Adverse Events Module

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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 @ 11:18 PM
Ignite Modification Date: 2025-12-25 @ 8:57 PM
NCT ID: NCT00084656
Description: None
Frequency Threshold: 5
Time Frame: From first dose to 70 days post last dose (up to 3 years)
Study: NCT00084656
Study Brief: Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV 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
3.0 MG/KG IPILIMUMAB + PEPTIDES HLA-A\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions. Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations. 0 None 5 25 25 25 View
10 MG/KG IPILIMUMAB + PEPTIDES HLA-A\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions. Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations. 0 None 7 25 25 25 View
10 MG/KG IPILIMUMAB HLA-A\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions. 0 None 10 26 25 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders 13.0 View
Hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders 13.0 View
Hypopituitarism SYSTEMATIC_ASSESSMENT Endocrine disorders 13.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders 13.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Diarrhoea haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Duodenitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Gastrointestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Megacolon SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Hernia obstructive SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Autoimmune hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 13.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 13.0 View
Blood corticotrophin decreased SYSTEMATIC_ASSESSMENT Investigations 13.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 13.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 13.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 13.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 13.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 13.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 13.0 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders 13.0 View
Cerebral ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders 13.0 View
Azotaemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders 13.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 13.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders 13.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Injection site rash SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Injection site vesicles SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Irritability SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders 13.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations 13.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations 13.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations 13.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 13.0 View
Libido decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders 13.0 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders 13.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 13.0 View
Lymph node pain SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 13.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 13.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders 13.0 View
Hypopituitarism SYSTEMATIC_ASSESSMENT Endocrine disorders 13.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders 13.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders 13.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders 13.0 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders 13.0 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders 13.0 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders 13.0 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders 13.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 13.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Granuloma SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Injection site nodule SYSTEMATIC_ASSESSMENT General disorders 13.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 13.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 13.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 13.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 13.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 13.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations 13.0 View
Blood corticotrophin decreased SYSTEMATIC_ASSESSMENT Investigations 13.0 View
Blood testosterone decreased SYSTEMATIC_ASSESSMENT Investigations 13.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations 13.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations 13.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 13.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 13.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 13.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 13.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 13.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 13.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 13.0 View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 13.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 13.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 13.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 13.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 13.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 13.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 13.0 View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 13.0 View
Haemangioma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 13.0 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders 13.0 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders 13.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders 13.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 13.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders 13.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders 13.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders 13.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders 13.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders 13.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders 13.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders 13.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 13.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 13.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 13.0 View
Paranasal sinus hypersecretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 13.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 13.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 13.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 13.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 13.0 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 13.0 View
Photosensitivity reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 13.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 13.0 View
Pruritus generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 13.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 13.0 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 13.0 View
Rash generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 13.0 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 13.0 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 13.0 View
Rosacea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 13.0 View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 13.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 13.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 13.0 View
Vitiligo SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 13.0 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders 13.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders 13.0 View
Varicose vein SYSTEMATIC_ASSESSMENT Vascular disorders 13.0 View