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This phase I/II trial is designed to efficiently identify the regimen limiting toxicity (RLT) and recommended phase 2 dose (RP2D) for the combination of the immunotherapeutic agent indoximod when administered in combination with standard of care chemotherapy gemcitabine plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas. All subjects will receive the same standard gemcitabine plus nab-paclitaxel regimen, plus indoximod in doses increasing from 600 mg twice daily to, potentially, 1200 mg twice daily.
This is a Phase I/II trial designed to evaluate the combination of the immunotherapeutic agent indoximod and the standard of care chemotherapy gemcitabine plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas. The phase 1 portion is designed to identify the regimen-limiting toxicity (RLT) and recommended phase 2 dose (RP2D) for the combination. The phase 2 portion of the study will evaluate the potential efficacy of this combination. All subjects will receive the standard 28-day gemcitabine plus nab-paclitaxel regimen. Twice daily oral indoximod will be administered concurrently in continuous 28 day cycles.
In the phase 1 portion, dose escalation of indoximod will begin at 600 mg twice a day and potentially escalate to 1200 mg twice a day. There will be no intra-subject dose escalation. Regimen-limiting toxicity will be considered as those toxicities related to indoximod that significantly limit the administration of the backbone chemotherapy gemcitabine plus nab-paclitaxel. The period for determination of dose-limiting toxicities will be the initial 28 days of treatment. The recommended phase 2 dose will include an assessment of toxicities that occur at later time points.
Once a RP2D is determined, the phase 2 portion of the study will be initiated. In both phase 1 and phase 2, every 2 cycles subjects will have repeat imaging to assess response. Corollary biomarkers will be assessed at the same interval as will PET-CT after the 1st 8 week cycle. Up to 18 patients will be enrolled in the phase 1 portion of the study and 80 patients will be enrolled in the phase 2 portion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indoximod and Gemcitabine + Nab-paclitaxel - Phase 1 | Experimental | Participants received indoximod (600mg, 100mg, or 1200mg according to their assigned dose cohort) PO BID for 28 days concurrently with IV Nab-paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 weekly for 3 weeks with one week rest. Each cycle is 28 days. Patients will continue until they experience disease progression or significant toxicity. |
|
| Indoximod and Gemcitabine + Nab-paclitaxel - Phase 2 | Experimental | Oral indoximod 1200mg BID concurrent with the first backbone chemotherapy cycle. Patients will receive gemcitabine plus nab-paclitaxel on a standard 4 week cycle schedule. Oral indoximod at 1200mg BID will continue throughout. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nab-Paclitaxel | Drug | Nab-Paclitaxel 125 mg/m^2 given intravenously over 30-40 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Regimen Limiting Toxicity | Phase 1 component: To identify the regimen limiting toxicity (RLT) for the combination of the immunotherapeutic agent indoximod when administered in combination with standard of care chemotherapy gemcitabine plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas. RLT will be considered as only grade 3 and 4 toxicities that are attributable to the test agent and result in the delay of the administration of the backbone chemotherapy, gemcitabine plus nab-paclitaxel. | 10 months |
| Overall Survival | Phase 2 component: To evaluate efficacy as determined by overall survival (OS) in patients with metastatic adenocarcinoma of the pancreas. | 22 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | To determine the response rate of the combination indoximod with gemcitabine plus nab-paclitaxel. Imaging assessments to be performed at protocol-specified time points and evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). | 22 months |
| Progression Free Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States | ||
| Augusta University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37534996 | Derived | Beatty GL, Delman D, Yu J, Liu M, Li JH, Zhang L, Lee JW, Chang RB, Bahary N, Kennedy EP, Wang-Gillam A, Rossi GR, Garrido-Laguna I. Treatment Response in First-Line Metastatic Pancreatic Ductal Adenocarcinoma Is Stratified By a Composite Index of Tumor Proliferation and CD8 T-Cell Infiltration. Clin Cancer Res. 2023 Sep 1;29(17):3514-3525. doi: 10.1158/1078-0432.CCR-23-0535. |
| Label | URL |
|---|---|
| Sponsor website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 Dose Level 1 | Participants received 600mg indoximod PO BID for 28 days concurrently with IV Nab-paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 weekly for 3 weeks with one week rest. Each cycle is 28 days. Patients will continue until they experience disease progression or significant toxicity. Nab-Paclitaxel: Nab-Paclitaxel 125 mg/m^2 given intravenously over 30-40 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Gemcitabine: Gemcitabine 1000 mg/m^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jul 25, 2016 |
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| Gemcitabine | Drug | Gemcitabine 1000 mg/m^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. |
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| Indoximod | Drug | Indoximod administered BID by mouth in the form of 200 mg capsules. The medication should be taken twice daily for 28 days each cycle. Patients will continue until they experience disease progression or toxicity. |
|
|
Time to progression with the combination indoximod with gemcitabine plus nab-paclitaxel. Progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). |
| 22 months |
| Augusta |
| Georgia |
| 30912 |
| United States |
| University of Kentucy | Lexington | Kentucky | 40536 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| The Vally Hospital | Paramus | New Jersey | 07652 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Greenville Health Systems | Greenville | South Carolina | 29605 | United States |
| Gibbs Cancer Center and Research Institute | Spartanburg | South Carolina | 29303 | United States |
| The West Clinic | Memphis | Tennessee | 38120 | United States |
| Huntsman Cancer Center | Salt Lake City | Utah | 84112 | United States |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| FG001 | Phase 1 Dose Level 2 | Participants received 1000mg indoximod PO BID for 28 days concurrently with IV Nab-paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 weekly for 3 weeks with one week rest. Each cycle is 28 days. Patients will continue until they experience disease progression or significant toxicity. Nab-Paclitaxel: Nab-Paclitaxel 125 mg/m^2 given intravenously over 30-40 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Gemcitabine: Gemcitabine 1000 mg/m^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. |
| FG002 | Phase 1 Dose Level 3 | Participants received 1200mg indoximod PO BID for 28 days concurrently with IV Nab-paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 weekly for 3 weeks with one week rest. Each cycle is 28 days. Patients will continue until they experience disease progression or significant toxicity. Nab-Paclitaxel: Nab-Paclitaxel 125 mg/m^2 given intravenously over 30-40 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Gemcitabine: Gemcitabine 1000 mg/m^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. |
| FG003 | Indoximod and Gemcitabine + Nab-paclitaxel - Phase 2 | Oral indoximod 1200mg BID concurrent with the first backbone chemotherapy cycle. Patients will receive gemcitabine plus nab-paclitaxel on a standard 4 week cycle schedule. Oral indoximod at 1200mg BID will continue throughout. Nab-Paclitaxel: Nab-Paclitaxel 125 mg/m^2 given intravenously over 30-40 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Gemcitabine: Gemcitabine 1000 mg/m^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Indoximod: Indoximod administered BID by mouth in the form of 200 mg capsules. The medication should be taken twice daily for 28 days each cycle. Patients will continue until they experience disease progression or toxicity. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 Dose Level 1 | Participants received indoximod 600mg PO BID for 28 days concurrently with IV Nab-paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 weekly for 3 weeks with one week rest. Each cycle is 28 days. Patients will continue until they experience disease progression or significant toxicity. Nab-Paclitaxel: Nab-Paclitaxel 125 mg/m^2 given intravenously over 30-40 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Gemcitabine: Gemcitabine 1000 mg/m^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Indoximod: Indoximod administered BID by mouth in the form of 200 mg capsules. The medication should be taken twice daily for 28 days each cycle. Patients will continue until they experience disease progression or toxicity. |
| BG001 | Phase 1 Dose Level 2 | Participants received indoximod 1000mg PO BID for 28 days concurrently with IV Nab-paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 weekly for 3 weeks with one week rest. Each cycle is 28 days. Patients will continue until they experience disease progression or significant toxicity. Nab-Paclitaxel: Nab-Paclitaxel 125 mg/m^2 given intravenously over 30-40 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Gemcitabine: Gemcitabine 1000 mg/m^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Indoximod: Indoximod administered BID by mouth in the form of 200 mg capsules. The medication should be taken twice daily for 28 days each cycle. Patients will continue until they experience disease progression or toxicity. |
| BG002 | Phase 1 Dose Level 3 | Participants received indoximod 1200mg PO BID for 28 days concurrently with IV Nab-paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 weekly for 3 weeks with one week rest. Each cycle is 28 days. Patients will continue until they experience disease progression or significant toxicity. Nab-Paclitaxel: Nab-Paclitaxel 125 mg/m^2 given intravenously over 30-40 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Gemcitabine: Gemcitabine 1000 mg/m^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Indoximod: Indoximod administered BID by mouth in the form of 200 mg capsules. The medication should be taken twice daily for 28 days each cycle. Patients will continue until they experience disease progression or toxicity. |
| BG003 | Indoximod and Gemcitabine + Nab-paclitaxel - Phase 2 | Oral indoximod 1200mg BID concurrent with the first backbone chemotherapy cycle. Patients will receive gemcitabine plus nab-paclitaxel on a standard 4 week cycle schedule. Oral indoximod at 1200mg BID will continue throughout. Nab-Paclitaxel: Nab-Paclitaxel 125 mg/m^2 given intravenously over 30-40 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Gemcitabine: Gemcitabine 1000 mg/m^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Indoximod: Indoximod administered BID by mouth in the form of 200 mg capsules. The medication should be taken twice daily for 28 days each cycle. Patients will continue until they experience disease progression or toxicity. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | Kilograms |
| |||||||||||||||
| Height | Mean | Standard Deviation | centimeters |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m2 |
| |||||||||||||||
| BSA | Mean | Standard Deviation | m^2 |
| |||||||||||||||
| Baseline ECOG Performance Status | 1] Measure Description: ECOG PERFORMANCE STATUS. Lower grade = better outcome. GRADE: 0=Fully active, able to carry on all pre-disease performance without restriction
| Mean | Standard Deviation | units on a scale |
|
| 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 | Regimen Limiting Toxicity | Phase 1 component: To identify the regimen limiting toxicity (RLT) for the combination of the immunotherapeutic agent indoximod when administered in combination with standard of care chemotherapy gemcitabine plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas. RLT will be considered as only grade 3 and 4 toxicities that are attributable to the test agent and result in the delay of the administration of the backbone chemotherapy, gemcitabine plus nab-paclitaxel. | Posted | Count of Participants | Participants | 10 months |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Overall Survival | Phase 2 component: To evaluate efficacy as determined by overall survival (OS) in patients with metastatic adenocarcinoma of the pancreas. | Posted | Median | 95% Confidence Interval | Weeks | 22 months |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Response Rate | To determine the response rate of the combination indoximod with gemcitabine plus nab-paclitaxel. Imaging assessments to be performed at protocol-specified time points and evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). | Posted | Count of Participants | Participants | 22 months |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival | Time to progression with the combination indoximod with gemcitabine plus nab-paclitaxel. Progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). | Posted | Median | 95% Confidence Interval | Weeks | 22 months |
|
|
Adverse events were captured from the first dose of study drug through study completion up to 26 months.
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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 1 Dose Level 1 | Participants received indoximod 600mg PO BID for 28 days concurrently with IV Nab-paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 weekly for 3 weeks with one week rest. Each cycle is 28 days. Patients will continue until they experience disease progression or significant toxicity. Nab-Paclitaxel: Nab-Paclitaxel 125 mg/m^2 given intravenously over 30-40 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Gemcitabine: Gemcitabine 1000 mg/m^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Indoximod: Indoximod administered BID by mouth in the form of 200 mg capsules. The medication should be taken twice daily for 28 days each cycle. Patients will continue until they experience disease progression or toxicity. | 1 | 6 | 2 | 6 | 6 | 6 |
| EG001 | Phase 1 Dose Level 2 | Participants received indoximod 1000mg PO BID for 28 days concurrently with IV Nab-paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 weekly for 3 weeks with one week rest. Each cycle is 28 days. Patients will continue until they experience disease progression or significant toxicity. Nab-Paclitaxel: Nab-Paclitaxel 125 mg/m^2 given intravenously over 30-40 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Gemcitabine: Gemcitabine 1000 mg/m^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Indoximod: Indoximod administered BID by mouth in the form of 200 mg capsules. The medication should be taken twice daily for 28 days each cycle. Patients will continue until they experience disease progression or toxicity. | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | Phase 1 Dose Level 3 | Participants received indoximod 1200mg PO BID for 28 days concurrently with IV Nab-paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 weekly for 3 weeks with one week rest. Each cycle is 28 days. Patients will continue until they experience disease progression or significant toxicity. Nab-Paclitaxel: Nab-Paclitaxel 125 mg/m^2 given intravenously over 30-40 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Gemcitabine: Gemcitabine 1000 mg/m^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Indoximod: Indoximod administered BID by mouth in the form of 200 mg capsules. The medication should be taken twice daily for 28 days each cycle. Patients will continue until they experience disease progression or toxicity. | 0 | 6 | 3 | 6 | 6 | 6 |
| EG003 | Indoximod and Gemcitabine + Nab-paclitaxel - Phase 2 | Oral indoximod 1200mg BID concurrent with the first backbone chemotherapy cycle. Patients will receive gemcitabine plus nab-paclitaxel on a standard 4 week cycle schedule. Oral indoximod at 1200mg BID will continue throughout. Nab-Paclitaxel: Nab-Paclitaxel 125 mg/m^2 given intravenously over 30-40 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Gemcitabine: Gemcitabine 1000 mg/m^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity. Indoximod: Indoximod administered BID by mouth in the form of 200 mg capsules. The medication should be taken twice daily for 28 days each cycle. Patients will continue until they experience disease progression or toxicity. | 9 | 135 | 84 | 135 | 135 | 135 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pancytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Duodenal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Duodenitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal necrosis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Obstruction gastric | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rectal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small intestinal perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Oedema | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Mucosal inflammation | General disorders | Systematic Assessment |
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| Sudden death | General disorders | Systematic Assessment |
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| Influenza like illness | General disorders | Systematic Assessment |
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| Bile duct obstruction | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cholangitis | Hepatobiliary disorders | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hyperbilirubinaemia | Hepatobiliary disorders | Systematic Assessment |
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| Jaundice cholestatic | Hepatobiliary disorders | Systematic Assessment |
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| Liver injury | Hepatobiliary disorders | Systematic Assessment |
| ||
| Drug hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Abdominal infection | Infections and infestations | Systematic Assessment |
| ||
| Bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile colitis | Infections and infestations | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Pancreatic abscess | Infections and infestations | Systematic Assessment |
| ||
| Osteomyelitis | Infections and infestations | Systematic Assessment |
| ||
| Streptococcal infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Femoral neck fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Cognitive disorder | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Ischaemic stroke | Nervous system disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Hydronephrosis | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Interstitial lung disease | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Embolism | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pancytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Coagulopathy | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Haemolytic uraemic syndrome | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Splenic vein thrombosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Diastolic dysfunction | Cardiac disorders | Systematic Assessment |
| ||
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Aortic valve stenosis | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
| ||
| Left ventricular dysfunction | Cardiac disorders | Systematic Assessment |
| ||
| Mitral valve incompetence | Cardiac disorders | Systematic Assessment |
| ||
| Mitral valve sclerosis | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Tricuspid valve incompetence | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Ear congestion | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Ear haemorrhage | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Hypoacusis | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Vision blurred | Eye disorders | Systematic Assessment |
| ||
| Visual impairment | Eye disorders | Systematic Assessment |
| ||
| Lacrimation increased | Eye disorders | Systematic Assessment |
| ||
| Dry eye | Eye disorders | Systematic Assessment |
| ||
| Eye pain | Eye disorders | Systematic Assessment |
| ||
| Eyelid haematoma | Eye disorders | Systematic Assessment |
| ||
| Keratitis | Eye disorders | Systematic Assessment |
| ||
| Periorbital oedema | Eye disorders | Systematic Assessment |
| ||
| Photopsia | Eye disorders | Systematic Assessment |
| ||
| Retinal disorder | Eye disorders | Systematic Assessment |
| ||
| Scleral disorder | Eye disorders | Systematic Assessment |
| ||
| Subretinal fluid | Eye disorders | Systematic Assessment |
| ||
| Vitreous floaters | Eye disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rectal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haematemesis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haematochezia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oral pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chapped lips | Gastrointestinal disorders | Systematic Assessment |
| ||
| Duodenal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Duodenitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Erosive oesophagitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Eructation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Faeces discoloured | Gastrointestinal disorders | Systematic Assessment |
| ||
| Faeces pale | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastric ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal necrosis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hiatus hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Melaena | Gastrointestinal disorders | Systematic Assessment |
| ||
| Obstruction gastric | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oesophagitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Retroperitoneum cyst | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small intestinal perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Oedema | General disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Peripheral swelling | General disorders | Systematic Assessment |
| ||
| Mucosal inflammation | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Localised oedema | General disorders | Systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Systematic Assessment |
| ||
| Generalised oedema | General disorders | Systematic Assessment |
| ||
| Malaise | General disorders | Systematic Assessment |
| ||
| Gait disturbance | General disorders | Systematic Assessment |
| ||
| Sudden death | General disorders | Systematic Assessment |
| ||
| Tenderness | General disorders | Systematic Assessment |
| ||
| Chest discomfort | General disorders | Systematic Assessment |
| ||
| Cyst | General disorders | Systematic Assessment |
| ||
| Discomfort | General disorders | Systematic Assessment |
| ||
| Face oedema | General disorders | Systematic Assessment |
| ||
| Feeling hot | General disorders | Systematic Assessment |
| ||
| Hypothermia | General disorders | Systematic Assessment |
| ||
| Local swelling | General disorders | Systematic Assessment |
| ||
| Medical device site pain | General disorders | Systematic Assessment |
| ||
| Swelling | General disorders | Systematic Assessment |
| ||
| Thirst | General disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Influenza like illness | General disorders | Systematic Assessment |
| ||
| Cholangitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hyperbilirubinaemia | Hepatobiliary disorders | Systematic Assessment |
| ||
| Portal vein thrombosis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Bile duct obstruction | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cholecystitis acute | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatic failure | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatomegaly | Hepatobiliary disorders | Systematic Assessment |
| ||
| Jaundice | Hepatobiliary disorders | Systematic Assessment |
| ||
| Jaundice cholestatic | Hepatobiliary disorders | Systematic Assessment |
| ||
| Liver injury | Hepatobiliary disorders | Systematic Assessment |
| ||
| Portal hypertension | Hepatobiliary disorders | Systematic Assessment |
| ||
| Portal vein occlusion | Hepatobiliary disorders | Systematic Assessment |
| ||
| Drug hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Seasonal allergy | Immune system disorders | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Skin infection | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
| ||
| Oral candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Candida infection | Infections and infestations | Systematic Assessment |
| ||
| Folliculitis | Infections and infestations | Systematic Assessment |
| ||
| Fungal infection | Infections and infestations | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Nail infection | Infections and infestations | Systematic Assessment |
| ||
| Rhinitis | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Viral upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Abdominal infection | Infections and infestations | Systematic Assessment |
| ||
| Bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile colitis | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile infection | Infections and infestations | Systematic Assessment |
| ||
| Conjunctivitis | Infections and infestations | Systematic Assessment |
| ||
| Device related infection | Infections and infestations | Systematic Assessment |
| ||
| Enterocolitis infectious | Infections and infestations | Systematic Assessment |
| ||
| Escherichia urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Hepatic infection | Infections and infestations | Systematic Assessment |
| ||
| Laryngitis | Infections and infestations | Systematic Assessment |
| ||
| Mucosal infection | Infections and infestations | Systematic Assessment |
| ||
| Oesophageal infection | Infections and infestations | Systematic Assessment |
| ||
| Oral herpes | Infections and infestations | Systematic Assessment |
| ||
| Osteomyelitis | Infections and infestations | Systematic Assessment |
| ||
| Pancreatic abscess | Infections and infestations | Systematic Assessment |
| ||
| Paronychia | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis streptococcal | Infections and infestations | Systematic Assessment |
| ||
| Staphylococcal infection | Infections and infestations | Systematic Assessment |
| ||
| Streptococcal infection | Infections and infestations | Systematic Assessment |
| ||
| Tooth infection | Infections and infestations | Systematic Assessment |
| ||
| Vaginal infection | Infections and infestations | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Arthropod bite | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Femoral neck fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| White blood cell count decreased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
| ||
| Weight decreased | Investigations | Systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| C-reactive protein increased | Investigations | Systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Systematic Assessment |
| ||
| Blood sodium decreased | Investigations | Systematic Assessment |
| ||
| Blood albumin decreased | Investigations | Systematic Assessment |
| ||
| Blood potassium decreased | Investigations | Systematic Assessment |
| ||
| White blood cell count increased | Investigations | Systematic Assessment |
| ||
| Haemoglobin decreased | Investigations | Systematic Assessment |
| ||
| Platelet count increased | Investigations | Systematic Assessment |
| ||
| Blood creatine increased | Investigations | Systematic Assessment |
| ||
| Ammonia increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase decreased | Investigations | Systematic Assessment |
| ||
| Blood alkaline phosphatase | Investigations | Systematic Assessment |
| ||
| Blood bilirubin | Investigations | Systematic Assessment |
| ||
| Blood calcium decreased | Investigations | Systematic Assessment |
| ||
| Blood chloride decreased | Investigations | Systematic Assessment |
| ||
| Blood glucose increased | Investigations | Systematic Assessment |
| ||
| Blood iron decreased | Investigations | Systematic Assessment |
| ||
| Blood potassium increased | Investigations | Systematic Assessment |
| ||
| Blood pressure systolic increased | Investigations | Systematic Assessment |
| ||
| Blood thyroid stimulating hormone increased | Investigations | Systematic Assessment |
| ||
| Blood triglycerides increased | Investigations | Systematic Assessment |
| ||
| Blood urea increased | Investigations | Systematic Assessment |
| ||
| Carbohydrate antigen 19-9 | Investigations | Systematic Assessment |
| ||
| Carbohydrate antigen 19-9 increased | Investigations | Systematic Assessment |
| ||
| Carcinoembryonic antigen | Investigations | Systematic Assessment |
| ||
| Carcinoembryonic antigen increased | Investigations | Systematic Assessment |
| ||
| Creatinine renal clearance increased | Investigations | Systematic Assessment |
| ||
| Eastern Cooperative Oncology Group Perfomance Status | Investigations | Systematic Assessment |
| ||
| Ejection fraction decreased | Investigations | Systematic Assessment |
| ||
| International normalised ratio increased | Investigations | Systematic Assessment |
| ||
| Transaminases increased | Investigations | Systematic Assessment |
| ||
| Troponin increased | Investigations | Systematic Assessment |
| ||
| Vitamin D decreased | Investigations | Systematic Assessment |
| ||
| Decreased appetite | Investigations | Systematic Assessment |
| ||
| Dehydration | Investigations | Systematic Assessment |
| ||
| Hyponatraemia | Investigations | Systematic Assessment |
| ||
| Hypoalbuminaemia | Investigations | Systematic Assessment |
| ||
| Hypokalaemia | Investigations | Systematic Assessment |
| ||
| Hypocalcaemia | Investigations | Systematic Assessment |
| ||
| Hyperglycaemia | Investigations | Systematic Assessment |
| ||
| Hyperkalaemia | Investigations | Systematic Assessment |
| ||
| Hypomagnesaemia | Investigations | Systematic Assessment |
| ||
| Hypoglycaemia | Investigations | Systematic Assessment |
| ||
| Hypercalcaemia | Investigations | Systematic Assessment |
| ||
| Malnutrition | Investigations | Systematic Assessment |
| ||
| Metabolic acidosis | Investigations | Systematic Assessment |
| ||
| Diabetes mellitus | Investigations | Systematic Assessment |
| ||
| Gout | Investigations | Systematic Assessment |
| ||
| Hyperlipidaemia | Investigations | Systematic Assessment |
| ||
| Hyperuricaemia | Investigations | Systematic Assessment |
| ||
| Lactose intolerance | Investigations | Systematic Assessment |
| ||
| Polydipsia | Investigations | Systematic Assessment |
| ||
| Iron deficiency | Investigations | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Joint swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Vertigo | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neuropathy peripheral | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Aphasia | Nervous system disorders | Systematic Assessment |
| ||
| Lethargy | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral motor neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Posterior reversible encephalopathy syndrome | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Ataxia | Nervous system disorders | Systematic Assessment |
| ||
| Carpal tunnel syndrome | Nervous system disorders | Systematic Assessment |
| ||
| Cognitive disorder | Nervous system disorders | Systematic Assessment |
| ||
| Disturbance in attention | Nervous system disorders | Systematic Assessment |
| ||
| Dyskinesia | Nervous system disorders | Systematic Assessment |
| ||
| Hemiparesis | Nervous system disorders | Systematic Assessment |
| ||
| Hyperaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Ischaemic stroke | Nervous system disorders | Systematic Assessment |
| ||
| Memory impairment | Nervous system disorders | Systematic Assessment |
| ||
| Sciatica | Nervous system disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
| ||
| Visual field defect | Nervous system disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Confusional state | Psychiatric disorders | Systematic Assessment |
| ||
| Hallucination | Psychiatric disorders | Systematic Assessment |
| ||
| Irritability | Psychiatric disorders | Systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Mental status changes | Psychiatric disorders | Systematic Assessment |
| ||
| Dysphoria | Psychiatric disorders | Systematic Assessment |
| ||
| Nightmare | Nervous system disorders | Systematic Assessment |
| ||
| Restlessness | Psychiatric disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Dysuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Pollakiuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Chromaturia | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Hydronephrosis | Renal and urinary disorders | Systematic Assessment |
| ||
| Incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal cyst | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary tract pain | Renal and urinary disorders | Systematic Assessment |
| ||
| Breast swelling | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Erectile dysfunction | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Scrotal oedema | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vaginal haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vulval disorder | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Vasomotor rhinitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Night sweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin disorder | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Nail discolouration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Decubitus ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Nail disorder | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin discolouration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Miliaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Nodular rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Onycholysis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pain of skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pigmentation disorder | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash generalised | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin exfoliation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Embolism | Vascular disorders | Systematic Assessment |
| ||
| Flushing | Vascular disorders | Systematic Assessment |
| ||
| Haematoma | Vascular disorders | Systematic Assessment |
| ||
| Hot flush | Vascular disorders | Systematic Assessment |
| ||
| Lymphoedema | Vascular disorders | Systematic Assessment |
| ||
| Phlebitis | Vascular disorders | Systematic Assessment |
| ||
| Thrombophlebitis superficial | Vascular disorders | Systematic Assessment |
| ||
| Arterial occlusive disease | Vascular disorders | Systematic Assessment |
| ||
| Haemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Infarction | Vascular disorders | Systematic Assessment |
| ||
| Orthostatic hypotension | Vascular disorders | Systematic Assessment |
| ||
| Subclavian vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Cystitis | Infections and infestations | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lumos Pharma, Inc. | Lumos Pharma, Inc. | 515-598-2921 | clinical.trials@lumos-pharma.com |
| Mar 6, 2024 |
| Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2019 | Sep 14, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D017239 | Paclitaxel |
| D000093542 | Gemcitabine |
| C525396 | 1-methyltryptophan |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
|
|
|