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The study is terminated due to major protocol revisions. A new study in CLL patients is planned.
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A Phase I/II Dose-Escalation and Expansion Study Of The Selective PKC-Î’ Inhibitor MS-553 In Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I Dose Escalation Cohort A1 (MS-553 Monotherapy) | Experimental | R/R CLL/SLL patients |
|
| Phase II Expansion Cohort A2 (MS-553 Monotherapy) | Experimental | R/R CLL/SLL patients |
|
| Phase II Expansion Cohort A3 (MS-553 Monotherapy) | Experimental | patients with aggressive lymphoma |
|
| Phase I Combination Dose Escalation Cohort B1 | Experimental | BTK inhibitor naïve CLL/SLL patients |
|
| Phase II Expansion Cohort B2 | Experimental | BTK inhibitor naïve CLL/SLL patients |
|
| Phase II Expansion Cohort B3 | Experimental | BTK inhibitor naïve CLL/SLL patients with certain gene mutations |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MS-553 | Drug | Oral, multiple dose levels |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence Rate of DLT and TEAE Requiring Study Drug Discontinuation | DLT are defined as any of the following treatment-emergent events occurring during the DLT evaluation period. 1. Death 2. Hematologic toxicities: • Grade 4 neutropenia for ≥ 7 days • Grade 3 febrile neutropenia: absolute neutrophil count (ANC) 38.3°C (101°F) or a sustained temperature ≥38°C (100.4°F) for > 1 hour • Grade 4 thrombocytopenia ≥ 14 days (patients with baseline platelet count of ≥ 50 x 109 /L) • Grade 4 thrombocytopenia ≥ 28 days (patients with baseline platelet count < 50 x 10 9 /L) • ≥ Grade 3 thrombocytopenia associated with ≥ Grade 2 hemorrhage • New ≥ Grade 3 anemia requiring transfusion in a patient previously transfusion independent. 3. Nonhematologic toxicities: • Any other ≥ Grade 3 toxicity not reversed to any one of the following three conditions in 7 days with appropriate intervention: a) baseline; b) < Grade 1; or c) a status considered to be controlled by the SRC. • Any TEAE requiring >25% of doses of scheduled study drug to be withheld during the DLT period | Assessments for DLT and TEAE will occur during Cycle 1 (28 days) for A1 Cohort and B1 Cohort and Cycles 1-4 (up to 112 days) for C1 Cohort. |
| Measure | Description | Time Frame |
|---|---|---|
| The ORR of MS-553 in Patients With CLL/SLL Whose Disease Relapsed After or Was Refractory to at Least One Prior Therapy | This will be assessed according to the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Response Criteria with modifications for treatment-related lymphocytosis. Any patient who receives at least one cycle of study therapy is evaluable for response. | Evaluation of the efficacy endpoints related to response will incorporate the data from the first 9 cycles (up to 252 days) of treatment. |
Not provided
Inclusion Criteria:
To be eligible for inclusion in the primary escalation and expansion cohort 1 in this study, patients must meet all of the following criteria:
Age 18 years or older
Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL):
Exclusion Criteria:
Patients who meet any of the following criteria are not eligible for the primary escalation and expansion cohorts of this study:
Current or past transformation of CLL/SLL to prolymphocytic leukemia (PLL), non-Hodgkin lymphoma, or Hodgkin lymphoma aggressive lymphoma outlined in the inclusion criteria for the optional cohort.
Active and uncontrolled autoimmune cytopenia(s)
Any of the following prior therapies within 14 days prior to cycle 1, day 1:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States | ||
| Columbia University, Herbert Irving Comprehensive Cancer Center |
No participants were enrolled in Cohort B2, B3 or C2
Participants enrolled between May 2018 and Oct. 2023
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I Dose Escalation Cohort A1 (MS-553:100 mg BID) | R/R CLL/SLL patients MS-553 Monotherapy: Oral |
| FG001 | Phase I Dose Escalation Cohort A1 (MS-553: 200 mg BID) | Refractory/Relapsed CLL/SLL patients MS-553 Monotherapy: Oral |
| FG002 | Phase I Dose Escalation Cohort A1 (MS-553: 250 mg BID) | Refractory/Relapsed CLL/SLL patients MS-553 Monotherapy: Oral |
| FG003 | Phase I Dose Escalation Cohort A1 (MS-553: 300 mg BID) | Refractory/Relapsed CLL/SLL patients MS-553 Monotherapy: Oral |
| FG004 | Phase I Dose Escalation Cohort A1 (MS-553: 350 mg BID) | Refractory/Relapsed CLL/SLL patients MS-553 Monotherapy: Oral |
| FG005 | Phase II Expansion Cohort A2 (MS-553 Monotherapy) | R/R CLL/SLL patients MS-553: Oral recommended phase 2 dose of MS-553 |
| FG006 | Phase II Expansion Cohort A3 (MS-553 Monotherapy) | patients with Richter's transformation or aggressive lymphoma MS-553: Oral recommended phase 2 dose of MS-553 |
| FG007 | Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID) | BTK inhibitor naïve CLL/SLL patients MS-553: Oral acalabrutinib: Oral |
| FG008 | Phase I Combination Dose Escalation Cohort B1 (MS: 553: 200 mg BID) | BTK inhibitor naïve CLL/SLL patients MS-553: Oral acalabrutinib: Oral |
| FG009 | Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID) | Bcl-2 inhibitor naïve CLL/SLL patients MS-553: Oral venetoclax: Oral Rituximab: IV obinutuzumab: IV |
| FG010 | Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID) | Bcl-2 inhibitor naïve CLL/SLL patients MS-553: Oral venetoclax: Oral Rituximab: IV obinutuzumab: IV |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DLT Evaluation Period |
| |||||||||||||
| Dose Expansion Period |
|
Treated population included all participants who had received at least one dose of the study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I Dose Escalation Cohort A1 (MS-553: 100 mg BID) | R/R CLL/SLL patients MS-553 Monotherapy: Oral |
| BG001 | Phase I Dose Escalation Cohort A1 (MS-553: 200 mg BID) | R/R CLL/SLL patients MS-553 Monotherapy: Oral |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Incidence Rate of DLT and TEAE Requiring Study Drug Discontinuation | DLT are defined as any of the following treatment-emergent events occurring during the DLT evaluation period. 1. Death 2. Hematologic toxicities: • Grade 4 neutropenia for ≥ 7 days • Grade 3 febrile neutropenia: absolute neutrophil count (ANC) 38.3°C (101°F) or a sustained temperature ≥38°C (100.4°F) for > 1 hour • Grade 4 thrombocytopenia ≥ 14 days (patients with baseline platelet count of ≥ 50 x 109 /L) • Grade 4 thrombocytopenia ≥ 28 days (patients with baseline platelet count < 50 x 10 9 /L) • ≥ Grade 3 thrombocytopenia associated with ≥ Grade 2 hemorrhage • New ≥ Grade 3 anemia requiring transfusion in a patient previously transfusion independent. 3. Nonhematologic toxicities: • Any other ≥ Grade 3 toxicity not reversed to any one of the following three conditions in 7 days with appropriate intervention: a) baseline; b) < Grade 1; or c) a status considered to be controlled by the SRC. • Any TEAE requiring >25% of doses of scheduled study drug to be withheld during the DLT period | DLT evaluable population (Phase 1 only) included all participants who had completed at least 75% of their planned doses during Cycle 1 or the DLT period, unless missed doses were due to adverse events. | Posted | Count of Participants | Participants | Assessments for DLT and TEAE will occur during Cycle 1 (28 days) for A1 Cohort and B1 Cohort and Cycles 1-4 (up to 112 days) for C1 Cohort. |
For the duration of the study drug treatment (up to 3 years)
The Safety Population included all participants who were enrolled and received at least one dose of study drug
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I Dose Escalation Cohort A1 (MS-553: 100 mg BID) | R/R CLL/SLL patients MS-553 Monotherapy: Oral |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemias NEC | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kai Zhang | MingSight Pharmaceuticals | 8582055958 | kzhang@mingsight.com |
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| 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 | Jun 16, 2023 | Apr 7, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000604908 | acalabrutinib |
| C579720 | venetoclax |
| D000069283 | Rituximab |
| C543332 | obinutuzumab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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a limited 3+3 phase 1 dose escalation study with expansion cohorts
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|
| Phase I Combination Dose Escalation Cohort C1 | Experimental | Bcl-2 inhibitor naïve CLL/SLL patients |
|
| Experimental: Phase II Expansion Cohort C2 | Experimental | Bcl-2 inhibitor naïve CLL/SLL patients |
|
| MS-553 | Drug | Oral recommended phase 2 dose of MS-553 |
|
| acalabrutinib | Drug | Oral |
|
| venetoclax | Drug | Oral |
|
|
| Rituximab | Drug | IV |
|
|
| obinutuzumab | Drug | IV |
|
|
| New York |
| New York |
| 10032 |
| United States |
| The Ohio State University, James Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| MD Anderson Cancer Center, Department of Leukemia | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Phase I Dose Escalation Cohort A1 (MS-553: 250 mg BID) | R/R CLL/SLL patients MS-553 Monotherapy: Oral |
| BG003 | Phase I Dose Escalation Cohort A1 (MS-553: 300 mg BID) | R/R CLL/SLL patients MS-553 Monotherapy: Oral |
| BG004 | Phase I Dose Escalation Cohort A1 (MS-553: 350 mg BID) | R/R CLL/SLL patients MS-553 Monotherapy: Oral |
| BG005 | Phase II Expansion Cohort A2 (MS-553 Monotherapy) | R/R CLL/SLL patients MS-553: Oral recommended phase 2 dose of MS-553 |
| BG006 | Phase II Expansion Cohort A3 (MS-553 Monotherapy) | patients with Richter's transformation or aggressive lymphoma MS-553: Oral recommended phase 2 dose of MS-553 |
| BG007 | Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID) | BTK inhibitor naïve CLL/SLL patients MS-553: Oral acalabrutinib: Oral |
| BG008 | Phase I Combination Dose Escalation Cohort B1 (MS-553:200 mg BID) | BTK inhibitor naïve CLL/SLL patients MS-553: Oral acalabrutinib: Oral |
| BG009 | Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID) | Bcl-2 inhibitor naïve CLL/SLL patients MS-553: Oral venetoclax: Oral Rituximab: IV obinutuzumab: IV |
| BG010 | Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID) | Bcl-2 inhibitor naïve CLL/SLL patients MS-553: Oral venetoclax: Oral Rituximab: IV obinutuzumab: IV |
| BG011 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | The ORR of MS-553 in Patients With CLL/SLL Whose Disease Relapsed After or Was Refractory to at Least One Prior Therapy | This will be assessed according to the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Response Criteria with modifications for treatment-related lymphocytosis. Any patient who receives at least one cycle of study therapy is evaluable for response. | Consisting of all patients who received at least one dose of study therapy of MS-553 and had at least one post-baseline efficacy evaluation. | Posted | Number | percentage of participants | Evaluation of the efficacy endpoints related to response will incorporate the data from the first 9 cycles (up to 252 days) of treatment. |
|
|
|
| 1 |
| 4 |
| 2 |
| 4 |
| 4 |
| 4 |
| EG001 | Phase I Dose Escalation Cohort A1 (MS-553: 200 mg BID) | R/R CLL/SLL patients MS-553 Monotherapy: Oral | 2 | 3 | 3 | 3 | 3 | 3 |
| EG002 | Phase I Dose Escalation Cohort A1 (MS-553: 250 mg BID) | R/R CLL/SLL patients MS-553 Monotherapy: Oral | 1 | 3 | 1 | 3 | 3 | 3 |
| EG003 | Phase I Dose Escalation Cohort A1 (MS-553: 300 mg BID) | R/R CLL/SLL patients MS-553 Monotherapy: Oral | 2 | 4 | 3 | 4 | 4 | 4 |
| EG004 | Phase I Dose Escalation Cohort A1 (MS-553: 350 mg BID) | R/R CLL/SLL patients MS-553 Monotherapy: Oral | 2 | 4 | 3 | 4 | 4 | 4 |
| EG005 | Phase II Expansion Cohort A2 (MS-553 Monotherapy) | R/R CLL/SLL patients MS-553: Oral recommended phase 2 dose of MS-553 | 6 | 23 | 15 | 23 | 23 | 23 |
| EG006 | Phase II Expansion Cohort A3 (MS-553 Monotherapy) | patients with Richter's transformation or aggressive lymphoma MS-553: Oral recommended phase 2 dose of MS-553 | 3 | 6 | 3 | 6 | 6 | 6 |
| EG007 | Phase I Combination Dose Escalation Cohort B1 (MS-553: 150 mg BID) | BTK inhibitor naïve CLL/SLL patients MS-553: Oral acalabrutinib: Oral | 0 | 3 | 1 | 3 | 3 | 3 |
| EG008 | Phase I Combination Dose Escalation Cohort B1 (MS-553: 200 mg BID) | BTK inhibitor naïve CLL/SLL patients MS-553: Oral acalabrutinib: Oral | 0 | 3 | 2 | 3 | 3 | 3 |
| EG009 | Phase I Combination Dose Escalation Cohort C1 (MS-553: 150 mg BID) | Bcl-2 inhibitor naïve CLL/SLL patients MS-553: Oral venetoclax: Oral Rituximab: IV obinutuzumab: IV | 0 | 3 | 2 | 3 | 3 | 3 |
| EG010 | Phase I Combination Dose Escalation Cohort C1 (MS-553: 200 mg BID) | Bcl-2 inhibitor naïve CLL/SLL patients MS-553: Oral venetoclax: Oral Rituximab: IV obinutuzumab: IV | 0 | 4 | 2 | 4 | 4 | 4 |
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Mesenteric artery thrombosis | Gastrointestinal disorders | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Sudden death | General disorders | Systematic Assessment |
|
| Disease progression | General disorders | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Lung infection | Infections and infestations | Systematic Assessment |
|
| Pneumonia parainfluenzae viral | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | Systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | Systematic Assessment |
|
| Skin infection | Infections and infestations | Systematic Assessment |
|
| Abscess limb | Infections and infestations | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
|
| White blood cell count decreased | Investigations | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | Systematic Assessment |
|
| Tumor lysis syndrome | Metabolism and nutrition disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Aortic thrombosis | Vascular disorders | Systematic Assessment |
|
| Arterial thrombosis | Vascular disorders | Systematic Assessment |
|
| Embolism arterial | Vascular disorders | Systematic Assessment |
|
| Bleeding tendencies | Blood and lymphatic system disorders | Systematic Assessment |
|
| Eosinophilic disorders | Blood and lymphatic system disorders | Systematic Assessment |
|
| Leukocytoses NEC | Blood and lymphatic system disorders | Systematic Assessment |
|
| Lymphatic system disorders NEC | Blood and lymphatic system disorders | Systematic Assessment |
|
| Neutropenias | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenias | Blood and lymphatic system disorders | Systematic Assessment |
|
| Aortic valvular disorders | Cardiac disorders | Systematic Assessment |
|
| Cardiac conduction disorders | Cardiac disorders | Systematic Assessment |
|
| Cardiac signs and symptoms NEC | Cardiac disorders | Systematic Assessment |
|
| Pericardial disorders NEC | Cardiac disorders | Systematic Assessment |
|
| Supraventricular arrhythmias | Cardiac disorders | Systematic Assessment |
|
| Ear disorders NEC | Ear and labyrinth disorders | Systematic Assessment |
|
| External ear disorders NEC | Ear and labyrinth disorders | Systematic Assessment |
|
| Choroid and vitreous structural change, deposit and degeneration | Eye disorders | Systematic Assessment |
|
| Lacrimation disorders | Eye disorders | Systematic Assessment |
|
| Ocular bleeding and vascular disorders NEC | Eye disorders | Systematic Assessment |
|
| Ocular disorders NEC | Eye disorders | Systematic Assessment |
|
| Ocular sensation disorders | Eye disorders | Systematic Assessment |
|
| Pupil disorders | Eye disorders | Systematic Assessment |
|
| Visual disorders NEC | Eye disorders | Systematic Assessment |
|
| Colitis (excl infective) | Gastrointestinal disorders | Systematic Assessment |
|
| Dental and periodontal infections and inflammations | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea (excl infective) | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspeptic signs and symptoms | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence, bloating and distension | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal and abdominal pains (excl oral and throat) | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal atonic and hypomotility disorders NEC | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal inflammatory disorders NEC | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal signs and symptoms NEC | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal spastic and hypermotility disorders | Gastrointestinal disorders | Systematic Assessment |
|
| Haemorrhoids and gastrointestinal varices (excl oesophageal) | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea and vomiting symptoms | Gastrointestinal disorders | Systematic Assessment |
|
| Oral dryness and saliva altered | Gastrointestinal disorders | Systematic Assessment |
|
| Oral soft tissue pain and paraesthesia | Gastrointestinal disorders | Systematic Assessment |
|
| Peritoneal and retroperitoneal disorders | Gastrointestinal disorders | Systematic Assessment |
|
| Stomatitis and ulceration | Gastrointestinal disorders | Systematic Assessment |
|
| Tongue signs and symptoms | Gastrointestinal disorders | Systematic Assessment |
|
| Asthenic conditions | General disorders | Systematic Assessment |
|
| Febrile disorders | General disorders | Systematic Assessment |
|
| Feelings and sensations NEC | General disorders | Systematic Assessment |
|
| Gait disturbances | General disorders | Systematic Assessment |
|
| General signs and symptoms NEC | General disorders | Systematic Assessment |
|
| Healing abnormal NEC | General disorders | Systematic Assessment |
|
| Implant and catheter site reactions | General disorders | Systematic Assessment |
|
| Infusion site reactions | General disorders | Systematic Assessment |
|
| Mucosal findings abnormal | General disorders | Systematic Assessment |
|
| Oedema NEC | General disorders | Systematic Assessment |
|
| Pain and discomfort NEC | General disorders | Systematic Assessment |
|
| Cholecystitis and cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
|
| Allergic conditions NEC | Immune system disorders | Systematic Assessment |
|
| Immunodeficiency disorders NEC | Immune system disorders | Systematic Assessment |
|
| Abdominal and gastrointestinal infections | Infections and infestations | Systematic Assessment |
|
| Bacterial infections NEC | Infections and infestations | Systematic Assessment |
|
| Candida infections | Infections and infestations | Systematic Assessment |
|
| Clostridia infections | Infections and infestations | Systematic Assessment |
|
| Dental and oral soft tissue infections | Infections and infestations | Systematic Assessment |
|
| Ear infections | Infections and infestations | Systematic Assessment |
|
| Eye and eyelid infections | Infections and infestations | Systematic Assessment |
|
| Female reproductive tract infections | Infections and infestations | Systematic Assessment |
|
| Herpes viral infections | Infections and infestations | Systematic Assessment |
|
| Infections NEC | Infections and infestations | Systematic Assessment |
|
| Lower respiratory tract and lung infections | Infections and infestations | Systematic Assessment |
|
| Skin structures and soft tissue infections | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infections | Infections and infestations | Systematic Assessment |
|
| Urinary tract infections | Infections and infestations | Systematic Assessment |
|
| Viral infections NEC | Infections and infestations | Systematic Assessment |
|
| Non-site specific injuries NEC | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Non-site specific procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Overdoses NEC | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Radiation injuries | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Site specific injuries NEC | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Skin injuries NEC | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Spinal fractures and dislocations | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Thermal burns | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Vaccination related complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Carbohydrate tolerance analyses (incl diabetes) | Investigations | Systematic Assessment |
|
| Coagulation and bleeding analyses | Investigations | Systematic Assessment |
|
| ECG investigations | Investigations | Systematic Assessment |
|
| Liver function analyses | Investigations | Systematic Assessment |
|
| Mineral and electrolyte analyses | Investigations | Systematic Assessment |
|
| Physical examination procedures and organ system status | Investigations | Systematic Assessment |
|
| Platelet analyses | Investigations | Systematic Assessment |
|
| Renal function analyses | Investigations | Systematic Assessment |
|
| Skeletal and cardiac muscle analyses | Investigations | Systematic Assessment |
|
| Tissue enzyme analyses NEC | Investigations | Systematic Assessment |
|
| White blood cell analyses | Investigations | Systematic Assessment |
|
| Appetite disorders | Metabolism and nutrition disorders | Systematic Assessment |
|
| Calcium metabolism disorders | Metabolism and nutrition disorders | Systematic Assessment |
|
| Disorders of purine metabolism | Metabolism and nutrition disorders | Systematic Assessment |
|
| Electrolyte imbalance NEC | Metabolism and nutrition disorders | Systematic Assessment |
|
| General nutritional disorders NEC | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglycaemic conditions NEC | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoglycaemic conditions NEC | Metabolism and nutrition disorders | Systematic Assessment |
|
| Magnesium metabolism disorders | Metabolism and nutrition disorders | Systematic Assessment |
|
| Metabolic alkaloses | Metabolism and nutrition disorders | Systematic Assessment |
|
| Phosphorus metabolism disorders | Metabolism and nutrition disorders | Systematic Assessment |
|
| Potassium imbalance | Metabolism and nutrition disorders | Systematic Assessment |
|
| Protein metabolism disorders NEC | Metabolism and nutrition disorders | Systematic Assessment |
|
| Sodium imbalance | Metabolism and nutrition disorders | Systematic Assessment |
|
| Total fluid volume decreased | Metabolism and nutrition disorders | Systematic Assessment |
|
| Total fluid volume increased | Metabolism and nutrition disorders | Systematic Assessment |
|
| Water soluble vitamin deficiencies | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthropathies NEC | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bone disorders NEC | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bone related signs and symptoms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bursal disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint related signs and symptoms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle pains | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle related signs and symptoms NEC | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle weakness conditions | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal and connective tissue conditions NEC | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal and connective tissue pain and discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Soft tissue disorders NEC | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Spine and neck deformities | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Diffuse large B-cell lymphomas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Endocrine neoplasms malignant and unspecified NEC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Skin neoplasms benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Skin neoplasms malignant and unspecified (excl melanoma) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Auditory nerve disorders | Nervous system disorders | Systematic Assessment |
|
| Central nervous system haemorrhages and cerebrovascular accidents | Nervous system disorders | Systematic Assessment |
|
| Coordination and balance disturbances | Nervous system disorders | Systematic Assessment |
|
| Cortical dysfunction NEC | Nervous system disorders | Systematic Assessment |
|
| Disturbances in consciousness NEC | Nervous system disorders | Systematic Assessment |
|
| Dyskinesias and movement disorders NEC | Nervous system disorders | Systematic Assessment |
|
| Encephalopathies NEC | Nervous system disorders | Systematic Assessment |
|
| Headaches NEC | Nervous system disorders | Systematic Assessment |
|
| Lumbar spinal cord and nerve root disorders | Nervous system disorders | Systematic Assessment |
|
| Memory loss (excl dementia) | Nervous system disorders | Systematic Assessment |
|
| Mental impairment (excl dementia and memory loss) | Nervous system disorders | Systematic Assessment |
|
| Mononeuropathies | Nervous system disorders | Systematic Assessment |
|
| Neurological signs and symptoms NEC | Nervous system disorders | Systematic Assessment |
|
| Olfactory nerve disorders | Nervous system disorders | Systematic Assessment |
|
| Paraesthesias and dysaesthesias | Nervous system disorders | Systematic Assessment |
|
| Peripheral neuropathies NEC | Nervous system disorders | Systematic Assessment |
|
| Sensory abnormalities NEC | Nervous system disorders | Systematic Assessment |
|
| Anxiety symptoms | Psychiatric disorders | Systematic Assessment |
|
| Confusion and disorientation | Psychiatric disorders | Systematic Assessment |
|
| Deliria | Psychiatric disorders | Systematic Assessment |
|
| Depressive disorders | Psychiatric disorders | Systematic Assessment |
|
| Disturbances in initiating and maintaining sleep | Psychiatric disorders | Systematic Assessment |
|
| Increased physical activity levels | Psychiatric disorders | Systematic Assessment |
|
| Sleep disorders NEC | Psychiatric disorders | Systematic Assessment |
|
| Bladder and urethral symptoms | Renal and urinary disorders | Systematic Assessment |
|
| Renal failure and impairment | Renal and urinary disorders | Systematic Assessment |
|
| Urinary abnormalities | Renal and urinary disorders | Systematic Assessment |
|
| Prostatic neoplasms and hypertrophy | Reproductive system and breast disorders | Systematic Assessment |
|
| Breathing abnormalities | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bronchial conditions NEC | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bronchospasm and obstruction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Conditions associated with abnormal gas exchange | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Coughing and associated symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Laryngeal and adjacent sites disorders NEC (excl infections and neoplasms) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal congestion and inflammations | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal disorders NEC | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Parenchymal lung disorders NEC | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pharyngeal disorders (excl infections and neoplasms) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax and pleural effusions NEC | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary oedemas | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory tract disorders NEC | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Upper respiratory tract signs and symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acnes | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Alopecias | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Apocrine and eccrine gland disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dermal and epidermal conditions NEC | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dermatitis and eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Erythemas | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Exfoliative conditions | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nail and nail bed conditions (excl infections and infestations) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pilar disorders NEC | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus NEC | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Purpura and related conditions | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rashes, eruptions and exanthems NEC | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin and subcutaneous tissue ulcerations | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin injuries and mechanical dermatoses | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin preneoplastic conditions NEC | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Lens therapeutic procedures | Surgical and medical procedures | Systematic Assessment |
|
| Haemorrhages NEC | Vascular disorders | Systematic Assessment |
|
| Lymphoedemas | Vascular disorders | Systematic Assessment |
|
| Peripheral embolism and thrombosis | Vascular disorders | Systematic Assessment |
|
| Peripheral vascular disorders NEC | Vascular disorders | Systematic Assessment |
|
| Phlebitis NEC | Vascular disorders | Systematic Assessment |
|
| Vascular hypertensive disorders NEC | Vascular disorders | Systematic Assessment |
|
| Vascular hypotensive disorders | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |