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 @ 3:25 PM
Ignite Modification Date:
2025-12-25 @ 1:42 PM
NCT ID:
NCT03070392
Description:
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
Frequency Threshold:
5
Time Frame:
Approximately 36 months.
Study:
NCT03070392
Study Brief:
Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Tebentafusp | Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter. | 84 | None | 69 | 245 | 245 | 245 | View |
| Investigator's Choice | 1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity. | 57 | None | 26 | 111 | 102 | 111 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cytokine release syndrome | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 23.1 | View |
| Anorectal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Erysipelas | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Pneumonia mycoplasmal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Salmonella sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Amylase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Lipase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Tumor lysis syndrome | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Pathological fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Meningioma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | View |
| Metastases to abdominal cavity | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | View |
| Neoplasm progression | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | View |
| Tumor pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | View |
| Brain edema | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Intracranial mass | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Lethargy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Motor dysfunction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Spinal cord compression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Mental status changes | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.1 | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.1 | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.1 | View |
| Scrotal inflammation | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 23.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Pleurisy | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Pulmonary edema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Sleep apnea syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Rash papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Skin reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.1 | View |
| Left ventricular dysfunction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Hypopituitarism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 23.1 | View |
| Diplopia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23.1 | View |
| Periorbital edema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23.1 | View |
| Uveitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| General physical health deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Biliary obstruction | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.1 | View |
| Hepatic failure | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.1 | View |
| Hepatic necrosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.1 | View |
| Hepatic pain | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.1 | View |
| Hepatomegaly | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.1 | View |
| Hepatotoxicity | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.1 | View |
| Hyperbilirubinemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.1 | View |
| Hypertransaminasemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.1 | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Gait disturbance | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Anaphylactic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 23.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.1 | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.1 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Hyperthyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 23.1 | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 23.1 | View |
| Periorbital edema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Face edema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Edema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Hepatic pain | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.1 | View |
| Hyperbilirubinemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.1 | View |
| Cytokine release syndrome | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 23.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Blood lactate dehydrogenase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Lipase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Hypomagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Hypophosphatemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Parasthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Hair color changes | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Night sweats | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Skin exfoliation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Skin hyperpigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Skin hypopigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Vitiligo | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |