinary urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (5.0) | View |
| Pelvic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (5.0) | View |
| Vaginal hemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (5.0) | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (5.0) | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Bullous dermtitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Skin and subcutaneous tissue disorders - Other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Phantom pain | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Allergic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (5.0) | View |