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A first-in-human, Phase 1, open-label, multicenter study of WTX-330 administered as a monotherapy to patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma.
This is a first-in-human, Phase 1, open-label, multicenter study to evaluate the safety, tolerability and preliminary efficacy of WTX-330, a conditionally-activated IL-12 prodrug, when administered as a monotherapy to patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma. Dose escalation will be conducted in patients with advanced and/or metastatic solid tumors who are refractory to all standard of care therapies. Dose expansion will be conducted in two arms: Arm A will enroll patients with indications for which a checkpoint inhibitor (CPI) is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1 treatment regimen, and Arm B will enroll patients with tumor types for which CPI therapy is not indicated/approved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WTX-330 dose escalation | Experimental | Patients with relapsed/refractory advanced or metastatic solid tumors |
|
| WTX-330 dose expansion in patients for whom CPI therapy is indicated (Arm A) | Experimental | WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen |
|
| WTX-330 dose expansion in patients for whom CPI therapy is not indicated (Arm B) | Experimental | WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WTX-330 | Drug | Investigation Product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicities (DLTs) | A DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle of treatment with WTX-330 and meets any of the criteria included in the protocol | 4 weeks |
| Incidence of Treatment Emergent Adverse Events | AEs were graded and documented in accordance with NCI-CTCAE version 5.0 | 24 months |
| Incidence of Changes in Clinical Laboratory Abnormalities | Change from baseline is provided as baseline grade or "normal/low/high" and worst post-baseline grade. | 24 months |
| Investigator-assessed Objective Response Rate (ORR) by RECIST 1.1 and Immune ORR by iRECIST (for Solid Tumors) or Response by Lugano Criteria (for Lymphomas) | RECIST = Response Evaluation Criteria in Solid Tumors | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of WTX-330 Cycle 1 - C Max | PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 |
| Plasma Concentrations of WTX-330 Cycle 1 - Time of Maximum Concentration Observation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth | Scottsdale | Arizona | 85258 | United States | ||
| Emory Winship Cancer Institute of Emory University |
36 potential participants underwent screening, 11 were screened out, and 25 were included in the trial.
Participants were recruited based on their oncological history at 9 clinical research sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | WTX-330 Dose Escalation - 0.016 mg/kg | Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle |
| FG001 | WTX-330 Dose Escalation - 0.024 mg/kg |
| 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 | Yes | No | No | Study Protocol | Apr 6, 2023 | Sep 22, 2025 |
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PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 |
| 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 |
| Plasma Concentrations of WTX-330 Cycle 1 - Half Life | PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 |
| Plasma Concentrations of WTX-330 Cycle 1 - AUC | PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose. | 14 days |
| Plasma Concentrations of WTX-330 Cycle 2 - C Max | PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 |
| Plasma Concentrations of WTX-330 Cycle 2 - Time of Maximum Concentration Observation | PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 |
| Plasma Concentrations of WTX-330 Cycle 2 - Half Life | PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 |
| Plasma Concentrations of WTX-330 Cycle 2 - AUC | PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose. | 14 days |
| Plasma Concentrations of IL-12 Cycle 1 - C Max | PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 |
| Plasma Concentrations of IL-12 Cycle 1 - Time of Maximum Concentration Observation | PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 |
| Plasma Concentrations of IL-12 Cycle 1 - Half Life | PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 |
| Plasma Concentrations of IL-12 Cycle 1 - AUC | PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose. | 14 days |
| Plasma Concentrations of IL-12 Cycle 2 - C Max | PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 |
| Plasma Concentrations of IL-12 Cycle 2 - Time of Maximum Concentration Observation | PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 |
| Plasma Concentrations of IL-12 Cycle 2 - Half Life | PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 |
| Plasma Concentrations of IL-12 Cycle 2 - AUC | PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose. | 14 days |
| Antidrug Antibody (ADA) Occurrence | ADA were measured at Baseline and Post Baseline. "Positive" post baseline applies if at least one post-baseline value was positive. | 24 months |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Mass General Hospital | Boston | Massachusetts | 02114 | United States |
| Facility Name: Roswell Park Comprehensive Cancer Care | Buffalo | New York | 14203 | United States |
| Providence Cancer Institute Franz Clinic | Portland | Oregon | 97213 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| NEXT Oncology | San Antonio | Texas | 78229 | United States |
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle |
| FG002 | WTX-330 Dose Escalation - 0.032 mg/kg | Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle |
| FG003 | WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A); 0.024 mg/kg | WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen. Expansion Dose was 0.024 mg/kg. |
| FG004 | WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B); 0.024 mg/kg | WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved. Expansion Dose was 0.024 mg/kg. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | WTX-330 Dose Escalation - 0.016 mg/kg | Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle |
| BG001 | WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A); 0.024 mg/kg | WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen |
| BG002 | WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B); 0.024 mg/kg | WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved |
| BG003 | WTX-330 Dose Escalation - 0.024 mg/kg | Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle |
| BG004 | WTX-330 Dose Escalation - 0.032 mg/kg | Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle |
| BG005 | 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 |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Dose Limiting Toxicities (DLTs) | A DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle of treatment with WTX-330 and meets any of the criteria included in the protocol | Posted | Count of Participants | Participants | 4 weeks |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Incidence of Treatment Emergent Adverse Events | AEs were graded and documented in accordance with NCI-CTCAE version 5.0 | Safety Analysis Set included all participants | Posted | Count of Participants | Participants | 24 months |
| ||||||||||||||||||||||||||||||||||
| Primary | Incidence of Changes in Clinical Laboratory Abnormalities | Change from baseline is provided as baseline grade or "normal/low/high" and worst post-baseline grade. | Posted | Count of Participants | Participants | 24 months |
| |||||||||||||||||||||||||||||||||||
| Primary | Investigator-assessed Objective Response Rate (ORR) by RECIST 1.1 and Immune ORR by iRECIST (for Solid Tumors) or Response by Lugano Criteria (for Lymphomas) | RECIST = Response Evaluation Criteria in Solid Tumors | The overall number of participants analyzed is lower than the overall study population, as the efficacy evaluable analysis set does not include all enrolled participants | Posted | Number | 95% Confidence Interval | Percent of participants | 24 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of WTX-330 Cycle 1 - C Max | PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 | Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. | Posted | Mean | Standard Deviation | mcg/ml | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of WTX-330 Cycle 1 - Time of Maximum Concentration Observation | PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 | Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. | Posted | Mean | Standard Deviation | h | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of WTX-330 Cycle 1 - Half Life | PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 | Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. | Posted | Mean | Standard Deviation | day | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of WTX-330 Cycle 1 - AUC | PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose. | Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. | Posted | Mean | Standard Deviation | day*mcg/ml | 14 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of WTX-330 Cycle 2 - C Max | PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 | Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. Overall Number of Participants Analyzed is lower for cycle 2, as not all participants continued on study and not all samples were available. | Posted | Mean | Standard Deviation | mcg/ml | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of WTX-330 Cycle 2 - Time of Maximum Concentration Observation | PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 | Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. Overall Number of Participants Analyzed is lower for cycle 2, as not all participants continued on study and not all samples were available. | Posted | Mean | Standard Deviation | h | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of WTX-330 Cycle 2 - Half Life | PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 | Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. Overall Number of Participants Analyzed is lower for cycle 2, as not all participants continued on study and not all samples were available. | Posted | Mean | Standard Deviation | day | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of WTX-330 Cycle 2 - AUC | PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose. | Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. Overall Number of Participants Analyzed is lower for cycle 2, as not all participants continued on study and not all samples were available. | Posted | Mean | Standard Deviation | day*mcg/ml | 14 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of IL-12 Cycle 1 - C Max | PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 | Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. | Posted | Mean | Standard Deviation | pg/ml | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of IL-12 Cycle 1 - Time of Maximum Concentration Observation | PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 | Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. | Posted | Mean | Standard Deviation | h | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of IL-12 Cycle 1 - Half Life | PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 | Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. | Posted | Mean | Standard Deviation | day | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of IL-12 Cycle 1 - AUC | PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose. | Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. | Posted | Mean | Standard Deviation | day*pg/ml | 14 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of IL-12 Cycle 2 - C Max | PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 | Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. Overall Number of Participants Analyzed is lower for cycle 2, as not all participants continued on study and not all samples were available. | Posted | Mean | Standard Deviation | pg/ml | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of IL-12 Cycle 2 - Time of Maximum Concentration Observation | PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 | Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. Overall Number of Participants Analyzed is lower for cycle 2, as not all participants continued on study and not all samples were available. | Posted | Mean | Standard Deviation | h | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of IL-12 Cycle 2 - Half Life | PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 | Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. Overall Number of Participants Analyzed is lower for cycle 2, as not all participants continued on study and not all samples were available. | Posted | Mean | Standard Deviation | day | 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2 |
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of IL-12 Cycle 2 - AUC | PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose. | Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. Overall Number of Participants Analyzed is lower for cycle 2, as not all participants continued on study and not all samples were available. | Posted | Mean | Standard Deviation | day*pg/ml | 14 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Antidrug Antibody (ADA) Occurrence | ADA were measured at Baseline and Post Baseline. "Positive" post baseline applies if at least one post-baseline value was positive. | Posted | Count of Participants | Participants | 24 months |
|
AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | WTX-330 Dose Escalation - 0.016 mg/kg | Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle | 0 | 3 | 0 | 3 | 3 | 3 |
| EG001 | WTX-330 Dose Escalation - 0.024 mg/kg | Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | WTX-330 Dose Escalation - 0.032 mg/kg | Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle | 0 | 5 | 2 | 5 | 5 | 5 |
| EG003 | WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A); 0.024 mg/kg | WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen | 3 | 5 | 3 | 5 | 5 | 5 |
| EG004 | WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B); 0.024 mg/kg | WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved | 5 | 9 | 8 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cytokine release syndrome | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Adrenocortical insufficiency acute | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Malignant melanoma of sites other than skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Adrenocortical insufficiency acute | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Ammonia increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Aspartate aminotransferase | Investigations | MedDRA | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Cortisol decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Respiratory rate increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Sacral pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Malignant melanoma of sites other than skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Testicular swelling | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Wound drainage | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Werewolf Study Director | Werewolf Therapeutics | 617-675-1865 | clinicaltrials@werewolftx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 26, 2025 | Sep 22, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
| OG004 | WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B) | WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved |
|
|
| OG004 | WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B) | WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved |
|
|
| OG003 |
| WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A); 0.024 mg/kg |
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen |
| OG004 | WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B); 0.024 mg/kg | WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved |
|
|
| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Participants |
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| Units | Counts |
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| Participants |
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|
|
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
| OG004 | WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B); 0.024 mg/kg | WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved |
|
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| Missing |
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| Low - Grade 0 |
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| Normal - Grade 0 |
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| Normal - Grade 1 |
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| Normal - Grade 2 |
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| Normal - Grade 3 |
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| High - Grade 0 |
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| High - Grade 1 |
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| High - Grade 2 |
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| High - Grade 3 |
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| Grade 0 - Grade 1 |
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| Grade 1 - Grade 0 |
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| Grade 2 - Grade 0 |
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| Grade 4 - Grade 4 |
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| Grade 0 - Grade 4 |
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| Grade 1 - Grade 4 |
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| Grade 2 - Grade 4 |
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| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
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| Normal - Grade 0 |
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| Normal - Grade 1 |
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| Normal - Grade 2 |
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| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
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| High - Grade 3 |
|
| Grade 0 - Grade 1 |
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| Grade 0 - Grade 2 |
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| Grade 0 - Grade 3 |
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| Grade 1 - Grade 0 |
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| Grade 1 - Grade 1 |
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| Grade 1 - Grade 2 |
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| Grade 1 - Grade 3 |
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| Grade 2 - Grade 0 |
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| Grade 2 - Grade 1 |
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| Grade 2 - Grade 2 |
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| Grade 2 - Grade 3 |
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| Grade 3 - Grade 0 |
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| Grade 3 - Grade 1 |
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| Grade 3 - Grade 2 |
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| Grade 3 - Grade 3 |
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| Grade 4 - Grade 0 |
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| Grade 4 - Grade 1 |
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| Grade 4 - Grade 2 |
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| Grade 4 - Grade 3 |
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| Grade 4 - Grade 4 |
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| Grade 0 - Grade 4 |
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| Grade 1 - Grade 4 |
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| Grade 2 - Grade 4 |
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| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
|
| Normal - Grade 0 |
|
| Normal - Grade 1 |
|
| Normal - Grade 2 |
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| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
|
| High - Grade 3 |
|
| Grade 0 - Grade 1 |
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| Grade 0 - Grade 2 |
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| Grade 0 - Grade 3 |
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| Grade 1 - Grade 0 |
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| Grade 1 - Grade 1 |
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| Grade 1 - Grade 2 |
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| Grade 1 - Grade 3 |
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| Grade 2 - Grade 0 |
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| Grade 2 - Grade 1 |
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| Grade 2 - Grade 2 |
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| Grade 2 - Grade 3 |
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| Grade 3 - Grade 0 |
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| Grade 3 - Grade 1 |
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| Grade 3 - Grade 2 |
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| Grade 3 - Grade 3 |
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| Grade 4 - Grade 0 |
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| Grade 4 - Grade 1 |
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| Grade 4 - Grade 2 |
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| Grade 4 - Grade 3 |
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| Grade 4 - Grade 4 |
|
| Grade 0 - Grade 4 |
|
| Grade 1 - Grade 4 |
|
| Grade 2 - Grade 4 |
|
| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
|
| Normal - Grade 0 |
|
| Normal - Grade 1 |
|
| Normal - Grade 2 |
|
| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
|
| High - Grade 3 |
|
| Grade 0 - Grade 1 |
|
| Grade 0 - Grade 2 |
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| Grade 0 - Grade 3 |
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| Grade 1 - Grade 0 |
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| Grade 1 - Grade 1 |
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| Grade 1 - Grade 2 |
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| Grade 1 - Grade 3 |
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| Grade 2 - Grade 0 |
|
| Grade 2 - Grade 1 |
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| Grade 2 - Grade 2 |
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| Grade 2 - Grade 3 |
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| Grade 3 - Grade 0 |
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| Grade 3 - Grade 1 |
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| Grade 3 - Grade 2 |
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| Grade 3 - Grade 3 |
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| Grade 4 - Grade 0 |
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| Grade 4 - Grade 1 |
|
| Grade 4 - Grade 2 |
|
| Grade 4 - Grade 3 |
|
| Grade 4 - Grade 4 |
|
| Grade 0 - Grade 4 |
|
| Grade 1 - Grade 4 |
|
| Grade 2 - Grade 4 |
|
| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
|
| Normal - Grade 0 |
|
| Normal - Grade 1 |
|
| Normal - Grade 2 |
|
| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
|
| High - Grade 3 |
|
| Grade 0 - Grade 1 |
|
| Grade 0 - Grade 2 |
|
| Grade 0 - Grade 3 |
|
| Grade 1 - Grade 0 |
|
| Grade 1 - Grade 1 |
|
| Grade 1 - Grade 2 |
|
| Grade 1 - Grade 3 |
|
| Grade 2 - Grade 0 |
|
| Grade 2 - Grade 1 |
|
| Grade 2 - Grade 2 |
|
| Grade 2 - Grade 3 |
|
| Grade 3 - Grade 0 |
|
| Grade 3 - Grade 1 |
|
| Grade 3 - Grade 2 |
|
| Grade 3 - Grade 3 |
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| Grade 4 - Grade 0 |
|
| Grade 4 - Grade 1 |
|
| Grade 4 - Grade 2 |
|
| Grade 4 - Grade 3 |
|
| Grade 4 - Grade 4 |
|
| Grade 0 - Grade 4 |
|
| Grade 1 - Grade 4 |
|
| Grade 2 - Grade 4 |
|
| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
|
| Normal - Grade 0 |
|
| Normal - Grade 1 |
|
| Normal - Grade 2 |
|
| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
|
| High - Grade 3 |
|
| Grade 0 - Grade 1 |
|
| Grade 0 - Grade 2 |
|
| Grade 0 - Grade 3 |
|
| Grade 1 - Grade 0 |
|
| Grade 1 - Grade 1 |
|
| Grade 1 - Grade 2 |
|
| Grade 1 - Grade 3 |
|
| Grade 2 - Grade 0 |
|
| Grade 2 - Grade 1 |
|
| Grade 2 - Grade 2 |
|
| Grade 2 - Grade 3 |
|
| Grade 3 - Grade 0 |
|
| Grade 3 - Grade 1 |
|
| Grade 3 - Grade 2 |
|
| Grade 3 - Grade 3 |
|
| Grade 4 - Grade 0 |
|
| Grade 4 - Grade 1 |
|
| Grade 4 - Grade 2 |
|
| Grade 4 - Grade 3 |
|
| Grade 4 - Grade 4 |
|
| Grade 0 - Grade 4 |
|
| Grade 1 - Grade 4 |
|
| Grade 2 - Grade 4 |
|
| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
|
| Normal - Grade 0 |
|
| Normal - Grade 1 |
|
| Normal - Grade 2 |
|
| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
|
| High - Grade 3 |
|
| Grade 0 - Grade 1 |
|
| Grade 0 - Grade 2 |
|
| Grade 0 - Grade 3 |
|
| Grade 1 - Grade 0 |
|
| Grade 1 - Grade 1 |
|
| Grade 1 - Grade 2 |
|
| Grade 1 - Grade 3 |
|
| Grade 2 - Grade 0 |
|
| Grade 2 - Grade 1 |
|
| Grade 2 - Grade 2 |
|
| Grade 2 - Grade 3 |
|
| Grade 3 - Grade 0 |
|
| Grade 3 - Grade 1 |
|
| Grade 3 - Grade 2 |
|
| Grade 3 - Grade 3 |
|
| Grade 4 - Grade 0 |
|
| Grade 4 - Grade 1 |
|
| Grade 4 - Grade 2 |
|
| Grade 4 - Grade 3 |
|
| Grade 4 - Grade 4 |
|
| Grade 0 - Grade 4 |
|
| Grade 1 - Grade 4 |
|
| Grade 2 - Grade 4 |
|
| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
|
| Normal - Grade 0 |
|
| Normal - Grade 1 |
|
| Normal - Grade 2 |
|
| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
|
| High - Grade 3 |
|
| Grade 0 - Grade 1 |
|
| Grade 0 - Grade 2 |
|
| Grade 0 - Grade 3 |
|
| Grade 1 - Grade 0 |
|
| Grade 1 - Grade 1 |
|
| Grade 1 - Grade 2 |
|
| Grade 1 - Grade 3 |
|
| Grade 2 - Grade 0 |
|
| Grade 2 - Grade 1 |
|
| Grade 2 - Grade 2 |
|
| Grade 2 - Grade 3 |
|
| Grade 3 - Grade 0 |
|
| Grade 3 - Grade 1 |
|
| Grade 3 - Grade 2 |
|
| Grade 3 - Grade 3 |
|
| Grade 4 - Grade 0 |
|
| Grade 4 - Grade 1 |
|
| Grade 4 - Grade 2 |
|
| Grade 4 - Grade 3 |
|
| Grade 4 - Grade 4 |
|
| Grade 0 - Grade 4 |
|
| Grade 1 - Grade 4 |
|
| Grade 2 - Grade 4 |
|
| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
|
| Normal - Grade 0 |
|
| Normal - Grade 1 |
|
| Normal - Grade 2 |
|
| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
|
| High - Grade 3 |
|
| Grade 0 - Grade 1 |
|
| Grade 0 - Grade 2 |
|
| Grade 0 - Grade 3 |
|
| Grade 1 - Grade 0 |
|
| Grade 1 - Grade 1 |
|
| Grade 1 - Grade 2 |
|
| Grade 1 - Grade 3 |
|
| Grade 2 - Grade 0 |
|
| Grade 2 - Grade 1 |
|
| Grade 2 - Grade 2 |
|
| Grade 2 - Grade 3 |
|
| Grade 3 - Grade 0 |
|
| Grade 3 - Grade 1 |
|
| Grade 3 - Grade 2 |
|
| Grade 3 - Grade 3 |
|
| Grade 4 - Grade 0 |
|
| Grade 4 - Grade 1 |
|
| Grade 4 - Grade 2 |
|
| Grade 4 - Grade 3 |
|
| Grade 4 - Grade 4 |
|
| Grade 0 - Grade 4 |
|
| Grade 1 - Grade 4 |
|
| Grade 2 - Grade 4 |
|
| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
|
| Normal - Grade 0 |
|
| Normal - Grade 1 |
|
| Normal - Grade 2 |
|
| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
|
| High - Grade 3 |
|
| Grade 0 - Grade 1 |
|
| Grade 0 - Grade 2 |
|
| Grade 0 - Grade 3 |
|
| Grade 1 - Grade 0 |
|
| Grade 1 - Grade 1 |
|
| Grade 1 - Grade 2 |
|
| Grade 1 - Grade 3 |
|
| Grade 2 - Grade 0 |
|
| Grade 2 - Grade 1 |
|
| Grade 2 - Grade 2 |
|
| Grade 2 - Grade 3 |
|
| Grade 3 - Grade 0 |
|
| Grade 3 - Grade 1 |
|
| Grade 3 - Grade 2 |
|
| Grade 3 - Grade 3 |
|
| Grade 4 - Grade 0 |
|
| Grade 4 - Grade 1 |
|
| Grade 4 - Grade 2 |
|
| Grade 4 - Grade 3 |
|
| Grade 4 - Grade 4 |
|
| Grade 0 - Grade 4 |
|
| Grade 1 - Grade 4 |
|
| Grade 2 - Grade 4 |
|
| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
|
| Normal - Grade 0 |
|
| Normal - Grade 1 |
|
| Normal - Grade 2 |
|
| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
|
| High - Grade 3 |
|
| Grade 0 - Grade 1 |
|
| Grade 0 - Grade 2 |
|
| Grade 0 - Grade 3 |
|
| Grade 1 - Grade 0 |
|
| Grade 1 - Grade 1 |
|
| Grade 1 - Grade 2 |
|
| Grade 1 - Grade 3 |
|
| Grade 2 - Grade 0 |
|
| Grade 2 - Grade 1 |
|
| Grade 2 - Grade 2 |
|
| Grade 2 - Grade 3 |
|
| Grade 3 - Grade 0 |
|
| Grade 3 - Grade 1 |
|
| Grade 3 - Grade 2 |
|
| Grade 3 - Grade 3 |
|
| Grade 4 - Grade 0 |
|
| Grade 4 - Grade 1 |
|
| Grade 4 - Grade 2 |
|
| Grade 4 - Grade 3 |
|
| Grade 4 - Grade 4 |
|
| Grade 0 - Grade 4 |
|
| Grade 1 - Grade 4 |
|
| Grade 2 - Grade 4 |
|
| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
|
| Normal - Grade 0 |
|
| Normal - Grade 1 |
|
| Normal - Grade 2 |
|
| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
|
| High - Grade 3 |
|
| Grade 0 - Grade 1 |
|
| Grade 0 - Grade 2 |
|
| Grade 0 - Grade 3 |
|
| Grade 1 - Grade 0 |
|
| Grade 1 - Grade 1 |
|
| Grade 1 - Grade 2 |
|
| Grade 1 - Grade 3 |
|
| Grade 2 - Grade 0 |
|
| Grade 2 - Grade 1 |
|
| Grade 2 - Grade 2 |
|
| Grade 2 - Grade 3 |
|
| Grade 3 - Grade 0 |
|
| Grade 3 - Grade 1 |
|
| Grade 3 - Grade 2 |
|
| Grade 3 - Grade 3 |
|
| Grade 4 - Grade 0 |
|
| Grade 4 - Grade 1 |
|
| Grade 4 - Grade 2 |
|
| Grade 4 - Grade 3 |
|
| Grade 4 - Grade 4 |
|
| Grade 0 - Grade 4 |
|
| Grade 1 - Grade 4 |
|
| Grade 2 - Grade 4 |
|
| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
|
| Normal - Grade 0 |
|
| Normal - Grade 1 |
|
| Normal - Grade 2 |
|
| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
|
| High - Grade 3 |
|
| Grade 0 - Grade 1 |
|
| Grade 0 - Grade 2 |
|
| Grade 0 - Grade 3 |
|
| Grade 1 - Grade 0 |
|
| Grade 1 - Grade 1 |
|
| Grade 1 - Grade 2 |
|
| Grade 1 - Grade 3 |
|
| Grade 2 - Grade 0 |
|
| Grade 2 - Grade 1 |
|
| Grade 2 - Grade 2 |
|
| Grade 2 - Grade 3 |
|
| Grade 3 - Grade 0 |
|
| Grade 3 - Grade 1 |
|
| Grade 3 - Grade 2 |
|
| Grade 3 - Grade 3 |
|
| Grade 4 - Grade 0 |
|
| Grade 4 - Grade 1 |
|
| Grade 4 - Grade 2 |
|
| Grade 4 - Grade 3 |
|
| Grade 4 - Grade 4 |
|
| Grade 0 - Grade 4 |
|
| Grade 1 - Grade 4 |
|
| Grade 2 - Grade 4 |
|
| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
|
| Normal - Grade 0 |
|
| Normal - Grade 1 |
|
| Normal - Grade 2 |
|
| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
|
| High - Grade 3 |
|
| Grade 0 - Grade 1 |
|
| Grade 0 - Grade 2 |
|
| Grade 0 - Grade 3 |
|
| Grade 1 - Grade 0 |
|
| Grade 1 - Grade 1 |
|
| Grade 1 - Grade 2 |
|
| Grade 1 - Grade 3 |
|
| Grade 2 - Grade 0 |
|
| Grade 2 - Grade 1 |
|
| Grade 2 - Grade 2 |
|
| Grade 2 - Grade 3 |
|
| Grade 3 - Grade 0 |
|
| Grade 3 - Grade 1 |
|
| Grade 3 - Grade 2 |
|
| Grade 3 - Grade 3 |
|
| Grade 4 - Grade 0 |
|
| Grade 4 - Grade 1 |
|
| Grade 4 - Grade 2 |
|
| Grade 4 - Grade 3 |
|
| Grade 4 - Grade 4 |
|
| Grade 0 - Grade 4 |
|
| Grade 1 - Grade 4 |
|
| Grade 2 - Grade 4 |
|
| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
|
| Normal - Grade 0 |
|
| Normal - Grade 1 |
|
| Normal - Grade 2 |
|
| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
|
| High - Grade 3 |
|
| Grade 0 - Grade 1 |
|
| Grade 0 - Grade 2 |
|
| Grade 0 - Grade 3 |
|
| Grade 1 - Grade 0 |
|
| Grade 1 - Grade 1 |
|
| Grade 1 - Grade 2 |
|
| Grade 1 - Grade 3 |
|
| Grade 2 - Grade 0 |
|
| Grade 2 - Grade 1 |
|
| Grade 2 - Grade 2 |
|
| Grade 2 - Grade 3 |
|
| Grade 3 - Grade 0 |
|
| Grade 3 - Grade 1 |
|
| Grade 3 - Grade 2 |
|
| Grade 3 - Grade 3 |
|
| Grade 4 - Grade 0 |
|
| Grade 4 - Grade 1 |
|
| Grade 4 - Grade 2 |
|
| Grade 4 - Grade 3 |
|
| Grade 4 - Grade 4 |
|
| Grade 0 - Grade 4 |
|
| Grade 1 - Grade 4 |
|
| Grade 2 - Grade 4 |
|
| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
|
| Normal - Grade 0 |
|
| Normal - Grade 1 |
|
| Normal - Grade 2 |
|
| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
|
| High - Grade 3 |
|
| Grade 0 - Grade 1 |
|
| Grade 0 - Grade 2 |
|
| Grade 0 - Grade 3 |
|
| Grade 1 - Grade 0 |
|
| Grade 1 - Grade 1 |
|
| Grade 1 - Grade 2 |
|
| Grade 1 - Grade 3 |
|
| Grade 2 - Grade 0 |
|
| Grade 2 - Grade 1 |
|
| Grade 2 - Grade 2 |
|
| Grade 2 - Grade 3 |
|
| Grade 3 - Grade 0 |
|
| Grade 3 - Grade 1 |
|
| Grade 3 - Grade 2 |
|
| Grade 3 - Grade 3 |
|
| Grade 4 - Grade 0 |
|
| Grade 4 - Grade 1 |
|
| Grade 4 - Grade 2 |
|
| Grade 4 - Grade 3 |
|
| Grade 4 - Grade 4 |
|
| Grade 0 - Grade 4 |
|
| Grade 1 - Grade 4 |
|
| Grade 2 - Grade 4 |
|
| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
|
| Normal - Grade 0 |
|
| Normal - Grade 1 |
|
| Normal - Grade 2 |
|
| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
|
| High - Grade 3 |
|
| Grade 0 - Grade 1 |
|
| Grade 0 - Grade 2 |
|
| Grade 0 - Grade 3 |
|
| Grade 1 - Grade 0 |
|
| Grade 1 - Grade 1 |
|
| Grade 1 - Grade 2 |
|
| Grade 1 - Grade 3 |
|
| Grade 2 - Grade 0 |
|
| Grade 2 - Grade 1 |
|
| Grade 2 - Grade 2 |
|
| Grade 2 - Grade 3 |
|
| Grade 3 - Grade 0 |
|
| Grade 3 - Grade 1 |
|
| Grade 3 - Grade 2 |
|
| Grade 3 - Grade 3 |
|
| Grade 4 - Grade 0 |
|
| Grade 4 - Grade 1 |
|
| Grade 4 - Grade 2 |
|
| Grade 4 - Grade 3 |
|
| Grade 4 - Grade 4 |
|
| Grade 0 - Grade 4 |
|
| Grade 1 - Grade 4 |
|
| Grade 2 - Grade 4 |
|
| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
|
| Normal - Grade 0 |
|
| Normal - Grade 1 |
|
| Normal - Grade 2 |
|
| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
|
| High - Grade 3 |
|
| Grade 0 - Grade 1 |
|
| Grade 0 - Grade 2 |
|
| Grade 0 - Grade 3 |
|
| Grade 1 - Grade 0 |
|
| Grade 1 - Grade 1 |
|
| Grade 1 - Grade 2 |
|
| Grade 1 - Grade 3 |
|
| Grade 2 - Grade 0 |
|
| Grade 2 - Grade 1 |
|
| Grade 2 - Grade 2 |
|
| Grade 2 - Grade 3 |
|
| Grade 3 - Grade 0 |
|
| Grade 3 - Grade 1 |
|
| Grade 3 - Grade 2 |
|
| Grade 3 - Grade 3 |
|
| Grade 4 - Grade 0 |
|
| Grade 4 - Grade 1 |
|
| Grade 4 - Grade 2 |
|
| Grade 4 - Grade 3 |
|
| Grade 4 - Grade 4 |
|
| Grade 0 - Grade 4 |
|
| Grade 1 - Grade 4 |
|
| Grade 2 - Grade 4 |
|
| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
|
| Normal - Grade 0 |
|
| Normal - Grade 1 |
|
| Normal - Grade 2 |
|
| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
|
| High - Grade 3 |
|
| Grade 0 - Grade 1 |
|
| Grade 0 - Grade 2 |
|
| Grade 0 - Grade 3 |
|
| Grade 1 - Grade 0 |
|
| Grade 1 - Grade 1 |
|
| Grade 1 - Grade 2 |
|
| Grade 1 - Grade 3 |
|
| Grade 2 - Grade 0 |
|
| Grade 2 - Grade 1 |
|
| Grade 2 - Grade 2 |
|
| Grade 2 - Grade 3 |
|
| Grade 3 - Grade 0 |
|
| Grade 3 - Grade 1 |
|
| Grade 3 - Grade 2 |
|
| Grade 3 - Grade 3 |
|
| Grade 4 - Grade 0 |
|
| Grade 4 - Grade 1 |
|
| Grade 4 - Grade 2 |
|
| Grade 4 - Grade 3 |
|
| Grade 4 - Grade 4 |
|
| Grade 0 - Grade 4 |
|
| Grade 1 - Grade 4 |
|
| Grade 2 - Grade 4 |
|
| Grade 3 - Grade 4 |
|
| Missing |
|
| Low - Grade 0 |
|
| Normal - Grade 0 |
|
| Normal - Grade 1 |
|
| Normal - Grade 2 |
|
| Normal - Grade 3 |
|
| High - Grade 0 |
|
| High - Grade 1 |
|
| High - Grade 2 |
|
| High - Grade 3 |
|
| Positive |
|
| Unknown |
|