Sample 103

Evaluation Instructions

Important: Models were tasked with extracting evidence from documents. Some outputs may be low quality and should be scored accordingly.

Your task: Compare the model-generated prediction (right panel) against the ground truth criteria (left panel).

Clean view: Shows formatted, readable text for easy comparison
Diff view: Highlights differences between ground truth and prediction
Raw view: Shows original unformatted text as it appears in the dataset

Evaluation scale (0-4):

0 = No match: Prediction is unrelated or contradicts the target criteria
1 = Poor match: Minimal overlap with ground truth, major errors or omissions
2 = Partial match: Some key elements captured, but notable gaps or inaccuracies
3 = Good match: Most elements correct, minor differences or formatting issues
4 = Excellent match: Essentially identical content, fully correct capture

Consider both content accuracy and completeness. Some predictions may be technically "correct" but incomplete or out of order.

Ground Truth

INCLUSION CRITERIA

  1. Male or female participants with ADPKD who completed study PA-ADPKD-303Continued control of hypertension without the use of a diureticContinued adherence to prohibitions on concomitant medications stated in the study PA-ADPKD-303 protocolWilling to practice acceptable methods of birth control (both males who have partners of child-bearing potential and females of childbearing potential).
  2. Able to provide informed consent.

EXCLUSION CRITERIA

  1. Any contraindication to continued treatment with lixivaptan
  2. Clinically significant incontinence, overactive bladder, or urinary retention (e.g., benign prostatic hyperplasia)
  3. New York Heart Association Functional Class 3 or 4 heart failure or other significant cardiac or electrocardiogram (ECG) findings that could pose a safety risk to the participant
  4. Hypovolemia on physical examination at Screening
  5. The following laboratory results based on serum drawn at Visit 24 of PA-ADPKD-303:Serum ALT or aspartate aminotransferase (AST) values >1.5 × ULNTotal bilirubin values >1.5 × ULNeGFR <20 mL/min/1.73 m^2 based on laboratory results from Visit 26 of PA-ADPKD-303A finding at Screening that precludes safe participation in the study or participants who are likely to be non-compliant with study procedures in the opinion of the Investigator or medical monitor

Prediction

Amended Eligibility Criteria (Version 7):

INCLUSION CRITERIA

1. Male or female participants with ADPKD who completed study PA-ADPKD-303.
2. Female participants must:
3. a. Not be pregnant, lactating, or breastfeeding.
4. b. Be either postmenopausal (defined as amenorrhea for ≥12 months), surgically sterile (defined as having undergone hysterectomy and/or bilateral oophorectomy), or if of child-bearing potential (WOCBP) must agree to continue to practice appropriate methods of birth control or remain abstinent (only if this is the usual and preferred lifestyle of the participant).
5. Male participants must agree to continue to use an acceptable form of birth control (see list above) or remain abstinent (only if this is the usual and preferred lifestyle of the participant) during the full duration of the trial and for 30 days after the last dose of lixivaptan treatment.
6. Continued control of hypertension without the use of a diuretic in concert with KDIGO “Clinical Practice Guideline for the Management of Blood Pressure in Chronic Kidney Disease.”
7. Continued adherence to prohibitions on concomitant medications stated in the study PA-ADPKD-303 protocol and in Section 5.7.1.2 of this protocol, including use of strong or moderate CYP3A4 or CYP2C8 inhibitors or inducers.
8. Read, understood, and provided written informed consent after the nature of the study has been fully explained and must be willing to comply with all study requirements and procedures.

EXCLUSION CRITERIA

1. Any contraindication to continued treatment with lixivaptan.
2. Clinically significant (CS) incontinence, overactive bladder, or urinary retention (e.g., benign prostatic hyperplasia).
3. New York Heart Association Functional Class 3 or 4 heart failure or other significant cardiac or electrocardiogram (ECG) findings that could pose a safety risk to the participant.
4. Hypovolemia on physical examination at Screening.
5. The following laboratory results based on serum drawn at Visit 24 of PA-ADPKD-303:
6. a. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values >1.5 × upper limit of normal (ULN).
7. b. Total bilirubin values >1.5 × ULN.
8. eGFR <20 ml/min/1.73 m² based on laboratory results from Visit 26 of PA-ADPKD-303.
9. A finding at Screening that precludes safe participation in the study or participants who are likely to be non-compliant with study procedures in the opinion of the Investigator or medical monitor.
10. These amendments incorporate the evidence provided, particularly focusing on the safety and tolerability of lixivaptan, while maintaining the clinical accuracy and relevance of the original criteria.