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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004390-41 | EudraCT Number | ||
| BLU-667-1101 | Registry Identifier | CT.Gov |
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This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of pralsetinib (BLU-667) administered orally in participants with medullary thyroid cancer (MTC), RET-altered NSCLC and other RET-altered solid tumors.
The study consists of 2 parts, a dose-escalation part (Phase 1) and an expansion part (Phase 2). Both parts will enroll participants with advanced non-resectable NSCLC, advanced non-resectable thyroid cancer and other advanced solid tumors that have progressed following standard systemic therapy, have not adequately responded to standard systemic therapy, or the participants must be intolerant to or the Investigator has determined that treatment with standard therapy is not appropriate, or there must be no accepted standard therapy for their disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Dose Escalation | Experimental | Multiple doses of pralsetinib (BLU-667) for oral administration. |
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| Phase 2 Dose Expansion | Experimental | Oral dose of pralsetinib (BLU-667) as determined during Dose Escalation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pralsetinib (BLU-667) | Drug | pralsetinib (BLU-667) is a potent and selective inhibitor of the RET mutations, fusions, and predicted resistant mutants |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 : Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Pralsetinib | MTD was defined as the highest tolerated dose of pralsetinib without causing dose limiting toxicities (DLTs). DLT was defined as any Grade ≥3 adverse event (AE) occurring during Cycle 1 during Phase 1 (dose escalation) that is not clearly caused by something other than pralsetinib. RP2D was defined as the highest dose with acceptable toxicity as determined from dose-escalation phase. | Up to approximately 30.8 months |
| Phase 1 and Phase 2: Number of Participants With AEs and Serious AEs (SAEs) | An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. | From Cycle 1 Day 1 up to 30 days after the final dose of study drug (up to approximately 6.7 years) |
| Phase 2: Overall Response Rate (ORR) | ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) for at least two assessments with at least 28 days apart and no disease progression (PD) in between. Per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in the short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). ORR and its two-sided 95% CI, based on the exact binomial distribution (Clopper-Pearson), were presented. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: ORR | ORR was defined as the percentage of participants with a confirmed CR or PR for at least two assessments with at least 28 days apart and no PD in between. Per RECIST v1.1, CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in the short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). ORR and its two-sided 95% CI, based on the exact binomial distribution (Clopper-Pearson), was presented. |
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Key Inclusion Criteria:
Diagnosis during dose escalation (Phase 1) - Pathologically documented, definitively diagnosed non-resectable advanced solid tumor.
Diagnosis during dose expansion (Phase 2) - All participants (with the exception of participants with MTC enrolled in Groups 3, 4, and 9) must have an oncogenic RET-rearrangement/fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor, as determined by local or central testing of tumor or circulating tumor nucleic acid in blood; as detailed below.
Participants must have non-resectable disease.
Dose expansion (Phase 2): Participants in all groups (except Group 7) must have measurable disease per RECIST v1.1 (or RANO, criteria if appropriate for tumor type).
Participants agrees to provide tumor tissue (archived, if available or a fresh biopsy) for RET status confirmation and is willing to consider an on-treatment tumor biopsy, if considered safe and medically feasible by the treating Investigator. For Phase 2, Group 6, participants are required to undergo a pretreatment biopsy to define baseline RET status in tumor tissue.
Participants has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
Key Exclusion Criteria:
Participant's cancer has a known primary driver alteration other than RET. For example, NSCLC with a targetable mutation in EGFR, ALK, ROS1 or BRAF; colorectal with an oncogenic KRAS, NRAS, or BRAF mutation.
Participants had any of the following within 14 days prior to the first dose of study drug:
QT interval corrected using Fridericia's formula (QTcF) > 470 msec or history of prolonged QT syndrome or Torsades de pointes, or familial history of prolonged QT syndrome.
Clinically significant, uncontrolled, cardiovascular disease.
Central nervous system (CNS) metastases or a primary CNS tumor that is associated with progressive neurological symptoms.
Clinically symptomatic interstitial lung disease or interstitial pneumonitis including radiation pneumonitis
Participants in Groups 1-5 and 7 (Phase 2) previously treated with a selective RET inhibitor
Participant had a major surgical procedure within 14 days of the first dose of study drug
Participant had a history of another primary malignancy that had been diagnosed or required therapy within the a year prior to the study
Pregnant or breastfeeding female participants
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | United States | ||
| UC Irvine Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41886723 | Derived | Besse B, Subbiah V, Curigliano G, Bowles DW, Doebele RC, Mansfield AS, Baik CS, de Lima Lopes G, Paz-Ares L, Taylor MH, Tan DSW, Alonso G, Gadgeel SM, Kalemkerian GP, Ou SI, van der Wekken AJ, Becerra CR, Evangelist M, Griesinger F, Liu SV, Lou Y, Mazieres J, Melear JM, Narang M, Saxena A, Thomas M, Wang S, Thomassen A, Lee DH, Kim DW, Gainor JF. Final Efficacy and Safety Data From the Phase I/II ARROW Study of Pralsetinib in Patients With Advanced RET Fusion-Positive Non-Small Cell Lung Cancer. J Clin Oncol. 2026 May;44(13):1190-1197. doi: 10.1200/JCO-25-01489. Epub 2026 Mar 26. | |
| 40639400 |
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For Phase I, The number of participants in each arm within the participant flow reflects the arms they were originally assigned to, whereas numbers reported in the pharmacokinetics outcome measure (OM) represent the number based on actual treatment received by the participants. 1 participant assigned to the 200/100 mg arm received the 100/100 mg treatment. Hence, was counted under the 100/100 mg arm in the PK-evaluable population.
A total of 590 participants with rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), RET mutation-positive medullary thyroid cancer (also known as RET-mutant MTC), RET fusion-positive thyroid cancer (TC) and other advanced solid tumors took part in the study at 74 investigative sites across 13 countries from 17 March 2017 to 21 March 2024. The study was divided into two parts: Phase 1 (Dose Escalation) and Phase 2 (Dose Expansion).
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I: Pralsetinib 30 mg | Participants received pralsetinib 30 milligrams (mg), orally, once a day (QD) until discontinuation due to toxicity, disease progression, or other reasons. |
| FG001 | Phase I: Pralsetinib 60 mg |
| 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 | Dec 1, 2022 | Mar 19, 2025 |
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Phase 1 (Complete):
Phase 2 (400mg QD):
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| Up to approximately 79.8 months |
| Up to approximately 28 months |
| Phase 1 and Phase 2: ORR in RET-fusion Positive NSCLC Participants With Specific RET Gene Status | Oncogenic RET rearrangements have been identified in 1%-2% of NSCLC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., Kinesin family member 5B (KIF5B), coiled-coil domain containing 6 (CCDC6), nuclear receptor coactivator 4 (NCOA4)). RET genotypes were determined by local testing and/or central analysis of circulating tumor deoxyribonucleic acid (ctDNA). ORR was assessed in participants having specific RET rearrangements. ORR was defined as the percentage of participants with a confirmed CR or PR for at least 2 assessments with at least 28 days apart and no PD in between. CR, PR, and PD were defined per RECIST as outlined in the description for OM 3. | Up to approximately 79.8 months |
| Phase 1 and Phase 2: ORR in RET-mutation MTC Participants With Specific RET Gene Status | Oncogenic RET activation has been implicated as a driver in MTC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., M918T, cysteine rich domain, V804X). RET genotypes were determined by local testing and/or central analysis of ctDNA. ORR was assessed in participants having specific RET rearrangements. ORR was defined as the percentage of participants with a confirmed CR or PR for at least 2 assessments with at least 28 days apart and no PD in between. CR, PR, and PD were defined per RECIST as outlined in the description for OM 3. | Up to approximately 79.8 months |
| Phase 1 and Phase 2: ORR in RET-fusion Positive TC Participants With Specific RET Gene Status | Oncogenic RET activation has been implicated as a driver in both MTC and differentiated TC (DTC). These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., KIF5B, CCDC6, NCOA4). RET genotypes were determined by local testing and/or central analysis of ctDNA. ORR was assessed in participants having specific RET rearrangements. ORR was defined as the percentage of participants with a confirmed CR or PR for at least 2 assessments with at least 28 days apart and no PD in between. CR, PR, and PD were defined per RECIST as outlined in the description for OM 3. | Up to approximately 79.8 months |
| Phase 1 and Phase 2: Clinical Benefit Rate (CBR) in RET-fusion Positive NSCLC Participants With Specific RET Gene Status | Oncogenic RET rearrangements have been identified in 1%-2% of NSCLC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., KIF5B, CCDC6, NCOA4). RET genotypes were determined by local testing and/or central analysis of ctDNA. CBR was assessed in participants having specific RET rearrangements. CBR was defined as the percentage of participants with a confirmed CR or PR, or stable disease (SD) which has been lasting at least 16 weeks (i.e. 4 cycles if 28 days are in one cycle) from the first dose date. CR and PR were defined per RECIST as outlined in the description for OM 3. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). | Up to approximately 79.8 months |
| Phase 1 and Phase 2: CBR in RET-mutation MTC Participants With Specific RET Gene Status | Oncogenic RET activation has been implicated as a driver in MTC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., M918T, cysteine rich domain, V804X). RET genotypes were determined by local testing and/or central analysis of ctDNA. CBR was assessed in participants having specific RET rearrangements. CBR was defined as the percentage of participants with a confirmed CR or PR, or SD which has been lasting at least 16 weeks (i.e. 4 cycles if 28 days are in one cycle) from the first dose date. CR and PR were defined per RECIST as outlined in the description for OM 3. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). | Up to approximately 79.8 months |
| Phase 1 and Phase 2: CBR in RET-fusion Positive TC Participants With Specific RET Gene Status | Oncogenic RET activation has been implicated as a driver in both MTC and DTC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., KIF5B, CCDC6, NCOA4). RET genotypes were determined by local testing and/or central analysis of ctDNA. CBR was assessed in participants having specific RET rearrangements. CBR was defined as the percentage of participants with a confirmed CR or PR or SD which has been lasting at least 16 weeks (i.e. 4 cycles if 28 days are in one cycle) from the first dose date. CR and PR were defined per RECIST as outlined in the description for OM 3. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). | Up to approximately 79.8 months |
| Phase 1 and Phase 2: Disease Control Rate (DCR) in RET-fusion Positive NSCLC Participants With Specific RET Gene Status | Oncogenic RET rearrangements have been identified in 1%-2% of NSCLC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., KIF5B, CCDC6, NCOA4). RET genotypes were determined by local testing and/or central analysis of ctDNA. DCR was assessed in participants having specific RET rearrangements. DCR was defined as the percentage of participants with a confirmed CR/PR, or SD. CR and PR were defined per RECIST as outlined in the description for OM 3. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). | Up to approximately 79.8 months |
| Phase 1 and Phase 2: DCR in RET-mutation MTC Participants With Specific RET Gene Status | Oncogenic RET activation has been implicated as a driver in MTC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., M918T, cysteine rich domain, V804X). RET genotypes were determined by local testing and/or central analysis of ctDNA. DCR was assessed in participants having specific RET rearrangements. DCR was defined as the percentage of participants with a confirmed CR/PR, or SD. CR and PR were defined per RECIST as outlined in the description for OM 3. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). | Up to approximately 79.8 months |
| Phase 1 and Phase 2: DCR in RET-fusion Positive TC Participants With Specific RET Gene Status | Oncogenic RET activation has been implicated as a driver in both MTC and DTC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., KIF5B, CCDC6, NCOA4). RET genotypes were determined by local testing and/or central analysis of ctDNA. DCR was assessed in participants having specific RET rearrangements. DCR was defined as the percentage of participants with a confirmed CR/PR, or SD. CR and PR were defined per RECIST as outlined in the description for OM 3. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). | Up to approximately 79.8 months |
| Phase 1 and Phase 2: Duration of Response (DOR) in RET-mutation NSCLC Participants With Specific RET Gene Status | Oncogenic RET rearrangements have been identified in 1%-2% of NSCLC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., KIF5), CCDC6, NCOA4). RET genotypes were determined by local testing &/or central analysis of circulating tumor deoxyribonucleic acid (ctDNA). DOR was assessed in participants having specific RET rearrangements. DOR=time from first documented CR/PR to date of first documented PD or death due to any cause, whichever occurs first. Per RECIST, CR=disappearance of all target lesions or any pathological lymph nodes (target or non-target) having a reduction in the short axis to <10 mm. PR=at least a 30% decrease in SOD of all target lesions, taking as reference the baseline SOD, in absence of CR. PD=as at least a 20% increase in SOD of target lesions, taking as reference smallest SOD on study. DOR was analyzed using the Kaplan-Meier (KM) method. | Up to approximately 79.8 months |
| Phase 1 and Phase 2: DOR in RET-mutation MTC Participants With Specific RET Gene Status | Oncogenic RET activation has been implicated as a driver in MTC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., M918T, cysteine rich domain, V804X). RET genotypes were determined by local testing and/or central analysis of ctDNA. DOR was assessed in participants having specific RET rearrangements. DOR=time from first documented CR/PR to date of first documented PD or death due to any cause, whichever occurs first. Per RECIST, CR= disappearance of all target lesions or any pathological lymph nodes (target or non-target) having a reduction in the short axis to <10 mm. PR=at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in absence of CR. PD=as at least a 20% increase in SOD of target lesions, taking as reference smallest SOD on study (including baseline). DOR was analyzed using the Kaplan-Meier (KM) method. | Up to approximately 79.8 months |
| Phase 1 and Phase 2: DOR in RET-fusion Positive TC Participants With Specific RET Gene Status | Oncogenic RET activation has been implicated as a driver in MTC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., KIF5B, CCDC6, NCOA4). RET genotypes were determined by local testing and/or central analysis of ctDNA. DOR was assessed in participants having specific RET rearrangements. DOR=time from first documented CR/PR to date of first documented PD or death due to any cause, whichever occurs first. Per RECIST, CR= disappearance of all target lesions or any pathological lymph nodes (target or non-target) having a reduction in the short axis to <10 mm. PR=at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in absence of CR. PD=as at least a 20% increase in SOD of target lesions, taking as reference smallest SOD on study (including baseline). DOR was analyzed using the KM method. | Up to approximately 79.8 months |
| Phase 2: DOR | DOR was defined as the time from first documented response (CR/PR) to the date of first documented PD or death due to any cause, whichever occurs first. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in the short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). DOR was analyzed using the KM methods. | Up to approximately 79.8 months |
| Phase 2: CBR | CBR was defined as the percentage of participants with CR or PR, or SD which has been lasting at least 16 weeks (i.e. 4 cycles if 28 days are in one cycle) from the first dose date. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in the short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). CBR and its two-sided 95% CI, which is based on the exact binomial distribution (Clopper-Pearson), were presented. | Up to approximately 79.8 months |
| Phase 2: DCR | DCR was defined as the percentage of participants with a confirmed CR/PR, or SD, per RECIST v1.1. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in the short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). DCR and its two-sided 95% CI, which is based on the exact binomial distribution (Clopper-Pearson), were presented. | Up to approximately 79.8 months |
| Phase 2: Progression-free Survival (PFS) | PFS was defined as the time from the first dose of pralsetinib to the date of first documented PD or death due to any cause, whichever occurred first. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). PFS was analyzed using KM methods. | Up to approximately 7 years |
| Phase 2: Overall Survival (OS) | OS was defined as the time from the first dose of pralsetinib to the date of death due to any causes. | Up to approximately 7 years |
| Phase 2: Intracranial ORR in RET-fusion Positive NSCLC Central Nervous System (CNS) Metastases Participants | ORR=percentage of participants with CR or PR for at least 2 assessments with at least 28 days apart & no PD in between. CR=disappearance of all target CNS/brain lesion, including lesions in brain stem &/or cerebellum identified at baseline & disappearance of all non-target CNS/brain lesion at baseline & no identification of new CNS/brain lesion. PR =at least a 30% decrease in the SOD of any CNS/brain lesion, identified as RECIST 1.1 target lesions at baseline & if in the absence of unequivocal progression of any non-target CNS/brain lesion at baseline, or the identification of new CNS/brain lesion. PD=either at least 20% increase in the SOD of target CNS/brain lesion, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm or unequivocal progression of any CNS/brain lesion identified as RECIST 1.1 nontarget lesions at baseline, or the identification of new CNS/brain lesion. | Up to approximately 79.8 months |
| Phase 2: Intracranial CBR in RET-fusion Positive NSCLC CNS Metastases Participants | CBR=percentage of participants with CR/PR/SD which has been lasting at least 16 weeks (i.e. 4 cycles if 28 days are in 1 cycle) from first dose date. CR=disappearance of all target CNS/brain lesion, including lesions in brain stem &/ cerebellum identified at baseline&disappearance of all non-target CNS/brain lesion at baseline & no identification of new CNS/brain lesion. PR=at least a 30% decrease in SOD of any CNS/brain lesion, identified as target lesions at baseline & if in absence of unequivocal progression of any non-target CNS/brain lesion at baseline, or identification of new CNS/brain lesion. SD=neither sufficient shrinkage for PR nor sufficient increase for PD for target/non-target CNS/brain lesion, taking as reference smallest SOD while on study. PD=either at least 20% increase in SOD of target CNS/brain lesion, taking as reference smallest sum on study. Unequivocal progression of any CNS/brain lesion nontarget lesions at baseline, or identification of new CNS/brain lesion. | Up to approximately 79.8 months |
| Phase 2: Intracranial DCR in RET-fusion Positive NSCLC CNS Metastases Participants | DCR=percentage of participants with a confirmed CR/PR, or SD. CR=disappearance of all target CNS/brain lesion, including lesions in brain stem &/or cerebellum identified at baseline & disappearance of all non-target CNS/brain lesion at baseline & no identification of new CNS/brain lesion. PR =at least a 30% decrease in the SOD of any CNS/brain lesion, identified as RECIST 1.1 target lesions at baseline & if in the absence of unequivocal progression of any non-target CNS/brain lesion at baseline, or the identification of new CNS/brain lesion. SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target/non-target CNS/brain lesion, taking as reference the smallest SOD while on study. PD=either at least 20% increase in SOD of target CNS/brain lesion, taking as reference smallest sum on study. Unequivocal progression of any CNS/brain lesion nontarget lesions at baseline, or identification of new CNS/brain lesion. | Up to approximately 79.8 months |
| Phase 2: Intracranial DOR in RET-fusion Positive NSCLC CNS Metastases Participants | DOR=time from first documented CR/PR to the date of first documented PD/death due to any cause, whichever occurs first. CR=disappearance of all target CNS/brain lesion, including lesions in brain stem &/ cerebellum identified at baseline & disappearance of all non-target CNS/brain lesion at baseline & no identification of new CNS/brain lesion. PR=at least a 30% decrease in SOD of any CNS/brain lesion, identified as RECIST 1.1 target lesions at baseline & if in absence of unequivocal progression of any non-target CNS/brain lesion at baseline, or identification of new CNS/brain lesion. PD=either at least 20% increase in SOD of target CNS/brain lesion, taking as reference smallest sum on study. Unequivocal progression of any CNS/brain lesion nontarget lesions at baseline, or identification of new CNS/brain lesion. DOR was analyzed using the KM methods. | Up to approximately 79.8 months |
| Phase 1: Maximum Plasma Concentration (Cmax) | Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
| Phase 1: Time to Maximum Plasma Concentration (Tmax) | Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
| Phase 1: Time of Last Quantifiable Plasma Drug Concentration (Tlast) | The maximum values for Tlast slightly exceed 24 hours because the analysis used the actual time, i.e., the duration between dosing and actual sample collection, rather than the nominal sampling time of 24 hours specified in the protocol. The timeframe has been given as per nominal sampling timepoints pre-specified in the protocol. Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
| Phase 1: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Postdose (AUC0-24) | Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | 24 hours postdose on Day 1 of Cycle 1 (1 cycle = 28 days) |
| Phase 1: Plasma Drug Concentration at 24 Hours Postdose (C24hr) | Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
| Phase 1: Apparent Volume of Distribution (Vz/F) | Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
| Phase 1: Terminal Elimination Half-Life (t½) | The maximum values for t1/2 slightly exceed 24 hours because the analysis used the actual time, i.e., the duration between dosing and actual sample collection, rather than the nominal sampling time of 24 hours specified in the protocol. The timeframe has been given as per nominal sampling timepoints pre-specified in the protocol. Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
| Phase 1: Apparent Oral Clearance (CL/F) | Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
| Phase 1: Accumulation Ratio for Cmax (RCmax) | Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | 24 hours postdose on Day 15 of Cycle 1 (1 cycle = 28 days) |
| Phase 1: Accumulation Ratio for AUC (RAUC) | Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | 24 hours postdose on Day 15 of Cycle 1 (1 cycle = 28 days) |
| Phase 2: Cmax | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
| Phase 2: Tmax | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
| Phase 2: Tlast | The maximum values for Tlast slightly exceed 24 hours because the analysis used the actual time, i.e., the duration between dosing and actual sample collection, rather than the nominal sampling time of 24 hours specified in the protocol. The timeframe has been given as per nominal sampling timepoints pre-specified in the protocol. | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
| Phase 2: AUC0-24 | 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
| Phase 2: C24hr | 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
| Phase 2: t½ | The maximum values for t1/2 slightly exceed 24 hours because the analysis used the actual time, i.e., the duration between dosing and actual sample collection, rather than the nominal sampling time of 24 hours specified in the protocol. The timeframe has been given as per nominal sampling timepoints pre-specified in the protocol. | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
| Phase 2: CL/F | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
| Phase 1: Percent Change From Baseline in Dual Specificity Phosphatase 6 (DUSP6) | The dose dependent change in a mitogen-activated protein kinases (MAPK) pathway expression signature was analyzed for all available samples of MTC and NSCLC participants. Participants with archived sample (used as baseline) and on treatment Cycle 2 Day 1 (1 cycle = 28 days) tumor tissues with greater than 20% tumor cells are included in the analysis. The changes in tumor biomarker DUSP6 levels was explored. | Baseline, Week 4 |
| Phase 1: Percent Change From Baseline in Sprout Receptor Tyrosine Kinase Signaling Antagonist 4 (SPRY4) | The dose dependent change in a MAPK pathway expression signature was analyzed for all available samples of MTC and NSCLC participants. Participants with archived sample (used as baseline) and on treatment Cycle 2 Day 1 (1 cycle = 28 days) tumor tissues with greater than 20% tumor cells are included in the analysis. The changes in tumor biomarker SPRY4 levels was explored. | Baseline, Week 4 |
| Orange |
| California |
| 92868 |
| United States |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Mayo Clinic-Jacksonville | Jacksonville | Florida | 32224 | United States |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136-1002 | United States |
| Maryland Oncology Hematology, P.A. | Columbia | Maryland | 21044-3257 | United States |
| Massachusetts General Hospital. | Boston | Massachusetts | 02114-2696 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109-0934 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55902-3003 | United States |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110-1010 | United States |
| Albany Medical Center | Albany | New York | 12208-3412 | United States |
| Weill Cornell Medical College-New York Presbyterian Hospital | New York | New York | 10021 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Texas Oncology-Austin Midtown | Austin | Texas | 78705-1165 | United States |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4000 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Antwerp University Hospital | Edegem | 2650 | Belgium |
| Beijing Cancer Hospital | Beijing | 100036 | China |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| The affiliated Cancer Hospital, School of Medicine, UESTC | Chengdu | 610041 | China |
| West China Hospital, Sichuan University | Chengdu | 610041 | China |
| Chongqing Cancer Hospital | Chongqing | 400030 | China |
| Fujian Provincial Cancer Hospital | Fuzhou | 350014 | China |
| First Affiliated Hospital of Gannan Medical University | Ganzhou | 341000 | China |
| Sun Yet-sen University Cancer Center | Guangzhou | 510060 | China |
| Guangdong General Hospital | Guangzhou | 510080 | China |
| Zhejiang Cancer Hospital | Hangzhou | 310022 | China |
| Jinan Central Hospital | Jinan | 250013 | China |
| Gansu Cancer Hospital | Lanzhou | 730050 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200120 | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjing | 300060 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | 430023 | China |
| Henan Cancer Hospital | Zhengzhou | 450008 | China |
| Institut Bergonie | Bordeaux | 33000 | France |
| Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez | Lille | 59037 | France |
| Centre Léon Bérard | Lyon | 69008 | France |
| Centre Antoine Lacassagne | Nice | 6100 | France |
| Institut Curie | Paris | 75248 | France |
| CHU de Rennes - Hopital de Pontchaillo | Rennes | 35033 | France |
| Hôpital Larrey | Toulouse | 31059 | France |
| Gustave Roussy | Villejuif | 94800 | France |
| Helios Klinikum Emil von Behring GmbH | Berlin | 14165 | Germany |
| Universitätsklinikum Essen | Essen | 45122 | Germany |
| Thoraxklinik Heidelberg gGmbH | Heidelberg | 69126 | Germany |
| Klinikum der Universität München | München | 81377 | Germany |
| Pius-Hospital | Oldenburg | 26121 | Germany |
| The Chinese University of Hong Kong | Shatin | 123456 | Hong Kong |
| Ospedale Santa Maria Delle Croci | Ravenna | Emilia-Romagna | 48100 | Italy |
| Istituto Nazionale Tumori Regina Elena | Rome | Lazio | 00144 | Italy |
| IEO | Milan | Lombardy | 20141 | Italy |
| Asst Grande Ospedale Metropolitano Niguarda | Milan | Lombardy | 20162 | Italy |
| Antoni van Leeuwenhoek Ziekenhuis | Amsterdam | 1066 CX | Netherlands |
| Universitair Medisch Centrum Groningen | Groningen | 9713 GZ | Netherlands |
| National Cancer Centre | Singapore | 169610 | Singapore |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 120-752 | South Korea |
| Institut Catala d Oncologia Hospitalet | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Vall d?Hebron Institute of Oncology (VHIO), Barcelona | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Guys and St Thomas NHS Foundation Trust, Guys Hospital | London | SE1 9RT | United Kingdom |
| University College London Hospitals NHS Foundation Trust | London | W1T 7HA | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Derived |
| Haddad RI, Bischoff L, Applewhite M, Bernet V, Blomain E, Brito M, Busaidy NL, Campbell M, DeLozier O, Duh QY, Ehya H, Grady E, Guo T, Haymart M, Hunt JP, Kandeel F, Kotwal A, Lamonica DM, Lorch J, Mandel SJ, Markovina S, Mydlarz W, Nabell L, Raeburn CD, Rezaee R, Ridge JA, Ritter H, Roth MY, Salgado SA, Scheri RP, Shah JP, Sipos JA, Sippel R, Sturgeon C, Wirth LJ, Wong RJ, Worden F, Yeh MW, Darlow S, Cassara CJ, Sliker B. NCCN Guidelines(R) Insights: Thyroid Carcinoma, Version 1.2025. J Natl Compr Canc Netw. 2025 Jul;23(7):e250033. doi: 10.6004/jnccn.2025.0033. |
| 38009200 | Derived | Subbiah V, Hu MI, Mansfield AS, Taylor MH, Schuler M, Zhu VW, Hadoux J, Curigliano G, Wirth L, Gainor JF, Alonso G, Adkins D, Godbert Y, Ahn MJ, Cassier PA, Cho BC, Lin CC, Zalutskaya A, Barata T, Trask P, Scalori A, Bordogna W, Heinzmann S, Brose MS. Pralsetinib in Patients with Advanced/Metastatic Rearranged During Transfection (RET)-Altered Thyroid Cancer: Updated Efficacy and Safety Data from the ARROW Study. Thyroid. 2024 Jan;34(1):26-40. doi: 10.1089/thy.2023.0363. |
| 37934000 | Derived | Subbiah V, Burris HA 3rd, Kurzrock R. Revolutionizing cancer drug development: Harnessing the potential of basket trials. Cancer. 2024 Jan;130(2):186-200. doi: 10.1002/cncr.35085. Epub 2023 Nov 7. |
| 37916501 | Derived | Griesinger F, Curigliano G, Subbiah V, Baik CS, Tan DS, Lee DH, Misch D, Garralda E, Kim DW, van der Wekken AJ, Gainor JF, Paz-Ares L, Liu SV, Kalemkerian GP, Bowles DW, Mansfield AS, Lin JJ, Smoljanovic V, Rahman A, Zalutskaya A, Louie-Gao M, Boral AL, Mazieres J. Pralsetinib in patients with RET fusion-positive non-small-cell lung cancer: A plain language summary of the ARROW study. Future Oncol. 2024 Feb;20(6):297-306. doi: 10.2217/fon-2023-0155. Epub 2023 Nov 2. |
| 37282666 | Derived | Zhou Q, Zhao J, Chang J, Wang H, Fan Y, Wang K, Wu G, Nian W, Sun Y, Sun M, Wang X, Shi H, Zheng X, Yao S, Qin M, Shen Z, Yang J, Wu YL. Efficacy and safety of pralsetinib in patients with advanced RET fusion-positive non-small cell lung cancer. Cancer. 2023 Oct 15;129(20):3239-3251. doi: 10.1002/cncr.34897. Epub 2023 Jun 6. |
| 35962206 | Derived | Subbiah V, Cassier PA, Siena S, Garralda E, Paz-Ares L, Garrido P, Nadal E, Vuky J, Lopes G, Kalemkerian GP, Bowles DW, Seetharam M, Chang J, Zhang H, Green J, Zalutskaya A, Schuler M, Fan Y, Curigliano G. Pan-cancer efficacy of pralsetinib in patients with RET fusion-positive solid tumors from the phase 1/2 ARROW trial. Nat Med. 2022 Aug;28(8):1640-1645. doi: 10.1038/s41591-022-01931-y. Epub 2022 Aug 12. |
| 35715405 | Derived | Popat S, Liu SV, Scheuer N, Hsu GG, Lockhart A, Ramagopalan SV, Griesinger F, Subbiah V. Addressing challenges with real-world synthetic control arms to demonstrate the comparative effectiveness of Pralsetinib in non-small cell lung cancer. Nat Commun. 2022 Jun 17;13(1):3500. doi: 10.1038/s41467-022-30908-1. |
| 34118198 | Derived | Subbiah V, Hu MI, Wirth LJ, Schuler M, Mansfield AS, Curigliano G, Brose MS, Zhu VW, Leboulleux S, Bowles DW, Baik CS, Adkins D, Keam B, Matos I, Garralda E, Gainor JF, Lopes G, Lin CC, Godbert Y, Sarker D, Miller SG, Clifford C, Zhang H, Turner CD, Taylor MH. Pralsetinib for patients with advanced or metastatic RET-altered thyroid cancer (ARROW): a multi-cohort, open-label, registrational, phase 1/2 study. Lancet Diabetes Endocrinol. 2021 Aug;9(8):491-501. doi: 10.1016/S2213-8587(21)00120-0. Epub 2021 Jun 9. |
| 34118197 | Derived | Gainor JF, Curigliano G, Kim DW, Lee DH, Besse B, Baik CS, Doebele RC, Cassier PA, Lopes G, Tan DSW, Garralda E, Paz-Ares LG, Cho BC, Gadgeel SM, Thomas M, Liu SV, Taylor MH, Mansfield AS, Zhu VW, Clifford C, Zhang H, Palmer M, Green J, Turner CD, Subbiah V. Pralsetinib for RET fusion-positive non-small-cell lung cancer (ARROW): a multi-cohort, open-label, phase 1/2 study. Lancet Oncol. 2021 Jul;22(7):959-969. doi: 10.1016/S1470-2045(21)00247-3. Epub 2021 Jun 9. |
Participants received pralsetinib 60 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
| FG002 | Phase I: Pralsetinib 100 mg | Participants received pralsetinib 100 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| FG003 | Phase I: Pralsetinib 200 mg | Participants received pralsetinib 200 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| FG004 | Phase I: Pralsetinib 300 mg | Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| FG005 | Phase I: Pralsetinib 400 mg | Participants received pralsetinib 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| FG006 | Phase I: Pralsetinib 600 mg | Participants received pralsetinib 600 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| FG007 | Phase I: Pralsetinib 100/100 mg | Participants received pralsetinib 100 mg, orally, twice a day (BID) until discontinuation due to toxicity, disease progression, or other reasons. |
| FG008 | Phase I: Pralsetinib 200/100 mg | Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons. |
| FG009 | Phase II: Pralsetinib 400 mg | Participants with advanced NSCLC, advanced non-resectable TC and other advanced non-resectable solid tumors with various rearranged during transfection (RET)-alterations were enrolled in this arm to receive pralsetinib, 400 mg, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all participants who had received at least 1 dose of the study drug regardless of the starting dose levels.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase I: Pralsetinib 30 mg | Participants received pralsetinib 30 milligrams (mg) orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| BG001 | Phase I: Pralsetinib 60 mg | Participants received pralsetinib 60 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| BG002 | Phase I: Pralsetinib 100 mg | Participants received pralsetinib 100 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| BG003 | Phase I: Pralsetinib 200 mg | Participants received pralsetinib 200 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| BG004 | Phase I: Pralsetinib 300 mg | Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| BG005 | Phase I: Pralsetinib 400 mg | Participants received pralsetinib 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| BG006 | Phase I: Pralsetinib 600 mg | Participants received pralsetinib 600 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| BG007 | Phase I: Pralsetinib 100/100 mg | Participants received pralsetinib 100 mg, orally, twice a day (BID) until discontinuation due to toxicity, disease progression, or other reasons. |
| BG008 | Phase I: Pralsetinib 200/100 mg | Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons. |
| BG009 | Phase II: Pralsetinib 400 mg | Participants with advanced NSCLC, advanced non-resectable TC and other advanced non-resectable solid tumors with various rearranged during transfection (RET)-alterations were enrolled in this arm to receive pralsetinib, 400 mg, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| BG010 | 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Phase 1 : Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Pralsetinib | MTD was defined as the highest tolerated dose of pralsetinib without causing dose limiting toxicities (DLTs). DLT was defined as any Grade ≥3 adverse event (AE) occurring during Cycle 1 during Phase 1 (dose escalation) that is not clearly caused by something other than pralsetinib. RP2D was defined as the highest dose with acceptable toxicity as determined from dose-escalation phase. | Dose-determining population included all participants in the dose-escalation part who have received ≥75% (21 days) of the study drug and completed safety evaluations through Cycle 1 Day 28 or experienced a DLT. | Posted | Number | mg | Up to approximately 30.8 months |
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| Primary | Phase 1 and Phase 2: Number of Participants With AEs and Serious AEs (SAEs) | An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. | Safety Population included all participants who have received at least 1 dose of the study drug regardless of starting dose levels. As pre-specified in the SAP, safety data was to be analyzed and reported as per the pre-planned grouped dose level II (SAP section 3.6.5.2). Hence, per dose safety data is not presented for this study. | Posted | Number | percentage of participants | From Cycle 1 Day 1 up to 30 days after the final dose of study drug (up to approximately 6.7 years) |
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| Primary | Phase 2: Overall Response Rate (ORR) | ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) for at least two assessments with at least 28 days apart and no disease progression (PD) in between. Per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in the short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). ORR and its two-sided 95% CI, based on the exact binomial distribution (Clopper-Pearson), were presented. | RET-altered measurable disease population included participants in the efficacy population who had measurable (target) disease per RECIST v1.1 at baseline according to blinded central review (BICR) and sufficient evidence of a RET alteration. As prespecified in the SAP, Phase 1 participants treated at 400 mg QD are also included in Phase 2 efficacy analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 79.8 months |
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| Secondary | Phase 1: ORR | ORR was defined as the percentage of participants with a confirmed CR or PR for at least two assessments with at least 28 days apart and no PD in between. Per RECIST v1.1, CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in the short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). ORR and its two-sided 95% CI, based on the exact binomial distribution (Clopper-Pearson), was presented. | Efficacy population included all participants who have been exposed to at least one dose of the study drug on or prior to 11 July 2019. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 28 months |
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| Secondary | Phase 1 and Phase 2: ORR in RET-fusion Positive NSCLC Participants With Specific RET Gene Status | Oncogenic RET rearrangements have been identified in 1%-2% of NSCLC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., Kinesin family member 5B (KIF5B), coiled-coil domain containing 6 (CCDC6), nuclear receptor coactivator 4 (NCOA4)). RET genotypes were determined by local testing and/or central analysis of circulating tumor deoxyribonucleic acid (ctDNA). ORR was assessed in participants having specific RET rearrangements. ORR was defined as the percentage of participants with a confirmed CR or PR for at least 2 assessments with at least 28 days apart and no PD in between. CR, PR, and PD were defined per RECIST as outlined in the description for OM 3. | RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR and sufficient evidence of a RET alteration. As prespecified in the SAP, Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. Number analyzed is the number of participants with the specified mutation. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 79.8 months |
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| Secondary | Phase 1 and Phase 2: ORR in RET-mutation MTC Participants With Specific RET Gene Status | Oncogenic RET activation has been implicated as a driver in MTC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., M918T, cysteine rich domain, V804X). RET genotypes were determined by local testing and/or central analysis of ctDNA. ORR was assessed in participants having specific RET rearrangements. ORR was defined as the percentage of participants with a confirmed CR or PR for at least 2 assessments with at least 28 days apart and no PD in between. CR, PR, and PD were defined per RECIST as outlined in the description for OM 3. | RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR and sufficient evidence of a RET alteration. As prespecified in the SAP, Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. Number analyzed is the number of participants with the specified mutation. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 79.8 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Phase 1 and Phase 2: ORR in RET-fusion Positive TC Participants With Specific RET Gene Status | Oncogenic RET activation has been implicated as a driver in both MTC and differentiated TC (DTC). These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., KIF5B, CCDC6, NCOA4). RET genotypes were determined by local testing and/or central analysis of ctDNA. ORR was assessed in participants having specific RET rearrangements. ORR was defined as the percentage of participants with a confirmed CR or PR for at least 2 assessments with at least 28 days apart and no PD in between. CR, PR, and PD were defined per RECIST as outlined in the description for OM 3. | RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR and sufficient evidence of a RET alteration. As prespecified in the SAP, Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. Number analyzed is the number of participants with the specified mutation. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 79.8 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Phase 1 and Phase 2: Clinical Benefit Rate (CBR) in RET-fusion Positive NSCLC Participants With Specific RET Gene Status | Oncogenic RET rearrangements have been identified in 1%-2% of NSCLC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., KIF5B, CCDC6, NCOA4). RET genotypes were determined by local testing and/or central analysis of ctDNA. CBR was assessed in participants having specific RET rearrangements. CBR was defined as the percentage of participants with a confirmed CR or PR, or stable disease (SD) which has been lasting at least 16 weeks (i.e. 4 cycles if 28 days are in one cycle) from the first dose date. CR and PR were defined per RECIST as outlined in the description for OM 3. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). | RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR and sufficient evidence of a RET alteration. As prespecified in the SAP, Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. Number analyzed is the number of participants with the specified mutation. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 79.8 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Phase 1 and Phase 2: CBR in RET-mutation MTC Participants With Specific RET Gene Status | Oncogenic RET activation has been implicated as a driver in MTC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., M918T, cysteine rich domain, V804X). RET genotypes were determined by local testing and/or central analysis of ctDNA. CBR was assessed in participants having specific RET rearrangements. CBR was defined as the percentage of participants with a confirmed CR or PR, or SD which has been lasting at least 16 weeks (i.e. 4 cycles if 28 days are in one cycle) from the first dose date. CR and PR were defined per RECIST as outlined in the description for OM 3. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). | RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR and sufficient evidence of a RET alteration. As prespecified in the SAP, Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. Number analyzed is the number of participants with the specified mutation. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 79.8 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Phase 1 and Phase 2: CBR in RET-fusion Positive TC Participants With Specific RET Gene Status | Oncogenic RET activation has been implicated as a driver in both MTC and DTC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., KIF5B, CCDC6, NCOA4). RET genotypes were determined by local testing and/or central analysis of ctDNA. CBR was assessed in participants having specific RET rearrangements. CBR was defined as the percentage of participants with a confirmed CR or PR or SD which has been lasting at least 16 weeks (i.e. 4 cycles if 28 days are in one cycle) from the first dose date. CR and PR were defined per RECIST as outlined in the description for OM 3. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). | RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR and sufficient evidence of a RET alteration. As prespecified in the SAP, Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. Number analyzed is the number of participants with the specified mutation. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 79.8 months |
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| Secondary | Phase 1 and Phase 2: Disease Control Rate (DCR) in RET-fusion Positive NSCLC Participants With Specific RET Gene Status | Oncogenic RET rearrangements have been identified in 1%-2% of NSCLC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., KIF5B, CCDC6, NCOA4). RET genotypes were determined by local testing and/or central analysis of ctDNA. DCR was assessed in participants having specific RET rearrangements. DCR was defined as the percentage of participants with a confirmed CR/PR, or SD. CR and PR were defined per RECIST as outlined in the description for OM 3. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). | RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR and sufficient evidence of a RET alteration. As prespecified in the SAP, Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. Number analyzed is the number of participants with the specified mutation. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 79.8 months |
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| Secondary | Phase 1 and Phase 2: DCR in RET-mutation MTC Participants With Specific RET Gene Status | Oncogenic RET activation has been implicated as a driver in MTC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., M918T, cysteine rich domain, V804X). RET genotypes were determined by local testing and/or central analysis of ctDNA. DCR was assessed in participants having specific RET rearrangements. DCR was defined as the percentage of participants with a confirmed CR/PR, or SD. CR and PR were defined per RECIST as outlined in the description for OM 3. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). | RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR and sufficient evidence of a RET alteration. As prespecified in the SAP, Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. Number analyzed is the number of participants with the specified mutation. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 79.8 months |
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| Secondary | Phase 1 and Phase 2: DCR in RET-fusion Positive TC Participants With Specific RET Gene Status | Oncogenic RET activation has been implicated as a driver in both MTC and DTC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., KIF5B, CCDC6, NCOA4). RET genotypes were determined by local testing and/or central analysis of ctDNA. DCR was assessed in participants having specific RET rearrangements. DCR was defined as the percentage of participants with a confirmed CR/PR, or SD. CR and PR were defined per RECIST as outlined in the description for OM 3. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). | RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR and sufficient evidence of a RET alteration. As prespecified in the SAP, Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. Number analyzed is the number of participants with the specified mutation. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 79.8 months |
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| Secondary | Phase 1 and Phase 2: Duration of Response (DOR) in RET-mutation NSCLC Participants With Specific RET Gene Status | Oncogenic RET rearrangements have been identified in 1%-2% of NSCLC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., KIF5), CCDC6, NCOA4). RET genotypes were determined by local testing &/or central analysis of circulating tumor deoxyribonucleic acid (ctDNA). DOR was assessed in participants having specific RET rearrangements. DOR=time from first documented CR/PR to date of first documented PD or death due to any cause, whichever occurs first. Per RECIST, CR=disappearance of all target lesions or any pathological lymph nodes (target or non-target) having a reduction in the short axis to <10 mm. PR=at least a 30% decrease in SOD of all target lesions, taking as reference the baseline SOD, in absence of CR. PD=as at least a 20% increase in SOD of target lesions, taking as reference smallest SOD on study. DOR was analyzed using the Kaplan-Meier (KM) method. | RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR & sufficient evidence of a RET alteration. As prespecified in SAP, Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. Participants who had a response of CR/PR were analyzed in this outcome measure. Number analyzed is the number of participants with the specified mutation. | Posted | Median | 95% Confidence Interval | months | Up to approximately 79.8 months |
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| Secondary | Phase 1 and Phase 2: DOR in RET-mutation MTC Participants With Specific RET Gene Status | Oncogenic RET activation has been implicated as a driver in MTC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., M918T, cysteine rich domain, V804X). RET genotypes were determined by local testing and/or central analysis of ctDNA. DOR was assessed in participants having specific RET rearrangements. DOR=time from first documented CR/PR to date of first documented PD or death due to any cause, whichever occurs first. Per RECIST, CR= disappearance of all target lesions or any pathological lymph nodes (target or non-target) having a reduction in the short axis to <10 mm. PR=at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in absence of CR. PD=as at least a 20% increase in SOD of target lesions, taking as reference smallest SOD on study (including baseline). DOR was analyzed using the Kaplan-Meier (KM) method. | RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR & sufficient evidence of a RET alteration. As prespecified in SAP, Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. Participants who had a response of CR/PR were analyzed in this outcome measure. Number analyzed is the number of participants with the specified mutation. | Posted | Median | 95% Confidence Interval | months | Up to approximately 79.8 months |
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| Secondary | Phase 1 and Phase 2: DOR in RET-fusion Positive TC Participants With Specific RET Gene Status | Oncogenic RET activation has been implicated as a driver in MTC. These rearrangements typically produce chimeric transcripts that encode a fusion protein consisting of the RET kinase domain coupled to a protein with a dimerization domain (e.g., KIF5B, CCDC6, NCOA4). RET genotypes were determined by local testing and/or central analysis of ctDNA. DOR was assessed in participants having specific RET rearrangements. DOR=time from first documented CR/PR to date of first documented PD or death due to any cause, whichever occurs first. Per RECIST, CR= disappearance of all target lesions or any pathological lymph nodes (target or non-target) having a reduction in the short axis to <10 mm. PR=at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in absence of CR. PD=as at least a 20% increase in SOD of target lesions, taking as reference smallest SOD on study (including baseline). DOR was analyzed using the KM method. | RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR & sufficient evidence of a RET alteration. As prespecified in SAP, Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. Participants who had a response of CR/PR were analyzed in this outcome measure. Number analyzed is the number of participants with the specified mutation. | Posted | Median | 95% Confidence Interval | months | Up to approximately 79.8 months |
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| Secondary | Phase 2: DOR | DOR was defined as the time from first documented response (CR/PR) to the date of first documented PD or death due to any cause, whichever occurs first. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in the short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). DOR was analyzed using the KM methods. | RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR & sufficient evidence of a RET alteration. As prespecified in SAP, Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. Participants who had a response of CR/PR were analyzed in this OM. | Posted | Median | 95% Confidence Interval | months | Up to approximately 79.8 months |
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| Secondary | Phase 2: CBR | CBR was defined as the percentage of participants with CR or PR, or SD which has been lasting at least 16 weeks (i.e. 4 cycles if 28 days are in one cycle) from the first dose date. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in the short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). CBR and its two-sided 95% CI, which is based on the exact binomial distribution (Clopper-Pearson), were presented. | RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR and sufficient evidence of a RET alteration. As prespecified in the SAP, Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 79.8 months |
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| Secondary | Phase 2: DCR | DCR was defined as the percentage of participants with a confirmed CR/PR, or SD, per RECIST v1.1. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in the short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). DCR and its two-sided 95% CI, which is based on the exact binomial distribution (Clopper-Pearson), were presented. | RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR and sufficient evidence of a RET alteration. As prespecified in the SAP, Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 79.8 months |
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| Secondary | Phase 2: Progression-free Survival (PFS) | PFS was defined as the time from the first dose of pralsetinib to the date of first documented PD or death due to any cause, whichever occurred first. PD was defined as at least a 20% increase in SOD of target lesions, taking as reference the smallest SOD on study (including baseline). PFS was analyzed using KM methods. | Efficacy population included all participants who have been exposed to at least one dose of the study drug at the RP2D. As pre-specified in the SAP, PFS was to be assessed in participants with RET-fusion positive NSCLC, RET-mutation MTC, RET-fusion TC, and RET-fusion solid tumors other than NSCLC and TC. Hence, only the data for these arms is presented here. Overall number analyzed is the number of participants with data available for analysis. | Posted | Median | 95% Confidence Interval | months | Up to approximately 7 years |
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| Secondary | Phase 2: Overall Survival (OS) | OS was defined as the time from the first dose of pralsetinib to the date of death due to any causes. | Efficacy population included all participants who have been exposed to at least one dose of the study drug at the RP2D. As pre-specified in the SAP, OS was to be assessed in participants with RET-fusion positive NSCLC, RET-mutation MTC, RET-fusion TC, and RET-fusion solid tumors other than NSCLC and TC. Hence, only the data for these arms is presented here. | Posted | Median | 95% Confidence Interval | months | Up to approximately 7 years |
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| Secondary | Phase 2: Intracranial ORR in RET-fusion Positive NSCLC Central Nervous System (CNS) Metastases Participants | ORR=percentage of participants with CR or PR for at least 2 assessments with at least 28 days apart & no PD in between. CR=disappearance of all target CNS/brain lesion, including lesions in brain stem &/or cerebellum identified at baseline & disappearance of all non-target CNS/brain lesion at baseline & no identification of new CNS/brain lesion. PR =at least a 30% decrease in the SOD of any CNS/brain lesion, identified as RECIST 1.1 target lesions at baseline & if in the absence of unequivocal progression of any non-target CNS/brain lesion at baseline, or the identification of new CNS/brain lesion. PD=either at least 20% increase in the SOD of target CNS/brain lesion, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm or unequivocal progression of any CNS/brain lesion identified as RECIST 1.1 nontarget lesions at baseline, or the identification of new CNS/brain lesion. | RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR and sufficient evidence of a RET alteration. As specified in the SAP, ORR was to be assessed in RET-fusion CNS metastases sub-population (participants with CNS metastases) only. Hence only NSCLC arms are presented here. Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 79.8 months |
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| Secondary | Phase 2: Intracranial CBR in RET-fusion Positive NSCLC CNS Metastases Participants | CBR=percentage of participants with CR/PR/SD which has been lasting at least 16 weeks (i.e. 4 cycles if 28 days are in 1 cycle) from first dose date. CR=disappearance of all target CNS/brain lesion, including lesions in brain stem &/ cerebellum identified at baseline&disappearance of all non-target CNS/brain lesion at baseline & no identification of new CNS/brain lesion. PR=at least a 30% decrease in SOD of any CNS/brain lesion, identified as target lesions at baseline & if in absence of unequivocal progression of any non-target CNS/brain lesion at baseline, or identification of new CNS/brain lesion. SD=neither sufficient shrinkage for PR nor sufficient increase for PD for target/non-target CNS/brain lesion, taking as reference smallest SOD while on study. PD=either at least 20% increase in SOD of target CNS/brain lesion, taking as reference smallest sum on study. Unequivocal progression of any CNS/brain lesion nontarget lesions at baseline, or identification of new CNS/brain lesion. | RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR and sufficient evidence of a RET alteration. As specified in the SAP, CBR was to be assessed in RET-fusion CNS metastases sub-population (participants with CNS metastases) only. Hence only NSCLC arms are presented here. Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 79.8 months |
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| Secondary | Phase 2: Intracranial DCR in RET-fusion Positive NSCLC CNS Metastases Participants | DCR=percentage of participants with a confirmed CR/PR, or SD. CR=disappearance of all target CNS/brain lesion, including lesions in brain stem &/or cerebellum identified at baseline & disappearance of all non-target CNS/brain lesion at baseline & no identification of new CNS/brain lesion. PR =at least a 30% decrease in the SOD of any CNS/brain lesion, identified as RECIST 1.1 target lesions at baseline & if in the absence of unequivocal progression of any non-target CNS/brain lesion at baseline, or the identification of new CNS/brain lesion. SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target/non-target CNS/brain lesion, taking as reference the smallest SOD while on study. PD=either at least 20% increase in SOD of target CNS/brain lesion, taking as reference smallest sum on study. Unequivocal progression of any CNS/brain lesion nontarget lesions at baseline, or identification of new CNS/brain lesion. | RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR and sufficient evidence of a RET alteration. As specified in the SAP, DCR was to be assessed in RET-fusion CNS metastases sub-population (participants with CNS metastases) only. Hence only NSCLC arms are presented here. Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 79.8 months |
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| Secondary | Phase 2: Intracranial DOR in RET-fusion Positive NSCLC CNS Metastases Participants | DOR=time from first documented CR/PR to the date of first documented PD/death due to any cause, whichever occurs first. CR=disappearance of all target CNS/brain lesion, including lesions in brain stem &/ cerebellum identified at baseline & disappearance of all non-target CNS/brain lesion at baseline & no identification of new CNS/brain lesion. PR=at least a 30% decrease in SOD of any CNS/brain lesion, identified as RECIST 1.1 target lesions at baseline & if in absence of unequivocal progression of any non-target CNS/brain lesion at baseline, or identification of new CNS/brain lesion. PD=either at least 20% increase in SOD of target CNS/brain lesion, taking as reference smallest sum on study. Unequivocal progression of any CNS/brain lesion nontarget lesions at baseline, or identification of new CNS/brain lesion. DOR was analyzed using the KM methods. | RET-altered measurable disease population=participants in efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR&sufficient evidence of a RET alteration. As specified in SAP, DOR was to be assessed in RET-fusion CNS metastases sub-population only. Hence only NSCLC arms are presented here. Participants with a CR/PR were assessed for this OM. Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis. | Posted | Median | 95% Confidence Interval | months | Up to approximately 79.8 months |
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| Secondary | Phase 1: Maximum Plasma Concentration (Cmax) | Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | Pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliters (ng/mL) | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
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| Secondary | Phase 1: Time to Maximum Plasma Concentration (Tmax) | Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Median | Full Range | hour | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
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| Secondary | Phase 1: Time of Last Quantifiable Plasma Drug Concentration (Tlast) | The maximum values for Tlast slightly exceed 24 hours because the analysis used the actual time, i.e., the duration between dosing and actual sample collection, rather than the nominal sampling time of 24 hours specified in the protocol. The timeframe has been given as per nominal sampling timepoints pre-specified in the protocol. Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Median | Full Range | hours | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
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| Secondary | Phase 1: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Postdose (AUC0-24) | Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*nanograms/milliliter (hours*ng/ml) | 24 hours postdose on Day 1 of Cycle 1 (1 cycle = 28 days) |
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| Secondary | Phase 1: Plasma Drug Concentration at 24 Hours Postdose (C24hr) | Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
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| Secondary | Phase 1: Apparent Volume of Distribution (Vz/F) | Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
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| Secondary | Phase 1: Terminal Elimination Half-Life (t½) | The maximum values for t1/2 slightly exceed 24 hours because the analysis used the actual time, i.e., the duration between dosing and actual sample collection, rather than the nominal sampling time of 24 hours specified in the protocol. The timeframe has been given as per nominal sampling timepoints pre-specified in the protocol. Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Median | Full Range | hours | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
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| Secondary | Phase 1: Apparent Oral Clearance (CL/F) | Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters per hour (L/hr) | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
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| Secondary | Phase 1: Accumulation Ratio for Cmax (RCmax) | Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 24 hours postdose on Day 15 of Cycle 1 (1 cycle = 28 days) |
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| Secondary | Phase 1: Accumulation Ratio for AUC (RAUC) | Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM. | PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 24 hours postdose on Day 15 of Cycle 1 (1 cycle = 28 days) |
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| Secondary | Phase 2: Cmax | PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
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| Secondary | Phase 2: Tmax | PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Median | Full Range | hours | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
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| Secondary | Phase 2: Tlast | The maximum values for Tlast slightly exceed 24 hours because the analysis used the actual time, i.e., the duration between dosing and actual sample collection, rather than the nominal sampling time of 24 hours specified in the protocol. The timeframe has been given as per nominal sampling timepoints pre-specified in the protocol. | PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Median | Full Range | hours | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
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| Secondary | Phase 2: AUC0-24 | PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*ng/mL | 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
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| Secondary | Phase 2: C24hr | PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
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| Secondary | Phase 2: t½ | The maximum values for t1/2 slightly exceed 24 hours because the analysis used the actual time, i.e., the duration between dosing and actual sample collection, rather than the nominal sampling time of 24 hours specified in the protocol. The timeframe has been given as per nominal sampling timepoints pre-specified in the protocol. | PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: CL/F | PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters per hour (L/hour) | Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Phase 1: Percent Change From Baseline in Dual Specificity Phosphatase 6 (DUSP6) | The dose dependent change in a mitogen-activated protein kinases (MAPK) pathway expression signature was analyzed for all available samples of MTC and NSCLC participants. Participants with archived sample (used as baseline) and on treatment Cycle 2 Day 1 (1 cycle = 28 days) tumor tissues with greater than 20% tumor cells are included in the analysis. The changes in tumor biomarker DUSP6 levels was explored. | Safety Population included all participants who have received at least 1 dose of the study drug regardless of starting dose levels. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 4 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Phase 1: Percent Change From Baseline in Sprout Receptor Tyrosine Kinase Signaling Antagonist 4 (SPRY4) | The dose dependent change in a MAPK pathway expression signature was analyzed for all available samples of MTC and NSCLC participants. Participants with archived sample (used as baseline) and on treatment Cycle 2 Day 1 (1 cycle = 28 days) tumor tissues with greater than 20% tumor cells are included in the analysis. The changes in tumor biomarker SPRY4 levels was explored. | Safety Population included all participants who have received at least 1 dose of the study drug regardless of starting dose levels. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 4 |
|
AEs and SAEs: From Cycle 1 Day 1 up to 30 days after the final dose of study drug (up to approximately 6.7 years) All-cause Mortality: Up to approximately 7 years Safety population included all participants who have received at least 1 dose of the study drug regardless of starting dose levels.
As pre-specified in SAP, safety data was to be analyzed & reported per pre-planned grouped dose level II. Per dose level II, ≤ 300 mg QD arm included participants dosed with pralsetinib at 30 mg, 60 mg , 100 mg , 200 mg & 300 mg QD; 400 mg arm included participants dosed at 400 mg QD, BID Dosing Schedule arm included participants dosed with 100/100 mg & 200/100 mg BID, & All doses included participants treated at all QD & BID doses & 600 mg QD dose. Hence, AEs cannot be presented per dose level.
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 | Pralsetinib ≤ 300 mg QD | Participants received pralsetinib, 300 mg or less, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. | 15 | 37 | 26 | 37 | 36 | 37 |
| EG001 | Pralsetinib 400 mg QD | Participants received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. | 245 | 540 | 381 | 540 | 536 | 540 |
| EG002 | Pralsetinib BID Dosing Schedule | Participants received pralsetinib, 100 mg, orally, BID or 200 mg in the morning and then 100 mg in the evening, orally, until discontinuation due to toxicity, disease progression, or other reasons. | 7 | 9 | 7 | 9 | 9 | 9 |
| EG003 | Pralsetinib All Doses | Participants received pralsetinib at varying doses at the QD and BID schedule until discontinuation due to toxicity, disease progression, or other reasons. | 268 | 590 | 416 | 590 | 585 | 590 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Anaemia macrocytic | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Anaemia of malignant disease | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Bicytopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cardiac discomfort | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Myocardial injury | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypercalcaemia of malignancy | Endocrine disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Abdominal mass | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Noninfective sialoadenitis | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Proctitis ulcerative | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Calcinosis | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Granuloma | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Subcapsular hepatic haematoma | Hepatobiliary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Atypical mycobacterial pneumonia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Diverticulitis intestinal perforated | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Enterobacter bacteraemia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Haemophilus infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hepatitis B reactivation | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Klebsiella urinary tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Lymph node tuberculosis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Meningitis enterococcal | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pancreatic abscess | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pleural infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Psoas abscess | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Renal tuberculosis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Scrotal cellulitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Septic arthritis staphylococcal | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Sinusitis aspergillus | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Sinusitis bacterial | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Spontaneous bacterial peritonitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Chemical peritonitis | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Gastroenteritis radiation | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Immunisation reaction | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Procedural pneumothorax | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Inflammatory marker increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pseudohyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Chest wall haematoma | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Haematoma muscle | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Anaplastic large-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Bone neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Medullary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Paraneoplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Thyroid cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Tumour necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Malignant spinal cord compression | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Polyneuropathy chronic | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Radicular pain | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Vertebral artery thrombosis | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA Version 26.1 | Systematic Assessment |
| |
| Device issue | Product Issues | MedDRA Version 26.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Obstructive nephropathy | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Abnormal uterine bleeding | Reproductive system and breast disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonitis aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Spinal decompression | Surgical and medical procedures | MedDRA Version 26.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Internal haemorrhage | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Left ventricular hypertrophy | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Corneal epithelial microcysts | Eye disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Growth of eyelashes | Eye disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Gastrointestinal wall thickening | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Calcinosis | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Fungal foot infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Skin candida | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Abdominal injury | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Incision site haematoma | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Electrocardiogram repolarisation abnormality | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Breast calcifications | Reproductive system and breast disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Perioral dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Vasodilatation | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 2, 2022 | Mar 14, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D018276 | Carcinoma, Medullary |
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D013959 | Thyroid Diseases |
| D013964 | Thyroid Neoplasms |
| D000077273 | Thyroid Cancer, Papillary |
| D018278 | Carcinoma, Neuroendocrine |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D004700 | Endocrine System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D000231 | Adenocarcinoma, Papillary |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D003110 | Colonic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D018813 | Multiple Endocrine Neoplasia Type 2a |
| ID | Term |
|---|---|
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D001982 | Bronchial Diseases |
| D012002 | Rectal Diseases |
| D009377 | Multiple Endocrine Neoplasia |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C000655704 | pralsetinib |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| Other |
|
| Unknown or Not Reported |
|
Participants received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
| OG002 | Pralsetinib BID Dosing Schedule | Participants received pralsetinib, 100 mg, orally, BID or 200 mg in the morning and then 100 mg in the evening, orally, until discontinuation due to toxicity, disease progression, or other reasons. |
| OG003 | Pralsetinib All Doses | Participants received pralsetinib at varying doses at the QD and BID schedule until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
| OG001 | RET-fusion Positive NSCLC With Non-platinum Systemic Treatment | Participants who had RET-fusion positive NSCLC previously treated with non-platinum or systemic therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG002 | RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG003 | RET-mutation MTC With Prior Cabozantinib and/or Vandetanib Treatment | Participants who had RET- mutation positive MTC previously treated with either cabozantinib and/or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment | Participants who had RET- mutation positive MTC not previously treated with cabozantinib or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | RET-fusion Positive TC | Participants who had RET-fusion positive TC received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | RET-fusion Positive Solid Tumors Other Than NSCLC and TC | Participants who had other RET-positive solid tumors other than NSCLC and TC received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG007 | RET-altered Solid Tumors Previously Treated With RET Inhibitor | Participants who had RET-altered (fusion or mutation) solid tumors previously treated with a selective RET tyrosine kinase inhibitor (TKI) received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG008 | RET-mutation Positive Tumors Other Than MTC | Participants who had RET-mutation positive solid tumors received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
| Phase I: Pralsetinib 100 mg |
Participants received pralsetinib 100 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG003 | Phase I: Pralsetinib 200 mg | Participants received pralsetinib 200 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | Phase I: Pralsetinib 300 mg | Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | Phase I: Pralsetinib 400 mg | Participants received pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | Phase I: Pralsetinib 600 mg | Participants received pralsetinib 600 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG007 | Phase I: Pralsetinib 100/100 mg | Participants received pralsetinib 100 mg, orally, BID until discontinuation due to toxicity, disease progression, or other reasons. |
| OG008 | Phase I: Pralsetinib 200/100 mg | Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
| OG001 | RET-fusion Positive NSCLC With Non-platinum Systemic Treatment | Participants who had RET-fusion positive NSCLC previously treated with non-platinum or systemic therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG002 | RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
| OG001 |
| RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment |
Participants who had RET- mutation positive MTC not previously treated with cabozantinib or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| OG001 | RET-fusion Positive NSCLC With Non-platinum Systemic Treatment | Participants who had RET-fusion positive NSCLC previously treated with non-platinum or systemic therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG002 | RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
| OG001 | RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment | Participants who had RET- mutation positive MTC not previously treated with cabozantinib or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
|
|
| OG001 | RET-fusion Positive NSCLC With Non-platinum Systemic Treatment | Participants who had RET-fusion positive NSCLC previously treated with non-platinum or systemic therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG002 | RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
| OG001 | RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment | Participants who had RET- mutation positive MTC not previously treated with cabozantinib or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
|
|
Participants who had RET-fusion positive NSCLC previously treated with platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG001 | RET-fusion Positive NSCLC With Non-platinum Systemic Treatment | Participants who had RET-fusion positive NSCLC previously treated with non-platinum or systemic therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG002 | RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
Participants who had RET- mutation positive MTC previously treated with either cabozantinib and/or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
| OG001 | RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment | Participants who had RET- mutation positive MTC not previously treated with cabozantinib or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
|
|
Participants who had RET-fusion positive NSCLC previously treated with non-platinum or systemic therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG002 | RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG003 | RET-mutation MTC With Prior Cabozantinib and/or Vandetanib Treatment | Participants who had RET- mutation positive MTC previously treated with either cabozantinib and/or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment | Participants who had RET- mutation positive MTC not previously treated with cabozantinib or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | RET-fusion Positive TC | Participants who had RET-fusion positive TC received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | RET-fusion Positive Solid Tumors Other Than NSCLC and TC | Participants who had other RET-positive solid tumors other than NSCLC and TC received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG007 | RET-altered Solid Tumors Previously Treated With RET Inhibitor | Participants who had RET-altered (fusion or mutation) solid tumors previously treated with a selective RET TKI received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG008 | RET-mutation Positive Tumors Other Than MTC | Participants who had RET-mutation positive solid tumors received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
| OG001 |
| RET-fusion Positive NSCLC With Non-platinum Systemic Treatment |
Participants who had RET-fusion positive NSCLC previously treated with non-platinum or systemic therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG002 | RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG003 | RET-mutation MTC With Prior Cabozantinib and/or Vandetanib Treatment | Participants who had RET- mutation positive MTC previously treated with either cabozantinib and/or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment | Participants who had RET- mutation positive MTC not previously treated with cabozantinib or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | RET-fusion Positive TC | Participants who had RET-fusion positive TC received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | RET-fusion Positive Solid Tumors Other Than NSCLC and TC | Participants who had other RET-positive solid tumors other than NSCLC and TC received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG007 | RET-altered Solid Tumors Previously Treated With RET Inhibitor | Participants who had RET-altered (fusion or mutation) solid tumors previously treated with a selective RET TKI received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG008 | RET-mutation Positive Tumors Other Than MTC | Participants who had RET-mutation positive solid tumors received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
Participants who had RET-fusion positive NSCLC previously treated with non-platinum or systemic therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG002 | RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG003 | RET-mutation MTC With Prior Cabozantinib and/or Vandetanib Treatment | Participants who had RET- mutation positive MTC previously treated with either cabozantinib and/or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment | Participants who had RET- mutation positive MTC not previously treated with cabozantinib or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | RET-fusion Positive TC | Participants who had RET-fusion positive TC received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | RET-fusion Positive Solid Tumors Other Than NSCLC and TC | Participants who had other RET-positive solid tumors other than NSCLC and TC received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG007 | RET-altered Solid Tumors Previously Treated With RET Inhibitor | Participants who had RET-altered (fusion or mutation) solid tumors previously treated with a selective RET TKI received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG008 | RET-mutation Positive Tumors Other Than MTC | Participants who had RET-mutation positive solid tumors received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
| OG002 | RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG003 | RET-mutation MTC With Prior Cabozantinib and/or Vandetanib Treatment | Participants who had RET- mutation positive MTC previously treated with either cabozantinib and/or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment | Participants who had RET- mutation positive MTC not previously treated with cabozantinib or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | RET-fusion Positive TC | Participants who had RET-fusion positive TC received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | RET-fusion Positive Solid Tumors Other Than NSCLC and TC | Participants who had other RET-positive solid tumors other than NSCLC and TC received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
| OG003 | RET-mutation MTC With Prior Cabozantinib and/or Vandetanib Treatment | Participants who had RET- mutation positive MTC previously treated with either cabozantinib and/or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | RET-mutation MTC With No Prior Cabozantinib or Vandetanib Treatment | Participants who had RET- mutation positive MTC not previously treated with cabozantinib or vandetanib therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | RET-fusion Positive TC | Participants who had RET-fusion positive TC received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | RET-fusion Positive Solid Tumors Other Than NSCLC and TC | Participants who had other RET-positive solid tumors other than NSCLC and TC received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
Participants who had RET-fusion positive NSCLC previously treated with platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG001 | RET-fusion Positive NSCLC With Non-platinum Systemic Treatment | Participants who had RET-fusion positive NSCLC previously treated with non-platinum or systemic therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG002 | RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
Participants who had RET-fusion positive NSCLC previously treated with platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
| OG001 | RET-fusion Positive NSCLC With Non-platinum Systemic Treatment | Participants who had RET-fusion positive NSCLC previously treated with non-platinum or systemic therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG002 | RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
Participants who had RET-fusion positive NSCLC previously treated with platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
| OG001 | RET-fusion Positive NSCLC With Non-platinum Systemic Treatment | Participants who had RET-fusion positive NSCLC previously treated with non-platinum or systemic therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG002 | RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
| OG001 | RET-fusion Positive NSCLC With Non-platinum Systemic Treatment | Participants who had RET-fusion positive NSCLC previously treated with non-platinum or systemic therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG002 | RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
| OG003 | Phase I: Pralsetinib 200 mg | Participants received pralsetinib 200 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | Phase I: Pralsetinib 300 mg | Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | Phase I: Pralsetinib 400 mg | Participants received pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | Phase I: Pralsetinib 600 mg | Participants received pralsetinib 600 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG007 | Phase I: Pralsetinib 100/100 mg | Participants received pralsetinib 100 mg, orally, BID until discontinuation due to toxicity, disease progression, or other reasons. |
| OG008 | Phase I: Pralsetinib 200/100 mg | Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
| OG003 | Phase I: Pralsetinib 200 mg | Participants received pralsetinib 200 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | Phase I: Pralsetinib 300 mg | Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | Phase I: Pralsetinib 400 mg | Participants received pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | Phase I: Pralsetinib 600 mg | Participants received pralsetinib 600 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG007 | Phase I: Pralsetinib 100/100 mg | Participants received pralsetinib 100 mg, orally, BID until discontinuation due to toxicity, disease progression, or other reasons. |
| OG008 | Phase I: Pralsetinib 200/100 mg | Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
| OG002 | Phase I: Pralsetinib 100 mg | Participants received pralsetinib 100 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG003 | Phase I: Pralsetinib 200 mg | Participants received pralsetinib 200 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | Phase I: Pralsetinib 300 mg | Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | Phase I: Pralsetinib 400 mg | Participants received pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | Phase I: Pralsetinib 600 mg | Participants received pralsetinib 600 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG007 | Phase I: Pralsetinib 100/100 mg | Participants received pralsetinib 100 mg, orally, BID until discontinuation due to toxicity, disease progression, or other reasons. |
| OG008 | Phase I: Pralsetinib 200/100 mg | Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
| OG003 | Phase I: Pralsetinib 200 mg | Participants received pralsetinib 200 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | Phase I: Pralsetinib 300 mg | Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | Phase I: Pralsetinib 400 mg | Participants received pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | Phase I: Pralsetinib 600 mg | Participants received pralsetinib 600 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG007 | Phase I: Pralsetinib 100/100 mg | Participants received pralsetinib 100 mg, orally, BID until discontinuation due to toxicity, disease progression, or other reasons. |
| OG008 | Phase I: Pralsetinib 200/100 mg | Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
| OG003 | Phase I: Pralsetinib 200 mg | Participants received pralsetinib 200 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | Phase I: Pralsetinib 300 mg | Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | Phase I: Pralsetinib 400 mg | Participants received pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | Phase I: Pralsetinib 600 mg | Participants received pralsetinib 600 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG007 | Phase I: Pralsetinib 100/100 mg | Participants received pralsetinib 100 mg, orally, BID until discontinuation due to toxicity, disease progression, or other reasons. |
| OG008 | Phase I: Pralsetinib 200/100 mg | Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons. |
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Participants received pralsetinib 100 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
| OG003 | Phase I: Pralsetinib 200 mg | Participants received pralsetinib 200 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | Phase I: Pralsetinib 300 mg | Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | Phase I: Pralsetinib 400 mg | Participants received pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | Phase I: Pralsetinib 600 mg | Participants received pralsetinib 600 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG007 | Phase I: Pralsetinib 100/100 mg | Participants received pralsetinib 100 mg, orally, BID until discontinuation due to toxicity, disease progression, or other reasons. |
| OG008 | Phase I: Pralsetinib 200/100 mg | Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons. |
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| OG002 | Phase I: Pralsetinib 100 mg | Participants received pralsetinib 100 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG003 | Phase I: Pralsetinib 200 mg | Participants received pralsetinib 200 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | Phase I: Pralsetinib 300 mg | Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | Phase I: Pralsetinib 400 mg | Participants received pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | Phase I: Pralsetinib 600 mg | Participants received pralsetinib 600 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG007 | Phase I: Pralsetinib 100/100 mg | Participants received pralsetinib 100 mg, orally, BID until discontinuation due to toxicity, disease progression, or other reasons. |
| OG008 | Phase I: Pralsetinib 200/100 mg | Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons. |
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Participants received pralsetinib 100 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
| OG003 | Phase I: Pralsetinib 200 mg | Participants received pralsetinib 200 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | Phase I: Pralsetinib 300 mg | Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | Phase I: Pralsetinib 400 mg | Participants received pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | Phase I: Pralsetinib 600 mg | Participants received pralsetinib 600 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG007 | Phase I: Pralsetinib 100/100 mg | Participants received pralsetinib 100 mg, orally, BID until discontinuation due to toxicity, disease progression, or other reasons. |
| OG008 | Phase I: Pralsetinib 200/100 mg | Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons. |
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|
| OG003 | Phase I: Pralsetinib 200 mg | Participants received pralsetinib 200 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | Phase I: Pralsetinib 300 mg | Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | Phase I: Pralsetinib 400 mg | Participants received pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | Phase I: Pralsetinib 600 mg | Participants received pralsetinib 600 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG007 | Phase I: Pralsetinib 100/100 mg | Participants received pralsetinib 100 mg, orally, BID until discontinuation due to toxicity, disease progression, or other reasons. |
| OG008 | Phase I: Pralsetinib 200/100 mg | Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons. |
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|
| OG003 | Phase I: Pralsetinib 200 mg | Participants received pralsetinib 200 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | Phase I: Pralsetinib 300 mg | Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | Phase I: Pralsetinib 400 mg | Participants received pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | Phase I: Pralsetinib 600 mg | Participants received pralsetinib 600 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG007 | Phase I: Pralsetinib 100/100 mg | Participants received pralsetinib 100 mg, orally, BID until discontinuation due to toxicity, disease progression, or other reasons. |
| OG008 | Phase I: Pralsetinib 200/100 mg | Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons. |
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| OG003 | RET-mutation Positive Tumors Other Than MTC Participants | Participants who had RET-mutation positive solid tumors received Pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data. |
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| OG003 | RET-mutation Positive Tumors Other Than MTC Participants | Participants who had RET-mutation positive solid tumors received Pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data. |
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| OG002 | RET-altered Solid Tumors Participants | Participants who had RET-altered (fusion or mutation) solid tumors previously treated with a selective RET TKI received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data. |
| OG003 | RET-mutation Positive Tumors Other Than MTC Participants | Participants who had RET-mutation positive solid tumors received Pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data. |
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| OG003 | RET-mutation Positive Tumors Other Than MTC Participants | Participants who had RET-mutation positive solid tumors received Pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data. |
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|
| OG003 | RET-mutation Positive Tumors Other Than MTC Participants | Participants who had RET-mutation positive solid tumors received Pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data. |
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|
| OG002 | RET-altered Solid Tumors Participants | Participants who had RET-altered (fusion or mutation) solid tumors previously treated with a selective RET TKI received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data. |
| OG003 | RET-mutation Positive Tumors Other Than MTC Participants | Participants who had RET-mutation positive solid tumors received Pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data. This arm was specifically planned for reporting PK data. |
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|
| OG003 | RET-mutation Positive Tumors Other Than MTC Participants | Participants who had RET-mutation positive solid tumors received Pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. This arm was specifically planned for reporting PK data. This arm was specifically planned for reporting PK data. |
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|
| OG003 | Phase I: Pralsetinib 200 mg | Participants received pralsetinib 200 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | Phase I: Pralsetinib 300 mg | Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | Phase I: Pralsetinib 400 mg | Participants received pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | Phase I: Pralsetinib 600 mg | Participants received pralsetinib 600 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG007 | Phase I: Pralsetinib 100/100 mg | Participants received pralsetinib 100 mg, orally, BID until discontinuation due to toxicity, disease progression, or other reasons. |
| OG008 | Phase I: Pralsetinib 200/100 mg | Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons. |
|
|
| OG003 | Phase I: Pralsetinib 200 mg | Participants received pralsetinib 200 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG004 | Phase I: Pralsetinib 300 mg | Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG005 | Phase I: Pralsetinib 400 mg | Participants received pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG006 | Phase I: Pralsetinib 600 mg | Participants received pralsetinib 600 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons. |
| OG007 | Phase I: Pralsetinib 100/100 mg | Participants received pralsetinib 100 mg, orally, BID until discontinuation due to toxicity, disease progression, or other reasons. |
| OG008 | Phase I: Pralsetinib 200/100 mg | Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons. |
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