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 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
NCT ID:
NCT02178358
Description:
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Frequency Threshold:
5
Time Frame:
Up To 63 Months
Study:
NCT02178358
Study Brief:
A Study of LY2157299 in Participants With Advanced Hepatocellular Carcinoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 150 mg Galunisertib Monotherapy | 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle). | 15 | None | 6 | 20 | 17 | 20 | View |
| 150 mg Galunisertib + 400 mg Sorafenib Therapy | 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days. | 58 | None | 31 | 74 | 73 | 74 | View |
| 400 mg Sorafenib + Placebo Therapy | Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days. | 31 | None | 11 | 38 | 38 | 38 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Oesophageal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Streptococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Hepatic rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Troponin i increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Haemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Hepatic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Azotaemia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.0 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Duodenal ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Food poisoning | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Gastritis haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Haemorrhoidal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Oesophageal varices haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Varices oesophageal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 20.0 | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 20.0 | View |
| Hepatic haemorrhage | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 20.0 | View |
| Jaundice | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 20.0 | View |
| Anal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Biliary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Endocarditis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.0 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.0 | View |
| Hearing impaired | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.0 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 20.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Rash pustular | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Thyroxine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.0 | View |
| Genital disorder female | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.0 | View |
| Genital rash | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Dermatitis acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Erythema multiforme | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |