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| ID | Type | Description | Link |
|---|---|---|---|
| H8K-MC-JZAJ | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine a safe dose of LY573636-sodium to be given to patients with acute myeloid leukemia and to determine any side effects that may be associated with LY573636-sodium in this patient population. Efficacy measures will also be used to assess the activity of LY573636-sodium in acute myeloid leukemia and essential thrombocythemia patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY573636 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY573636-sodium | Drug | Individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Dosing will be done on Day 1 of a 35-day cycle for acute myeloid leukemia (AML) and Day 1 of a 28-day cycle for essential thrombocythemia (ET) for at least one cycle. A participant may have additional cycles of LY573636 if he or she is receiving benefit from the study drug and does not fulfill any of the criteria for study discontinuation. |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase 2 Dose of LY573636-Sodium in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) and Essential Thrombocythemia (ET) | Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD is the highest dose at which no more than 1 of 6 participants experienced a dose-limiting toxicity (DLT) and level immediately below that which had ≥2 instances of DLT. A DLT is an adverse event (AE) observed during the first cycle of treatment that is believed to be related to LY573636 and fulfills any of the following: ET only , Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 hematologic toxicity for ≥3 days; For all, ≥Gr 3 nonhematological toxicity except for nausea/vomiting or diarrhea unless it fits the next criteria; ≥Gr 3 nausea, vomiting, or diarrhea that persists >7 days despite maximal treatment; Gr 3 electrolyte disturbances that persist despite maximal measures; DLT can be declared if a participant experienced increasing toxicity during treatment. The primary outcome measure was not analyzed because the enrollment was stopped early before MTD was reached. | Predose up to 35 days postdose in Cycle 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Area Under the Curve(AUC) of LY573636 Above the Albumin-Corrected Threshold (AUCalb) | LY573636 has been found to be highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) LY573636. PK sample is withdrawn at any time on days 8,14,15,21,28. | Predose,1h,2h,4h, 8d,14d,15d,21d,28d post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon -Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Los Angeles | California | 90095 |
The reasons for discontinuation listed in the participant flow are the reasons the participant discontinued treatment. All participants who received at least 1 dose of study drug were considered to have completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cmax 250 μg/mL (AML) | Participants diagnosed with acute myeloid leukemia (AML) dosed: LY573636 targeting a maximum concentration (Cmax) of 250 micrograms per milliliter (μg/mL) as a 24-hour infusion on Day 1 of a 35-day cycle. |
| FG001 | Cmax 300 μg/mL (AML) | Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 300 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle. |
| FG002 | Cmax 350 μg/mL (AML) | Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 350 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle. |
| FG003 | Cmax 400 μg/mL (AML) | Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 400 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle. |
| FG004 | AUCalb 5500 µg*hr/mL (AML) | Participants diagnosed with AML dosed: LY573636 targeting an albumin-corrected exposure (AUCalb) 5500 micrograms*hour per milliliter (µg*hr/mL) as a 2-hour infusion on Day 1 of a 35-day cycle. |
| FG005 | AUCalb 7000 µg*hr/mL (AML) | Participants diagnosed with AML dosed: LY573636 targeting an AUCalb 7000 µg*hr/mL as a 2-hour infusion on Day 1 of a 35-day cycle. |
| FG006 | AUCalb 5500 µg*hr/mL (ET) | Participants diagnosed with essential thrombocythemia (ET) dosed: LY573636 targeting an AUCalb 5500 µg*hr/mL as a 2-hour infusion on Day 1 of a 28-day cycle. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cmax 250 μg/mL (AML) | Participants diagnosed with acute myeloid leukemia (AML) dosed: LY573636 targeting a maximum concentration (Cmax) of 250 micrograms per milliliter (μg/mL) as a 24-hour infusion on Day 1 of a 35-day cycle. |
| BG001 | Cmax 300 μg/mL (AML) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Recommended Phase 2 Dose of LY573636-Sodium in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) and Essential Thrombocythemia (ET) | Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD is the highest dose at which no more than 1 of 6 participants experienced a dose-limiting toxicity (DLT) and level immediately below that which had ≥2 instances of DLT. A DLT is an adverse event (AE) observed during the first cycle of treatment that is believed to be related to LY573636 and fulfills any of the following: ET only , Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 hematologic toxicity for ≥3 days; For all, ≥Gr 3 nonhematological toxicity except for nausea/vomiting or diarrhea unless it fits the next criteria; ≥Gr 3 nausea, vomiting, or diarrhea that persists >7 days despite maximal treatment; Gr 3 electrolyte disturbances that persist despite maximal measures; DLT can be declared if a participant experienced increasing toxicity during treatment. The primary outcome measure was not analyzed because the enrollment was stopped early before MTD was reached. | No participants were analyzed since the MTD was not reached. | Posted | Predose up to 35 days postdose in Cycle 1 |
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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 | Cmax 250 μg/mL (AML) | Participants diagnosed with acute myeloid leukemia (AML) dosed: LY573636 targeting a maximum concentration (Cmax) of 250 micrograms per milliliter (μg/mL) as a 24-hour infusion on Day 1 of a 35-day cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
The primary outcome measure in this trial was not reached because the enrollment was stopped early before the maximum tolerated dose was reached.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D013920 | Thrombocythemia, Essential |
| D007951 | Leukemia, Myeloid |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C534068 | N-((5-bromo-2-thienyl)sulfonyl)-2,4-dichlorobenzamide |
Not provided
Not provided
Not provided
Not provided
Not provided
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|
|
| Number of Participants With Bone Marrow (BM) Response |
The International Working Group's revised recommendations were used to assess response in acute myeloid leukemia (AML): complete response (CR) is <5% blasts in BM and with a cell count ≥200 cells in BM, and with peripheral blood platelets ≥100x10⁹/liter (L) and absolute neutrophils ≥1x10⁹/L; CR with incomplete blood count recovery is defined as CRi; partial response (PR) is ≥5% blasts in BM but with ≥50% reduction in blast count. Number of responders for AML = CR+PR+ CRi. Result of a European Leukemia Net consensus conference was used to assess response in essential thrombocythemia (ET). CR is platelets ≤400x10⁹/L in peripheral blood, no disease-related symptoms, normal spleen size and white blood cells ≤10x10⁹/L in peripheral blood; PR has platelets ≤600x10⁹/L in peripheral blood or decrease > 50% from baseline but does not meet CR criteria. Number of responders for ET = CR+PR. |
| Baseline to measured progressive disease up to 70 days |
| Pharmacokinetics: Concentration Maximum (Cmax) of LY573636 | PK sample is withdrawn at any time on days 8,14,15,21,28. | Predose,1h,2h,4h, 8d,14d,15d,21d,28d post dose |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aurora | Colorado | 80045 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Baltimore | Maryland | 21287 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Las Vegas | Nevada | 89135 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Houston | Texas | 77030 | United States |
| Death due to Adverse Event |
|
| Death due to Study Drug Toxicity |
|
| Investigator Decision |
|
Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 300 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle. |
| BG002 | Cmax 350 μg/mL (AML) | Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 350 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle. |
| BG003 | Cmax 400 μg/mL (AML) | Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 400 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle. |
| BG004 | AUCalb 5500 µg*hr/mL (AML) | Participants diagnosed with AML dosed: LY573636 targeting an albumin-corrected exposure (AUCalb) 5500 micrograms*hour per milliliter (µg*hr/mL) as a 2-hour infusion on Day 1 of a 35-day cycle. |
| BG005 | AUCalb 7000 µg*hr/mL (AML) | Participants diagnosed with AML dosed: LY573636 targeting an AUCalb 7000 µg*hr/mL as a 2-hour infusion on Day 1 of a 35-day cycle. |
| BG006 | AUCalb 5500 µg*hr/mL (ET) | Participants diagnosed with essential thrombocythemia (ET) dosed: LY573636 targeting an AUCalb 5500 µg*hr/mL as a 2-hour infusion on Day 1 of a 28-day cycle. |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Cmax 250 μg/mL (AML) | Participants diagnosed with acute myeloid leukemia (AML) dosed: LY573636 targeting a maximum concentration (Cmax) of 250 micrograms per milliliter (μg/mL) as a 24-hour infusion on Day 1 of a 35-day cycle. |
| OG001 | Cmax 300 μg/mL (AML) | Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 300 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle. |
| OG002 | Cmax 350 μg/mL (AML) | Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 350 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle. |
| OG003 | Cmax 400 μg/mL (AML) | Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 400 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle. |
| OG004 | AUCalb 5500 µg*hr/mL (AML) | Participants diagnosed with AML dosed: LY573636 targeting an albumin-corrected exposure (AUCalb) 5500 micrograms*hour per milliliter (µg*hr/mL) as a 2-hour infusion on Day 1 of a 35-day cycle. |
| OG005 | AUCalb 7000 µg*hr/mL (AML) | Participants diagnosed with AML dosed: LY573636 targeting an AUCalb 7000 µg*hr/mL as a 2-hour infusion on Day 1 of a 35-day cycle. |
| OG006 | AUCalb 5500 µg*hr/mL (ET) | Participants diagnosed with essential thrombocythemia (ET) dosed: LY573636 targeting an AUCalb 5500 µg*hr/mL as a 2-hour infusion on Day 1 of a 28-day cycle. |
|
| Secondary | Pharmacokinetics Area Under the Curve(AUC) of LY573636 Above the Albumin-Corrected Threshold (AUCalb) | LY573636 has been found to be highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) LY573636. PK sample is withdrawn at any time on days 8,14,15,21,28. | Participants who received the study drug and had pharmacokinetic (PK) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*hour/milliliter (µg*hr/mL) | Predose,1h,2h,4h, 8d,14d,15d,21d,28d post dose |
|
|
|
| Secondary | Number of Participants With Bone Marrow (BM) Response | The International Working Group's revised recommendations were used to assess response in acute myeloid leukemia (AML): complete response (CR) is <5% blasts in BM and with a cell count ≥200 cells in BM, and with peripheral blood platelets ≥100x10⁹/liter (L) and absolute neutrophils ≥1x10⁹/L; CR with incomplete blood count recovery is defined as CRi; partial response (PR) is ≥5% blasts in BM but with ≥50% reduction in blast count. Number of responders for AML = CR+PR+ CRi. Result of a European Leukemia Net consensus conference was used to assess response in essential thrombocythemia (ET). CR is platelets ≤400x10⁹/L in peripheral blood, no disease-related symptoms, normal spleen size and white blood cells ≤10x10⁹/L in peripheral blood; PR has platelets ≤600x10⁹/L in peripheral blood or decrease > 50% from baseline but does not meet CR criteria. Number of responders for ET = CR+PR. | All participants who received at least one dose of the study drug. | Posted | Count of Participants | Participants | No | Baseline to measured progressive disease up to 70 days |
|
|
|
| Secondary | Pharmacokinetics: Concentration Maximum (Cmax) of LY573636 | PK sample is withdrawn at any time on days 8,14,15,21,28. | Participants who received the study drug and had pharmacokinetic (PK) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (µg/mL) | Predose,1h,2h,4h, 8d,14d,15d,21d,28d post dose |
|
|
|
| 3 |
| 3 |
| 3 |
| 3 |
| EG001 | Cmax 300 μg/mL (AML) | Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 300 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle. | 2 | 3 | 3 | 3 |
| EG002 | Cmax 350 μg/mL (AML) | Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 350 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle. | 1 | 3 | 3 | 3 |
| EG003 | Cmax 400 μg/mL (AML) | Participants diagnosed with AML dosed: LY573636 targeting a Cmax of 400 μg/mL as a 24-hour infusion on Day 1 of a 35-day cycle. | 4 | 4 | 4 | 4 |
| EG004 | AUCalb 5500 µg*hr/mL (AML and ET) | Participants diagnosed with AML dosed: LY573636 targeting an albumin-corrected exposure (AUCalb) 5500 micrograms*hour per milliliter (µg*hr/mL) as a 2-hour infusion on Day 1 of a 35-day cycle. Participants diagnosed with essential thrombocythemia (ET) dosed: LY573636 targeting an AUCalb 5500 µg*hr/mL as a 2-hour infusion on Day 1 of a 28-day cycle. | 6 | 9 | 9 | 9 |
| EG005 | AUCalb 7000 µg*hr/mL (AML) | Participants diagnosed with AML dosed: LY573636 targeting an AUCalb 7000 µg*hr/mL as a 2-hour infusion on Day 1 of a 35-day cycle. | 1 | 1 | 1 | 1 |
| Febrile neutropenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | 14.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | 14.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Caecitis | Gastrointestinal disorders | 14.1 | Systematic Assessment | Resulted in a death in the Cmax 400 μg/mL (AML) arm |
|
| Oesophageal pain | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | 14.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | 14.1 | Systematic Assessment |
|
| Cellulitis orbital | Infections and infestations | 14.1 | Systematic Assessment |
|
| Infection | Infections and infestations | 14.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | 14.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | 14.1 | Systematic Assessment | Resulted in 2 deaths in the Cmax 400 μg/mL (AML) arm |
|
| Septic shock | Infections and infestations | 14.1 | Systematic Assessment | Resulted in a death in the Cmax 350 μg/mL (AML) arm and in the Cmax 400 μg/mL |
|
| Staphylococcal sepsis | Infections and infestations | 14.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | 14.1 | Systematic Assessment | Resulted in a death in the AUCalb 5500 µg*hr/mL (AML) arm |
|
| Decreased appetite | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | 14.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | 14.1 | Systematic Assessment | Resulted in a death in the AUCalb 5500 µg*hr/mL (AML) arm |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
|
| Arrhythmia supraventricular | Cardiac disorders | 14.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | 14.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | 14.1 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | 14.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | 14.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | 14.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Anal inflammation | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | 14.1 | Systematic Assessment |
|
| Chest pain | General disorders | 14.1 | Systematic Assessment |
|
| Chills | General disorders | 14.1 | Systematic Assessment |
|
| Fatigue | General disorders | 14.1 | Systematic Assessment |
|
| Inflammatory pain | General disorders | 14.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | 14.1 | Systematic Assessment |
|
| Oedema | General disorders | 14.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | 14.1 | Systematic Assessment |
|
| Therapeutic response unexpected | General disorders | 14.1 | Systematic Assessment |
|
| Ulcer | General disorders | 14.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | 14.1 | Systematic Assessment |
|
| Anal infection | Infections and infestations | 14.1 | Systematic Assessment |
|
| Enterococcal bacteraemia | Infections and infestations | 14.1 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | 14.1 | Systematic Assessment |
|
| Gingival infection | Infections and infestations | 14.1 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | 14.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | 14.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | 14.1 | Systematic Assessment |
|
| Systemic candida | Infections and infestations | 14.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | 14.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | 14.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | 14.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | 14.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | 14.1 | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | 14.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | 14.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | 14.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | 14.1 | Systematic Assessment |
|
| Blood creatinine | Investigations | 14.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | 14.1 | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | 14.1 | Systematic Assessment |
|
| Cardiac murmur | Investigations | 14.1 | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | 14.1 | Systematic Assessment |
|
| Fibrin d dimer increased | Investigations | 14.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | 14.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | 14.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | 14.1 | Systematic Assessment |
|
| Prothrombin time prolonged | Investigations | 14.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | 14.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
|
| Kyphosis | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | 14.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | 14.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | 14.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | 14.1 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | 14.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | 14.1 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | 14.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | 14.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | 14.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | 14.1 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | 14.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | 14.1 | Systematic Assessment |
|
| Vaginal inflammation | Reproductive system and breast disorders | 14.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
|
| Blood blister | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
|
| Subcutaneous nodule | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | 14.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | 14.1 | Systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | 14.1 | Systematic Assessment |
|
Not provided
| D006425 |
| Hemic and Lymphatic Diseases |
| D001778 | Blood Coagulation Disorders |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006474 | Hemorrhagic Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |