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:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
NCT ID:
NCT04340193
Description:
All treated participants included all enrolled participants who received at least one dose of any study treatment.
Frequency Threshold:
5
Time Frame:
All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
Study:
NCT04340193
Study Brief:
A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| NIVO+TACE | Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding. | 2 | None | 6 | 9 | 9 | 9 | View |
| NIVO+IPI+TACE | Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. | 2 | None | 7 | 9 | 9 | 9 | View |
| TACE | Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding. | 0 | None | 2 | 8 | 8 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 26.1 | View |
| Hepatic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Klebsiella bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| International normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Cell death | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Malignant neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.1 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Hepatic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Tubulointerstitial nephritis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 26.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 26.1 | View |
| Cardiovascular disorder | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 26.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 26.1 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 26.1 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 26.1 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 26.1 | View |
| Thyroiditis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 26.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Anal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Chronic gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Vulvovaginal mycotic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Bone contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Craniofacial fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Hepatobiliary procedural complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Incision site pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Post embolisation syndrome | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Skin injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Tooth fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Traumatic haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 26.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Blood thyroid stimulating hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Gastric pH decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Inflammatory marker increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Oxygen saturation decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | 26.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Fluid retention | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Hyperammonaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 26.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Psoriatic arthropathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 26.1 | View |
| Malignant neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Hepatic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 26.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 26.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 26.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 26.1 | View |
| Hypertonic bladder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 26.1 | View |
| Tubulointerstitial nephritis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 26.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 26.1 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Onychoclasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Photosensitivity reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Skin hypopigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 26.1 | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | 26.1 | View |
| Raynaud's phenomenon | SYSTEMATIC_ASSESSMENT | Vascular disorders | 26.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Faeces discoloured | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Gastrointestinal angiodysplasia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Portal hypertensive gastropathy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Varices oesophageal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 26.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Device related thrombosis | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Feeling hot | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Inflammation | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 26.1 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 26.1 | View |
| Hypertransaminasaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 26.1 | View |
| Contrast media allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | 26.1 | View |
| Abdominal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Anal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Bacteriuria | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Dermo-hypodermitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Enteritis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Genital herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Helicobacter infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | 26.1 | View |