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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000459-11 | EudraCT Number |
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| Name | Class |
|---|---|
| BeiGene | INDUSTRY |
| Jazz Pharmaceuticals Ireland Limited | INDUSTRY |
| BeOne Medicines LTD | UNKNOWN |
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This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or metastatic biliary tract cancer (BTC), including intra-hepatic cholangiocarcinoma (ICC), extra-hepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZW25 (Zanidatamab) Monotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZW25 (Zanidatamab) | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR) | Number of participants who achieved a confirmed best overall response (BOR) of either complete response (CR) or partial response (PR) during treatment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR) is defined as a disappearance of all target and non-target lesions and partial response (PR) is defined as at least a 30% decrease in the sum of diameters of all target lesions. | Up to 34 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) by ICR | The time from the first confirmed objective response (CR or PR) to documented progressive disease (PD) per RECIST 1.1, or death from any cause | Up to 45 months |
| DOR ≥ 16 Weeks by ICR |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| University of Arizona Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39114870 | Derived | Harding JJ, Fan J, Oh DY, Choi HJ, Kim JW, Chang HM, Bao L, Sun HC, Macarulla T, Xie F, Metges JP, Ying J, Bridgewater J, Lee MA, Tejani MA, Chen EY, Kim DU, Wasan H, Ducreux M, Bao Y, Lindsey S, Bachini M, Morement H, Boyken L, Ma J, Garfin P, Pant S; HERIZON-BTC-01 study group. A plain language summary of the results from the phase 2b HERIZON-BTC-01 study of zanidatamab in participants with HER2-amplified biliary tract cancer. Future Oncol. 2024;20(31):2319-2329. doi: 10.1080/14796694.2024.2368952. Epub 2024 Aug 8. | |
| 37276871 |
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In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
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Participants must have received at least 1 prior gemcitabine-containing systemic chemotherapy regimen for advanced disease and experienced disease progression after or developed intolerance to the most recent prior therapy.
A total of 87 participants who met all eligibility criteria were enrolled and received treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort I | Participants with advanced or metastatic biliary tract cancer with HER2 amplification by in situ hybridization (ISH) and HER2 overexpression by immunohistochemistry (IHC) which includes IHC 2+ or 3+ |
| FG001 | Cohort II |
| 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 | Sep 8, 2023 | Jul 26, 2024 |
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single-arm, open-label, multi-cohort, multicenter study
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Proportion of subjects with a DOR ≥ 16 weeks per RECIST 1.1
| 24 weeks, up to 45 months |
| Disease Control Rate (DCR) by ICR | Number of subjects who achieved a best overall response of stable disease (SD), non-CR/non-PD, or confirmed CR or PR per RECIST 1.1 | Up to 45 months |
| Progression-free Survival (PFS) by ICR | The time from the first dose of study treatment to the date of documented disease progression (per RECIST 1.1), or death from any cause | Up to 45 months |
| ORR by Investigator Assessment | Number of subjects who achieved a confirmed BOR of either CR or PR during treatment per RECIST 1.1 | Up to 45 months |
| DOR by Investigator Assessment | The time from the first confirmed objective response (CR or PR) to documented progressive disease (PD) per RECIST 1.1, or death from any cause | Up to 45 months |
| DOR ≥ 16 Weeks by Investigator Assessment | Proportion of subjects with a DOR ≥ 16 weeks per RECIST 1.1 | 24 weeks, up to 45 months |
| DCR by Investigator Assessment | Number of subjects who achieved a best overall response of stable disease (SD), non-CR/non-PD, or confirmed CR or PR per RECIST 1.1 | Up to 45 months |
| PFS by Investigator Assessment | The time from the first dose of study treatment to the date of documented disease progression (per RECIST 1.1), or death from any cause | Up to 45 months |
| Overall Survival | The time from the first dose of study treatment until the date of death from any cause | Up to 45 months |
| Incidence of Adverse Events (AEs) | Number of subjects who experienced AEs or serious adverse events | Up to 45 months |
| Incidence of Laboratory Abnormalities | Number of subjects who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 | Up to 45 months |
| Maximum Serum Concentration of ZW25 | Pre-dose, end of infusion, 2, 4, 8, 24 and 96 hours post dose |
| Trough Concentration of ZW25 | Minimum observed serum concentration (trough) | Pre-dose, end of infusion, 2, 4, 8, 24 and 96 hours post dose |
| Incidence of Anti-drug Antibodies (ADAs) | Number of subjects who develop ADAs | Up to 45 months |
| Tucson |
| Arizona |
| 95724 |
| United States |
| City of Hope National Medical Center | Duarte | California | 91010 | United States |
| University of California Los Angeles | Santa Monica | California | 90404 | United States |
| The Oncology Institute of Hope and Innovation | Whittier | California | 90603 | United States |
| Advent Health Cancer Institute | Orlando | Florida | 32804 | United States |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | United States |
| University of Maryland Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| University of Texas Southwestern Medical Center - Hospital | Dallas | Texas | 75390 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Centro de Cáncer Nuestra Señora de la Esperanza | Santiago | 8330032 | Chile |
| Radiomed (Clinica Alemana de Temuco) | Temuco | 645 | Chile |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| Peking Union Medical College Hospital | Beijing | 100730 | China |
| Jilin Cancer Hospital | Changchun | 130012 | China |
| Hunan Cancer Hospital | Changsha | 410013 | China |
| West China Hospital | Chengdu | 610041 | China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | 510080 | China |
| The First Affiliated Hospital of Zhejiang University | Hangzhou | 310003 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | 310014 | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | 310016 | China |
| Zhejiang Cancer Hospital | Hangzhou | 310022 | China |
| Affiliated Tumor Hospital of Harbin Medical University | Harbin | 150081 | China |
| Anhui Provincial Hospital | Hefei | 230001 | China |
| Huzhou Central Hospital | Huzhou | 313000 | China |
| Jinhua Central Hospital | Jinhua | 321000 | China |
| The First Hospital Of Lanzhou University | Lanzhou | 730000 | China |
| Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School | Nanjing | 210008 | China |
| Shandong Provincial Third Hospital | Shandong | 250031 | China |
| Affiliated Zhongshan Hospital of Fudan University | Shanghai | 200032 | China |
| The Third Affiliated Hospital of the Chinese PLA | Shanghai | 200081 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | 300060 | China |
| Weifang People's Hospital | Weifang | 261000 | China |
| Hubei Cancer Hospital | Wuhan | 430079 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | 450052 | China |
| Oncologie médicale Hopital Jean Minjoz | Besançon | 25030 | France |
| Institut de Cancerologie et d'Hematologie Hopital Morvan - CHRU de Brest | Brest | 29200 | France |
| Hopitaux de La Timone | Marseille | 13385 | France |
| Département Oncologie Gastro-entérologie CHRU de Poitiers La Miletrie | Poitiers | 86000 | France |
| Département De Médecine | Villejuif | 94805 | France |
| Fondazione del Piemonte per l'Oncologia (IRCCS) | Candiolo | 10060 | Italy |
| Istituto Clinico Humanitas | Milan | 20089 | Italy |
| Istituto Nazionale Dei Tumori | Milan | 20133 | Italy |
| Istituto Oncologico Veneto - I.R.C.C.S. | Padova | 35128 | Italy |
| Gyeongsang National University Hospital | Jinju | 52727 | South Korea |
| Pusan National University Hospital | Pusan | 49241 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center Hospital | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Universitario Germans Trias i Pujol | Barcelona | 08916 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Universitario Doce de Octubre | Madrid | 28041 | Spain |
| Corporacio Sanitaria Parc Tauli | Sabadell | 08208 | Spain |
| Hospital Miguel Servet | Zaragoza | 50009 | Spain |
| University College London Hospitals (UCLH) | London | NW1 2PG | United Kingdom |
| Royal Free London NHS Foundation Trust | London | NW3 2QG | United Kingdom |
| Imperial College Healthcare NHS Trust | London | W12 0HS | United Kingdom |
| Derived |
| Harding JJ, Fan J, Oh DY, Choi HJ, Kim JW, Chang HM, Bao L, Sun HC, Macarulla T, Xie F, Metges JP, Ying J, Bridgewater J, Lee MA, Tejani MA, Chen EY, Kim DU, Wasan H, Ducreux M, Bao Y, Boyken L, Ma J, Garfin P, Pant S; HERIZON-BTC-01 study group. Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): a multicentre, single-arm, phase 2b study. Lancet Oncol. 2023 Jul;24(7):772-782. doi: 10.1016/S1470-2045(23)00242-5. Epub 2023 Jun 2. |
Participants with advanced or metastatic biliary tract cancer with HER2 amplification by ISH and HER2 IHC 0 or 1+.
| COMPLETED |
|
| NOT COMPLETED |
|
|
The baseline demographic characteristics were assessed in the Safety Analysis Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort I | Participants with advanced or metastatic biliary tract cancer with HER2 amplification by in situ hybridization (ISH) and HER2 overexpression by immunohistochemistry (IHC) which includes IHC 2+ or 3+ |
| BG001 | Cohort II | Participants with advanced or metastatic biliary tract cancer with HER2 amplification by ISH and HER2 IHC 0 or 1+. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR) | Number of participants who achieved a confirmed best overall response (BOR) of either complete response (CR) or partial response (PR) during treatment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR) is defined as a disappearance of all target and non-target lesions and partial response (PR) is defined as at least a 30% decrease in the sum of diameters of all target lesions. | Assessed in participants with available data in the Efficacy Analysis Set. | Posted | Count of Participants | Participants | No | Up to 34 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) by ICR | The time from the first confirmed objective response (CR or PR) to documented progressive disease (PD) per RECIST 1.1, or death from any cause | Only participants with a response (a confirmed Complete Response (CR) or confirmed Partial Response (PR)), as evaluated by ICR, were evaluated for this outcome. | Posted | Median | 95% Confidence Interval | months | Up to 45 months |
|
| |||||||||||||||||||||||||||||
| Secondary | DOR ≥ 16 Weeks by ICR | Proportion of subjects with a DOR ≥ 16 weeks per RECIST 1.1 | Only participants with a response (a confirmed Complete Response (CR) or confirmed Partial Response (PR)), as evaluated by ICR, were evaluated for this outcome. | Posted | Count of Participants | Participants | No | 24 weeks, up to 45 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) by ICR | Number of subjects who achieved a best overall response of stable disease (SD), non-CR/non-PD, or confirmed CR or PR per RECIST 1.1 | Posted | Count of Participants | Participants | No | Up to 45 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) by ICR | The time from the first dose of study treatment to the date of documented disease progression (per RECIST 1.1), or death from any cause | Posted | Median | 95% Confidence Interval | months | Up to 45 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | ORR by Investigator Assessment | Number of subjects who achieved a confirmed BOR of either CR or PR during treatment per RECIST 1.1 | Posted | Count of Participants | Participants | No | Up to 45 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | DOR by Investigator Assessment | The time from the first confirmed objective response (CR or PR) to documented progressive disease (PD) per RECIST 1.1, or death from any cause | Only participants with a response (a confirmed Complete Response (CR) or confirmed Partial Response (PR)) as per investigator assessment, were evaluated for this outcome. | Posted | Median | 95% Confidence Interval | months | Up to 45 months |
|
| |||||||||||||||||||||||||||||
| Secondary | DOR ≥ 16 Weeks by Investigator Assessment | Proportion of subjects with a DOR ≥ 16 weeks per RECIST 1.1 | Only participants with a response (a confirmed Complete Response (CR) or confirmed Partial Response (PR)) as per investigator assessment, were evaluated for this outcome. | Posted | Count of Participants | Participants | No | 24 weeks, up to 45 months |
|
| |||||||||||||||||||||||||||||
| Secondary | DCR by Investigator Assessment | Number of subjects who achieved a best overall response of stable disease (SD), non-CR/non-PD, or confirmed CR or PR per RECIST 1.1 | Posted | Count of Participants | Participants | No | Up to 45 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | PFS by Investigator Assessment | The time from the first dose of study treatment to the date of documented disease progression (per RECIST 1.1), or death from any cause | Posted | Median | 95% Confidence Interval | months | Up to 45 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival | The time from the first dose of study treatment until the date of death from any cause | Posted | Median | 95% Confidence Interval | months | Up to 45 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Incidence of Adverse Events (AEs) | Number of subjects who experienced AEs or serious adverse events | Posted | Count of Participants | Participants | No | Up to 45 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Incidence of Laboratory Abnormalities | Number of subjects who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 | Posted | Count of Participants | Participants | No | Up to 45 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Maximum Serum Concentration of ZW25 | All subjects who received any amount of zanidatamab and have at least 1 post-baseline PK assessment were included in this outcome | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter | Pre-dose, end of infusion, 2, 4, 8, 24 and 96 hours post dose |
|
| ||||||||||||||||||||||||||||||
| Secondary | Trough Concentration of ZW25 | Minimum observed serum concentration (trough) | All subjects who received any amount of zanidatamab and have at least 1 post-baseline pharmacokinetic (PK) assessment were included in this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter | Pre-dose, end of infusion, 2, 4, 8, 24 and 96 hours post dose |
|
| |||||||||||||||||||||||||||||
| Secondary | Incidence of Anti-drug Antibodies (ADAs) | Number of subjects who develop ADAs | All subjects who received any amount of zanidatamab and have both baseline anti-drug antibodies (ADA) and at least 1 post baseline ADA results available were included in this outcome | Posted | Count of Participants | Participants | No | Up to 45 months |
|
|
Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 45 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort I | Participants with advanced or metastatic biliary tract cancer with HER2 amplification by in situ hybridization (ISH) and HER2 overexpression by immunohistochemistry (IHC) which includes IHC 2+ or 3+ | 60 | 80 | 43 | 80 | 78 | 80 |
| EG001 | Cohort II | Participants with advanced or metastatic biliary tract cancer with HER2 amplification by ISH and HER2 IHC 0 or 1+. | 6 | 7 | 3 | 7 | 5 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Cholangitis infective | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Duodenal obstruction | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Duodenal stenosis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Paraneoplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal lymphadenopathy | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haematochezia | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoproteinemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Peripheral sesory neuropathy | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure & Transparency | Jazz Pharmaceuticals Inc. | 215-832-3750 | ClinicalTrialDisclosure@JazzPharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 28, 2022 | Jul 26, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D005706 | Gallbladder Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000726995 | zanidatamab |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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