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 @ 4:25 PM
Ignite Modification Date:
2025-12-25 @ 2:19 PM
NCT ID:
NCT04220866
Description:
The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Frequency Threshold:
5
Time Frame:
Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.:
Study:
NCT04220866
Study Brief:
Study of Intratumoral (IT) Ulevostinag (MK-1454) in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (MK-1454-002)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Ulevostinag + Pembrolizumab | Participants received ulevostinag 540 ug via IT injection on Day 1 of every week for two 3-week cycles (Cycles 1-2), then on Day 1 of each 3-week cycle for up 33 cycles (Cycles 3-35), for a total of 35 cycles PLUS pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment was up to approximately 2 years. | 4 | None | 5 | 8 | 8 | 8 | View |
| Pembrolizumab | Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment is up to approximately 2 years. | 5 | None | 4 | 10 | 9 | 10 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Injection site ulcer | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Injection related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Wound haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Tumour haemorrhage | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| Carotid artery aneurysm | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pneumonitis aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Lymphadenitis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Tracheo-oesophageal fistula | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 25.1 | View |
| Hyperacusis | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 25.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 25.1 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 25.1 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Impaired gastric emptying | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Palatal disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Axillary pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Injection site necrosis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Swelling face | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Bacterial disease carrier | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Bacteriuria | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Candida infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Hepatitis C | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Pyuria | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Relapsing fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Soft tissue infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Tongue fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Stoma site discharge | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Vascular pseudoaneurysm | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Blood thyroid stimulating hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Tri-iodothyronine free increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hyperphosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Neoplasm swelling | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| Skin neoplasm bleeding | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| Tumour inflammation | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| Anosmia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Speech disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Nasal cavity mass | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Dermatitis acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Drug eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Sensitive skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Skin burning sensation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |