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| ID | Type | Description | Link |
|---|---|---|---|
| U01AA021891 | U.S. NIH Grant/Contract | View source | |
| IMM-124-E | Other Identifier | VCU |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| Immuron Ltd. | INDUSTRY |
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Hypothesis: Oral administration of hyperimmune bovine colostrum enriched with anti-LPS antibodies will reduce endotoxemia, and improve pathophysiological and clinical parameters related to severe alcoholic hepatitis (SAH).
IMM 124-E is safe in subjects with severe alcoholic hepatitis being treated with steroids.
Aim: To perform a phase 2a "proof of concept" placebo-controlled, dose-ranging study of Imm 124-E (hyperimmune bovine colostrum enriched with IgG anti-LPS) in subjects with severe AH on steroids.
Subjects with severe alcoholic hepatitis (20=> MELD <=28) about to receive prednisolone (40 mg/day x 28 days) will be randomized 1:1:1 to additionally receive either one of two doses of IMM 124-E (2400 mg/day or 4800 mg/day) orally or placebo for the same duration. Standard of care nutrition support and alcohol cessation recommendations will be provided to all subjects. Alcohol withdrawal will be managed per standard of care. Subjects who meet Lille criteria for failure of treatment on day 7 or side effects requiring discontinuation of steroids will be removed from the study. The primary endpoint is a decrease in plasma endotoxin levels.
The secondary endpoints will include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMM 124-E 2400 mg/day | Experimental | Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily. |
|
| IMM 124-E 4800 mg/day | Experimental | Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets. |
|
| Placebo (High protein milk powder) | Placebo Comparator | Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMM 124-E (Hyperimmune Bovine Colostrum) | Drug | Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Safety Endpoints | Number of events and severity of gastrointestinal events, including nausea, vomiting, and diarrhea | 30 Days |
| Combined Kidney, Brain, and Lung Safety Endpoints | Number of incidents of the following: renal failure, encephalopathy or pulmonary compromise. | 30 Days |
| Infection Safety Endpoints | Number of incidents of sepsis. | 30 Days |
| Other Safety Endpoints | Number of incidents of all other serious adverse events and other adverse events not already assessed as a primary outcome. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel Gastrointestinal Safety Endpoints | Number of participants who experience diarrhea | 30 Days |
| Change in Circulating Endotoxin Levels | Changes in endotoxin levels as measured using a standard blood assay |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arun J Sanyal, MBBS MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41691535 | Derived | Blaney H, Asgharpour A. The alcohol-associated hepatitis treatment landscape. Curr Opin Gastroenterol. 2026 May 1;42(3):107-113. doi: 10.1097/MOG.0000000000001158. Epub 2026 Feb 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IMM 124-E 2400 mg/Day | Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily. IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E. Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily |
| FG001 | IMM 124-E 4800 mg/Day | Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets. IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E. |
| FG002 | Placebo (High Protein Milk Powder) | Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily. Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IMM 124-E 2400 mg/Day | Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily. IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E. Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gastrointestinal Safety Endpoints | Number of events and severity of gastrointestinal events, including nausea, vomiting, and diarrhea | Posted | Number | Incidents | 30 Days |
|
Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IMM 124-E 2400 mg/Day | Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily. IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E. Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urinary tract infection | Infections and infestations | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Taylor MSN, RN | Virginia Commonwealth University | 804-828-9311 | stephanie.taylor@vcuhealth.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2016 | Dec 10, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 10, 2017 | Dec 10, 2019 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006519 | Hepatitis, Alcoholic |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
| D020751 | Alcohol-Induced Disorders |
Not provided
Not provided
Not provided
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| Placebo (High protein milk powder) | Drug | Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily |
|
| Baseline, day 28 |
| Lille Model Score | Number of participants who meet Lille criteria indicating failure to respond to treatment | 7 days |
| Mortality | Number of deaths due to any cause | 180 days |
| Change in Liver Function | Model for end-stage liver disease (MELD) score ranges from 6 to 40 with higher number indicating worse liver function. | 90 days |
| SOFA Score | SOFA is a single score based on patient status of six different biological systems: respiratory, cardiovascular, hepatic, coagulation, renal, and neurological. Scores range from 0 to 24 with higher scores indicated worse status. | 30 days |
| Change in Serum Bile Acids | Serum bile acids levels as measured using standard blood serum assay | Baseline to 90 days |
| Time to 50% Drop in Bilirubin | Length of time to a drop in bilirubin of 50% measured in days | 180 days |
| Cytokine Data | Changes in cytokine profile across study arms at day 28 | 28 days |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| BG001 | IMM 124-E 4800 mg/Day | Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets. IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E. |
| BG002 | Placebo (High Protein Milk Powder) | Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily. Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets. IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E. |
| OG002 | Placebo (High Protein Milk Powder) | Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily. Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily |
|
|
| Primary | Combined Kidney, Brain, and Lung Safety Endpoints | Number of incidents of the following: renal failure, encephalopathy or pulmonary compromise. | Posted | Number | incidents | 30 Days |
|
|
|
| Primary | Infection Safety Endpoints | Number of incidents of sepsis. | Posted | Number | Incidents | 30 Days |
|
|
|
| Primary | Other Safety Endpoints | Number of incidents of all other serious adverse events and other adverse events not already assessed as a primary outcome. | Posted | Number | Events | 30 Days |
|
|
|
| Secondary | Bowel Gastrointestinal Safety Endpoints | Number of participants who experience diarrhea | Data were not collected separately for participants who suffered diarrhea. All gastrointestinal events (including diarrhea) were recorded as generic gastrointestinal events and reported in primary outcome #1. | Posted | 30 Days |
|
|
| Secondary | Change in Circulating Endotoxin Levels | Changes in endotoxin levels as measured using a standard blood assay | Posted | Mean | Standard Deviation | ng/mL | Baseline, day 28 |
|
|
|
|
| Secondary | Lille Model Score | Number of participants who meet Lille criteria indicating failure to respond to treatment | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Mortality | Number of deaths due to any cause | Posted | Count of Participants | Participants | 180 days |
|
|
|
| Secondary | Change in Liver Function | Model for end-stage liver disease (MELD) score ranges from 6 to 40 with higher number indicating worse liver function. | Posted | Mean | Standard Deviation | score on a scale | 90 days |
|
|
|
|
| Secondary | SOFA Score | SOFA is a single score based on patient status of six different biological systems: respiratory, cardiovascular, hepatic, coagulation, renal, and neurological. Scores range from 0 to 24 with higher scores indicated worse status. | Data not collected | Posted | 30 days |
|
|
| Secondary | Change in Serum Bile Acids | Serum bile acids levels as measured using standard blood serum assay | Data not collected | Posted | Baseline to 90 days |
|
|
| Secondary | Time to 50% Drop in Bilirubin | Length of time to a drop in bilirubin of 50% measured in days | Data not collected | Posted | 180 days |
|
|
| Secondary | Cytokine Data | Changes in cytokine profile across study arms at day 28 | Data not collected | Posted | 28 days |
|
|
| 5 |
| 18 |
| 11 |
| 18 |
| 18 |
| 18 |
| EG001 | IMM 124-E 4800 mg/Day | Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets. IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E. | 2 | 19 | 9 | 19 | 19 | 19 |
| EG002 | Placebo (High Protein Milk Powder) | Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily. Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily | 2 | 20 | 12 | 20 | 17 | 20 |
| perforated ulcer | General disorders | Non-systematic Assessment |
|
| hepatic encephalopathy | Nervous system disorders | Non-systematic Assessment |
|
| sepsis | Infections and infestations | Non-systematic Assessment |
|
| acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| lactic acidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| alcohol withdrawal syndrome | Psychiatric disorders | Non-systematic Assessment |
|
| metabolic acidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| oedema peripheral | General disorders | Non-systematic Assessment |
|
| hyperglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| blood creatinine abnormal | Investigations | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | Non-systematic Assessment |
|
| alcohol use | Social circumstances | Non-systematic Assessment |
|
| alcoholic liver disease | Hepatobiliary disorders | Non-systematic Assessment |
|
| idiosyncratic alcohol intoxication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| hyponatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| hyperkalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| peritonitis bacterial | Infections and infestations | Non-systematic Assessment |
|
| renal failure acute | Renal and urinary disorders | Non-systematic Assessment |
|
| hypotension | Vascular disorders | Non-systematic Assessment |
|
| gastrointestinal bacterial infection | Infections and infestations | Non-systematic Assessment |
|
| septic shock | Infections and infestations | Non-systematic Assessment |
|
| hepatic cirrhosis | Hepatobiliary disorders | Non-systematic Assessment |
|
| renal injury | Renal and urinary disorders | Non-systematic Assessment |
|
| hyperbilirubinaemia | Hepatobiliary disorders | Non-systematic Assessment |
|
| leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| fluid imbalance | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| endotracheal intubation | Surgical and medical procedures | Non-systematic Assessment |
|
| hepatorenal syndrome | Hepatobiliary disorders | Non-systematic Assessment |
|
| multi-organ failure | General disorders | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| blood glucose increased | Investigations | Non-systematic Assessment |
|
| dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| cirrhosis alcoholic | Hepatobiliary disorders | Non-systematic Assessment |
|
| upper gastrointestinal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| ascites | Gastrointestinal disorders | Non-systematic Assessment |
|
| dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| pneumoperitoneum | Gastrointestinal disorders | Non-systematic Assessment |
|
| explorative laparotomy | Surgical and medical procedures | Non-systematic Assessment |
|
| large intestine perforation | Gastrointestinal disorders | Non-systematic Assessment |
|
| hypercalcaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| hepatic function abnormal | Hepatobiliary disorders | Non-systematic Assessment |
|
| pneumonia fungal | Infections and infestations | Non-systematic Assessment |
|
| liver transplant | Surgical and medical procedures | Non-systematic Assessment |
|
| hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| lobar pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| hepatic hydrothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| systemic inflammatory response syndrome | General disorders | Non-systematic Assessment |
|
| mental status changes | Psychiatric disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| chronic gastrointestinal bleeding | Gastrointestinal disorders | Non-systematic Assessment |
|
| generalised oedema | General disorders | Non-systematic Assessment |
|
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| alcohol detoxification | Surgical and medical procedures | Non-systematic Assessment |
|
| pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| skin infection | Infections and infestations | Non-systematic Assessment |
|
| abdominal infection | Infections and infestations | Non-systematic Assessment |
|
| Oedema | General disorders | Non-systematic Assessment |
|
| renal injury | Renal and urinary disorders | Non-systematic Assessment |
|
| phlebitis | Vascular disorders | Non-systematic Assessment |
|
| diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| hypoglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | Non-systematic Assessment |
|
| dysgeusia | Nervous system disorders | Non-systematic Assessment |
|
| hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| cellulitis | Infections and infestations | Non-systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| diabetes mellitus | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| psychogenic seizure | Psychiatric disorders | Non-systematic Assessment |
|
| abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
|
| compression fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| osteopenia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| transaminases increased | Investigations | Non-systematic Assessment |
|
| portal hypertensive gastropathy | Gastrointestinal disorders | Non-systematic Assessment |
|
| infective exacerbation of bronchiectasis | Infections and infestations | Non-systematic Assessment |
|
| varices oesophageal | Gastrointestinal disorders | Non-systematic Assessment |
|
| oral fungal infection | Infections and infestations | Non-systematic Assessment |
|
| muscle strain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| protein c deficiency | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| hypotension | Vascular disorders | Non-systematic Assessment |
|
| metabolic acidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| fungal skin infection | Infections and infestations | Non-systematic Assessment |
|
| excoriation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| atelectasis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| calciphylaxis | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| skin necrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| body temperature increased | Investigations | Non-systematic Assessment |
|
| oedema peripheral | General disorders | Non-systematic Assessment |
|
| central venous catheterisation | Surgical and medical procedures | Non-systematic Assessment |
|
| bladder catheterisation | Surgical and medical procedures | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| oral candidiasis | Infections and infestations | Non-systematic Assessment |
|
| debridement | Surgical and medical procedures | Non-systematic Assessment |
|
| antiphospholipid antibodies positive | Investigations | Non-systematic Assessment |
|
| portal hypertension | Hepatobiliary disorders | Non-systematic Assessment |
|
| cholecystitis acute | Hepatobiliary disorders | Non-systematic Assessment |
|
| lesion excision | Surgical and medical procedures | Non-systematic Assessment |
|
| acidosis | Metabolism and nutrition disorders | Non-systematic Assessment | mixed respiratory and metabolic |
|
| mental status changes | Psychiatric disorders | Non-systematic Assessment |
|
| culture wound positive | Investigations | Non-systematic Assessment |
|
| malnutrition | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| skin wound | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| bowel movement irregularity | Gastrointestinal disorders | Non-systematic Assessment |
|
| urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
|
| hypovitaminosis | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| nipple pain | Reproductive system and breast disorders | Non-systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| chills | General disorders | Non-systematic Assessment |
|
| tremor | Nervous system disorders | Non-systematic Assessment |
|
| dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| respiratory disorder | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| muscular weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| joint stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| tongue abscess | Infections and infestations | Non-systematic Assessment |
|
| flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| hyperammonaemia | Investigations | Non-systematic Assessment |
|
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| hyperthermia | General disorders | Non-systematic Assessment |
|
| ascites | Gastrointestinal disorders | Non-systematic Assessment |
|
| asterixis | Nervous system disorders | Non-systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| jaundice | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| haematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| blister | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| oral pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| gingivitis | Infections and infestations | Non-systematic Assessment |
|
| parotid gland enlargement | Gastrointestinal disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| alcohol withdrawal syndrome | Psychiatric disorders | Non-systematic Assessment |
|
| dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| ecchymosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| blood creatinine increased | Investigations | Non-systematic Assessment |
|
| glomerular filtration rate abnormal | Investigations | Non-systematic Assessment |
|
| cachexia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| skin lesion | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| hepatic encephalopathy | Nervous system disorders | Non-systematic Assessment |
|
| hyperkalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| lipase abnormal | Investigations | Non-systematic Assessment |
|
| blood alkaline phosphatase increased | Investigations | Non-systematic Assessment |
|
| drug reaction with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| malaise | General disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| renal failure acute | Renal and urinary disorders | Non-systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| hyponatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| hypoalbuminaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| coagulopathy | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| peripheral neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| blood bilirubin increased | Investigations | Non-systematic Assessment |
|
| presyncope | Nervous system disorders | Non-systematic Assessment |
|
| hallucination, visual | Psychiatric disorders | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| abnormal weight gain | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| sinus tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| vision blurred | Eye disorders | Non-systematic Assessment |
|
| skin striae | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| lethargy | Nervous system disorders | Non-systematic Assessment |
|
| agitation | Psychiatric disorders | Non-systematic Assessment |
|
| polyuria | Renal and urinary disorders | Non-systematic Assessment |
|
| polydipsia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| epigastric discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| urine bilirubin increased | Investigations | Non-systematic Assessment |
|
| weight decreased | Investigations | Non-systematic Assessment |
|
| depression | Psychiatric disorders | Non-systematic Assessment |
|
| oliguria | Renal and urinary disorders | Non-systematic Assessment |
|
| hallucination, auditory | Psychiatric disorders | Non-systematic Assessment |
|
| hypercalcaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| hypomagnesaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| hypophosphataemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| hypothyroidism | Endocrine disorders | Non-systematic Assessment |
|
| anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| herpes dermatitis | Infections and infestations | Non-systematic Assessment |
|
| bronchitis | Infections and infestations | Non-systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| hyperglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| blood lactate dehydrogenase increased | Investigations | Non-systematic Assessment |
|
| suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
|
| pancytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| brain abscess | Infections and infestations | Non-systematic Assessment |
|
| seizure like phenomena | Nervous system disorders | Non-systematic Assessment |
|
| lactic acidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| pyrexia | General disorders | Non-systematic Assessment |
|
| hyperphosphataemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| memory impairment | Nervous system disorders | Non-systematic Assessment |
|
| thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| haematochezia | Gastrointestinal disorders | Non-systematic Assessment |
|
| anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| nasal inflammation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| bladder pain | Renal and urinary disorders | Non-systematic Assessment |
|
| amenorrhoea | Reproductive system and breast disorders | Non-systematic Assessment |
|
| spider naevus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| adrenal insufficiency | Endocrine disorders | Non-systematic Assessment |
|
| Coxsackie viral infection | Infections and infestations | Non-systematic Assessment |
|
| haemorrhoids | Gastrointestinal disorders | Non-systematic Assessment |
|
| hyper IgE syndrome | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| intrahepatic portal hepatic venous fistula | Hepatobiliary disorders | Non-systematic Assessment |
|
| musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| Title | Measurements |
|---|---|
|
| Pulmonary compromise |
|