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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001976-14 | EudraCT Number |
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| Name | Class |
|---|---|
| Institut de Recherches Internationales Servier | OTHER |
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This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.
This is an international, open-label, controlled two-arm, randomised phase III study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC. The analysis will be done after 331 events are reported. In order to observe this number of events, 490 patients will be randomised (1:1) to receive trifluridine/tipiracil in combination with bevacizumab (experimental arm) or trifluridine/tipiracil monotherapy (control arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trifluridine/Tipiracil + Bevacizumab | Experimental | Participants were administered 35 milligrams per square meter per dose (mg/m²/dose) trifluridine/tipiracil (FTD/TPI) orally twice a day (BID), within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 an Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab (5 milligrams per kilogram [mg/kg], intravenous [IV] infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks. |
|
| Trifluridine/Tipiracil | Active Comparator | Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trifluridine/Tipiracil | Drug | Taken by mouth two times a day, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. | From date of randomization to the death due to any cause or cut-off date, whichever comes first (maximum duration: up to 20 months) |
| Survival Probability at 6 Months | Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 6 months was reported. | From date of randomization until 6 months post treatment |
| Survival Probability at 12 Months | Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 12 months was reported. | From date of randomization until 12 months post treatment |
| Survival Probability at 18 Months | Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 18 months was reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was defined as the time elapsed between the date of randomisation and the date of radiological tumour progression as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by investigator, or death (from any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. |
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Inclusion Criteria:
Exclusion Criteria:
More than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer.
Pregnancy, lactating female or possibility of becoming pregnant during the study.
Patients currently receiving or having received anticancer therapies within 4 weeks prior to randomization.
Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to randomization (excluding alopecia, and skin pigmentation).
Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
Has severe or uncontrolled active acute or chronic infection.
Has active or history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
Known Hepatitis B or Hepatitis C Virus infection.
Known carriers of HIV antibodies.
Confirmed uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg) or uncontrolled or symptomatic arrhythmia.
Deep arterial thromboembolic events including cerebrovascular accident or myocardial infarction within the last 6 months prior to randomization.
Treatment with any of the following within the specified time frame prior to randomization:
Other clinically significant medical conditions.
Other malignancies.
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| Name | Affiliation | Role |
|---|---|---|
| Josep Tabernero, Prof | Vall d'Hebron Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | United States | ||
| City of Hope |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37133585 | Result | Prager GW, Taieb J, Fakih M, Ciardiello F, Van Cutsem E, Elez E, Cruz FM, Wyrwicz L, Stroyakovskiy D, Papai Z, Poureau PG, Liposits G, Cremolini C, Bondarenko I, Modest DP, Benhadji KA, Amellal N, Leger C, Vidot L, Tabernero J; SUNLIGHT Investigators. Trifluridine-Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer. N Engl J Med. 2023 May 4;388(18):1657-1667. doi: 10.1056/NEJMoa2214963. | |
| 38953855 |
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Randomization (1:1 ratio): stratified by geographic region (North America, European Union, Rest of the World), time since 1st metastasis diagnosis (less than [<] 18 months, greater than or equal to [>=] 18 months) and rat sarcoma virus status (wild-type, mutant). Primary analysis of overall survival as primary outcome measure was completed with cutoff date of July 19, 2022; no efficacy analysis was conducted after this cutoff and participants were continued to be followed for safety analysis.
The study was conducted at 99 active sites in 13 countries. A total of 659 participants were screened, of which 492 participants were randomized and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trifluridine/Tipiracil + Bevacizumab | Participants were administered 35 milligrams per square meter per dose (mg/m²/dose) trifluridine/tipiracil (FTD/TPI) orally twice a day (BID), within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab (5 milligrams per kilogram [mg/kg], intravenous [IV] infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks. |
| 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 30, 2020 | Oct 16, 2023 |
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|
| Bevacizumab | Drug | administered every 2 weeks (Day 1 and Day 15) |
|
|
| From date of randomization until 18 months post treatment |
| From randomization to the date of radiological tumour progression or death due to any cause or data cut-off date whichever comes first (i.e., up to 20 months) |
| Probability of Participants With Progression Free Survival at 3, 6, 9 and 12 Months | PFS was defined as the time elapsed between the date of randomisation and the date of radiological tumour progression as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by investigator, or death (from any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. In this outcome measure, data of PFS at 3 months was reported. | From randomization until 3, 6, 9, and 12 months post treatment |
| Overall Response Rate (ORR) | Objective response was defined as percentage of participants who achieved complete response (CR) or partial response (PR) according to the RECIST version 1.1 and using investigator's tumour assessment. As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. | From the date of randomization to the date of documentation of progression or death due to any cause or data cut-off, whichever occurred first (i.e., up to 20 months) |
| Percentage of Participants With Disease Control | Disease control is defined as percentage of participants who achieved CR or PR, or stable disease (SD) as per RECIST 1.1 and using investigator's tumour assessment from the date of randomization to until disease progression or death due to any cause. As per RECIST 1.1, CR: disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. | From randomization to the date of first documented tumor progression, death due to any cause or data cut-off date whichever comes first (i.e., up to 20 months) |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs) | An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (time from the first dose of study treatment up to 30 days after the last dose of study treatment). TEAEs included both SAEs and non-SAEs. | From baseline (Cycle 1 Day 1) up to 30 days after the last dose of study drug (i.e., up to 30.7 months) |
| European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30): Time to Definitive Deterioration of >=10 Points in Sub-scale Scores - Kaplan-Meier Analysis | EORTC QLQ-C30: 30 item questionnaires with 5 multi-item functional subscales (physical, role, cognitive, emotional, social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), global health/quality of life (QOL) subscale and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation and financial impact of cancer). It employed twenty-eight 4-point Likert scales with responses from "not at all" to "very much" and GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional & GHS/QoL = higher level of functioning, & higher score for symptoms scales = higher symptom burden. Time to definitive >=10 points deterioration: time from date of randomization to first deterioration in QoL score >=10 points compared to baseline with no later improvement or death due to any cause. Kaplan-Meier method was used. | Date of randomization to first deterioration in QoL score >=10 points or death due to any cause, which ever occurred first (i.e., up to 20 months) |
| European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30): Time to Definitive Deterioration of >=10 Points in the Global Health Status Score - Kaplan-Meier Analysis | EORTC QLQ-C30: 30 item questionnaires composed of 5 multi-item functional subscales (physical, role, cognitive, emotional, social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), global health/QOL subscale and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation and financial impact of cancer). It employed twenty-eight 4-point Likert scales with responses from "not at all" to "very much" and GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional & GHS/QoL = higher level of functioning, & higher score for symptoms scales = higher symptom burden. Time to definitive >=10 points deterioration: time from date of randomization to the first deterioration in QoL score >=10 points compared to baseline with no later improvement or death due to any cause. Kaplan-Meier method was used. | Date of randomization to first deterioration in QoL score >=10 points or death due to any cause, which ever occurred first (i.e., up to 20 months) |
| Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints | The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health utility and consist in 2 sections a descriptive system comprising 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and Visual Analog Scale (VAS). Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state. | Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11, Cycle 12, Cycle 13 and Cycle 14 |
| Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints | The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health utility and consist of 2 sections; descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a VAS. The VAS records the respondent's self-rated health on a 20 centimeter (cm) vertical VAS; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). This information can be used as a quantitative measure of health as judged by the individual respondents. | Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11, Cycle 12, Cycle 13 and Cycle 14 |
| Duarte |
| California |
| 91010 |
| United States |
| City of Hope - South Pasedena | South Pasadena | California | 91030 | United States |
| City of Hope - Upland | Upland | California | 91786 | United States |
| Mayo Clinic - FL | Jacksonville | Florida | 32224 | United States |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | United States |
| Comprehensive Hematology Oncology | St. Petersburg | Florida | 33709 | United States |
| DuPage Medical Group - Joliet Oncology-Hematology Associates | Joliet | Illinois | 60435 | United States |
| Investigative Clinical Research of Indiana LLC | Noblesville | Indiana | 46062 | United States |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | United States |
| Mayo Clinic - Rochester | Rochester | New York | 55905 | United States |
| Renovatio Clinical - El Paso | El Paso | Texas | 79915 | United States |
| "Medizinische Universität Graz " | Graz | 8036 | Austria |
| "Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V" | Innsbruck | 6020 | Austria |
| "Ordensklinikum Linz Barmherzige Schwestern Interne I" | Linz | 4010 | Austria |
| "Landeskrankenhaus Feldkirch Interne E" | Rankweil | 6830 | Austria |
| "Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)" | Salzburg | 5020 | Austria |
| "Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie" | Vienna | 1090 | Austria |
| "Landesklinikum Wiener Neustadt " | Wiener Neustadt | 2700 | Austria |
| "OLV Ziekenhuis Oncology" | Aalst | 9300 | Belgium |
| "Universitair Ziekenhuis Antwerpen Oncologie" | Edegem | 2650 | Belgium |
| "UZ Leuven Campus Gasthuisberg Digestieve Oncologie" | Leuven | 3000 | Belgium |
| "CHC Montlégia Oncologie" | Liège | 4000 | Belgium |
| "AZ NIKOLAAS Oncology" | Sint-Niklaas | 9100 | Belgium |
| "Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica" | Barretos | 14784-400 | Brazil |
| "Hospital de Base Centro Integrado de Pesquisa" | São José do Rio Preto | 15090-000 | Brazil |
| "ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa" | São Paulo | 01246-000 | Brazil |
| Hospital A C Camargo Unidade de Pesquisa Clinica Rua Antonio Prudente | São Paulo | 01509-900 | Brazil |
| Hospital Sao Camilo Nucleo de Pesquisa Av Alcantara Machado | São Paulo | 03102-002 | Brazil |
| Hospital Albert Einstein Instituto de Ensino e Pesquisa Av Albert Einstein | São Paulo | 05652- 900 | Brazil |
| "Aalborg Universitetshospital, Syd Onkologisk Afdeling" | Aalborg | 9000 | Denmark |
| Rigshospitalet Dpt of Oncology | Copenhagen | 2100 | Denmark |
| "Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling" | Herning | 7400 | Denmark |
| "Odense Universitetshospital Department of Oncology" | Odense | 5000 | Denmark |
| "CHU Jean Minjoz Service d'oncologie médicale" | Besançon | 25030 | France |
| "CHU Morvan Institut de Cancérologie et d'Hématologie" | Brest | 29200 | France |
| "Centre de lutte contre le cancer Francois Baclesse UCP Digestif" | Caen | 14076 | France |
| Hôpital Saint-Antoine Service d'Oncologie Médicale | Paris | 75012 | France |
| "Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive" | Paris | 75015 | France |
| CHU de Poitiers Pole Régional de Cancérologie | Poitiers | 86021 | France |
| Onkologische Schwerpunktpraxis Kurfuerstendamm | Berlin | 10707 | Germany |
| Charite Universitätsmedizin Medizinische Klinik m.S. Haemat., Onko., Tumorimmunologie | Berlin | 13353 | Germany |
| Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei | Lübeck | 23562 | Germany |
| Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III | München | 81377 | Germany |
| Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly | Budapest | 1062 | Hungary |
| Szent Imre Egyetemi Oktatokorhaz Klinikai Onkologiai Osztaly | Budapest | 1115 | Hungary |
| Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet | Debrecen | 4032 | Hungary |
| Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly | Győr | 9024 | Hungary |
| Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont | Kecskemét | 6000 | Hungary |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika | Szeged | 6720 | Hungary |
| JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum | Szolnok | 5004 | Hungary |
| Markusovszky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly | Szombathely | 9700 | Hungary |
| Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica Strada Statale 554 Sestu-Monserrato | Cagliari | Italiy | 9100 | Italy |
| A.O.U. Seconda Universita degli Studi di Napoli U.O.C di Oncologia Medica e di Ematologia Dipartimento Medico di Internistica clinca e sperimentale " F Magrassi - A. Lanzara" Via Sergio Pansisni , | Naples | 80131 | Italy |
| Istituto Nazionale Tumori, I.R.C.C.S "Fondazione G Pascale" Struttura Complessa di Oncologia Medica Addominale | Naples | 80131 | Italy |
| Istituto Oncologico Veneto IOV - IRCCS Unita Operativa Complessa Oncologia Medica 1 Via Gattamelata 64 | Padova | 35128 | Italy |
| A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2 | Pisa | 56126 | Italy |
| Ospedale San Carlo U.O. Oncologia Medica Via Potito Petrone, Ctr Macchia Romana | Potenza | 85100 | Italy |
| Arcispedale Santa Maria Nuova Unità di Oncologia | Reggio Emilia | 42123 | Italy |
| Istituto Clinico Humanita IRCCS Dipartimento di Oncologia Medica ed Ematologia Via Manzoni, | Rozzano (MI) | 20089 | Italy |
| IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia Vale Cappuccini 1 | San Giovanni Rotondo | 71013 | Italy |
| Przychodnia Lekarska "KOMED" | Konin | 62-500 | Poland |
| SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii | Krakow | 31-531 | Poland |
| Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej | Opole | 45-061 | Poland |
| Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o. | Słupsk | 76-200 | Poland |
| Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy Klinika Onkologii i Radioterapii | Warsaw | 02-034 | Poland |
| Wojskowy Instytut Medyczny Klinika Onkologii | Warsaw | 04-141 | Poland |
| Centralny Szpital Kliniczny MSWiA Oddział Radioterapii i Onkologii | Warzszawa | 02-507 | Poland |
| Pan American Center for Oncology Trials, LLC | Río Piedras | Porto RICO | 00935 | Puerto Rico |
| Arkhangelsk Clinical Oncology Dispensary chemotherapy department | Arkhangelsk | 163045 | Russia |
| Clinical Oncology Dispensary No.1 Chemotherapy Department | Krasnodar | 350040 | Russia |
| Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy | Moscow | 115478 | Russia |
| University Headache Clinic Outpatient oncology clinic | Moscow | 121467 | Russia |
| Moscow City Oncology Hospital # 62 chemotherapy department | Moscow Region | 143423 | Russia |
| Omsk Clinical Oncologic Dispensary Chemotherapy | Omsk | 644046 | Russia |
| Scientific Centre for Specialized Medical Care (oncological) Chemotherapy | Saint Petersburg | 115478 | Russia |
| National Medical Research Center of Oncology N.N. Petrova | Saint Petersburg | 197758 | Russia |
| Saint Petersburg City Oncology Clilnic | Saint Petersburg | 198255 | Russia |
| Multidisciplinary clinic "Reaviz | Samara | 443011 | Russia |
| Oncology dispensary No.2 Oncology department | Sochi | 354057 | Russia |
| SBIH of YR "Clinical oncology hospital chemotherapy department" | Yaroslavl | 150054 | Russia |
| "H. Valle de Hebrón Servicio de Oncología - (VHIR)" | Barcelona | 08035 | Spain |
| "Hospital de la Santa Creu I Sant Pau Oncología Medica" | Barcelona | 08041 | Spain |
| "Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica" | Córdoba | 14004 | Spain |
| "INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica" | L'Hospitalet de Llobregat | 08908 | Spain |
| "Hospital Universitario Ramón y Cajal Servicio de Oncologia Médica" | Madrid | 28034 | Spain |
| "HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica" | Madrid | 28041 | Spain |
| "Hospital Universitario Marqués de Valdecilla oncología medica" | Santander | 39008 | Spain |
| H.VIRGEN DEL ROCIO Servicio de Oncología Médica | Seville | 41013 | Spain |
| H. GENERAL DE VALENCIA Servicio de Oncología Médica | Valencia | 46014 | Spain |
| Hospital Universitario Miguel Servet Edif. de maternidad planta 8. Servicio de Oncología Médical | Zaragoza | 50009 | Spain |
| Kyiv City Clinical Oncological Centre | Kiev | Ukrain | 03115 | Ukraine |
| Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre | Cherkassy | 18009 | Ukraine |
| "MI ""Dnipropetrovsk City Multi-field Clinical Hospital #4"" Department of Oncology" | Dnipro | 49102 | Ukraine |
| LLC Ukrainian Center of Tomotherapy "Tomoclinic", Chemoteraphy Department | Kropyvnytskyi | 25011 | Ukraine |
| National Institute of Cancer Abdominal Oncology Department | Kyiv | 03022 | Ukraine |
| Medical Center n.a. Acad. Spizhenko "Syber Clinic Spizhenko"" Department of Oncology | Kyiv | 08112 | Ukraine |
| "Clinical and diagnostic Centre of Medics-rey Inter. Group LLC Hospital of Israeli Oncology "LISOD" | Kyiv | 08720 | Ukraine |
| Podillia Regional Oncology Centre Chemotherapy Department | Vinnitsya | 21029 | Ukraine |
| Derived |
| Prager GW, Taieb J, Fakih M, Ciardiello F, Van Cutsem E, Elez E, Wyrwicz L, Stroyakovskiy D, Liposits G, Bondarenko I, Modest DP, Amellal N, Tabernero J; SUNLIGHT Investigators. Plain language summary of SUNLIGHT: trifluridine/tipiracil and bevacizumab for refractory metastatic colorectal cancer. Future Oncol. 2024;20(36):2823-2832. doi: 10.1080/14796694.2024.2366100. Epub 2024 Jul 2. |
| FG001 | Trifluridine/Tipiracil | Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS): all participants to whom a therapeutic unit was randomly assigned using Interactive Web Response System (IWRS). Participants were analyzed in the arm they were assigned by randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | Trifluridine/Tipiracil + Bevacizumab | Participants were administered 35 mg/m²/dose FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab 5 mg/kg, IV infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks. |
| BG001 | Trifluridine/Tipiracil | Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks. |
| 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 | Median | Full Range | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival (OS) | Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. | Analysis was performed on FAS population. | Posted | Median | 95% Confidence Interval | months | From date of randomization to the death due to any cause or cut-off date, whichever comes first (maximum duration: up to 20 months) |
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| Primary | Survival Probability at 6 Months | Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 6 months was reported. | Analysis was performed on FAS population. | Posted | Number | 95% Confidence Interval | probability of participants | From date of randomization until 6 months post treatment |
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| Primary | Survival Probability at 12 Months | Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 12 months was reported. | Analysis was performed on FAS population. | Posted | Number | 95% Confidence Interval | probability of participants | From date of randomization until 12 months post treatment |
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| Primary | Survival Probability at 18 Months | Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 18 months was reported. | Analysis was performed on FAS population. | Posted | Number | 95% Confidence Interval | probability of participants | From date of randomization until 18 months post treatment |
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| Secondary | Progression Free Survival (PFS) | PFS was defined as the time elapsed between the date of randomisation and the date of radiological tumour progression as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by investigator, or death (from any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. | Analysis was performed on FAS population. | Posted | Median | 95% Confidence Interval | months | From randomization to the date of radiological tumour progression or death due to any cause or data cut-off date whichever comes first (i.e., up to 20 months) |
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| Secondary | Probability of Participants With Progression Free Survival at 3, 6, 9 and 12 Months | PFS was defined as the time elapsed between the date of randomisation and the date of radiological tumour progression as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by investigator, or death (from any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. In this outcome measure, data of PFS at 3 months was reported. | Analysis was performed on FAS population. | Posted | Number | 95% Confidence Interval | probability of participants | From randomization until 3, 6, 9, and 12 months post treatment |
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| Secondary | Overall Response Rate (ORR) | Objective response was defined as percentage of participants who achieved complete response (CR) or partial response (PR) according to the RECIST version 1.1 and using investigator's tumour assessment. As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. | Analysis was performed on FAS population. | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of randomization to the date of documentation of progression or death due to any cause or data cut-off, whichever occurred first (i.e., up to 20 months) |
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| Secondary | Percentage of Participants With Disease Control | Disease control is defined as percentage of participants who achieved CR or PR, or stable disease (SD) as per RECIST 1.1 and using investigator's tumour assessment from the date of randomization to until disease progression or death due to any cause. As per RECIST 1.1, CR: disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. | Analysis was performed on FAS population. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to the date of first documented tumor progression, death due to any cause or data cut-off date whichever comes first (i.e., up to 20 months) |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs) | An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (time from the first dose of study treatment up to 30 days after the last dose of study treatment). TEAEs included both SAEs and non-SAEs. | Analysis was performed on safety set which included all participants who had taken at least one dose of investigational medicinal products and were analyzed according to the treatment they actually received. | Posted | Count of Participants | Participants | From baseline (Cycle 1 Day 1) up to 30 days after the last dose of study drug (i.e., up to 30.7 months) |
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| Secondary | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30): Time to Definitive Deterioration of >=10 Points in Sub-scale Scores - Kaplan-Meier Analysis | EORTC QLQ-C30: 30 item questionnaires with 5 multi-item functional subscales (physical, role, cognitive, emotional, social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), global health/quality of life (QOL) subscale and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation and financial impact of cancer). It employed twenty-eight 4-point Likert scales with responses from "not at all" to "very much" and GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional & GHS/QoL = higher level of functioning, & higher score for symptoms scales = higher symptom burden. Time to definitive >=10 points deterioration: time from date of randomization to first deterioration in QoL score >=10 points compared to baseline with no later improvement or death due to any cause. Kaplan-Meier method was used. | Analysis was performed on FAS population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. | Posted | Median | 95% Confidence Interval | months | Date of randomization to first deterioration in QoL score >=10 points or death due to any cause, which ever occurred first (i.e., up to 20 months) |
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| Secondary | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30): Time to Definitive Deterioration of >=10 Points in the Global Health Status Score - Kaplan-Meier Analysis | EORTC QLQ-C30: 30 item questionnaires composed of 5 multi-item functional subscales (physical, role, cognitive, emotional, social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), global health/QOL subscale and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation and financial impact of cancer). It employed twenty-eight 4-point Likert scales with responses from "not at all" to "very much" and GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional & GHS/QoL = higher level of functioning, & higher score for symptoms scales = higher symptom burden. Time to definitive >=10 points deterioration: time from date of randomization to the first deterioration in QoL score >=10 points compared to baseline with no later improvement or death due to any cause. Kaplan-Meier method was used. | Analysis was performed on FAS population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Date of randomization to first deterioration in QoL score >=10 points or death due to any cause, which ever occurred first (i.e., up to 20 months) |
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| Secondary | Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints | The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health utility and consist in 2 sections a descriptive system comprising 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and Visual Analog Scale (VAS). Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state. | Analysis was performed on FAS population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11, Cycle 12, Cycle 13 and Cycle 14 |
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| Secondary | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints | The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health utility and consist of 2 sections; descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a VAS. The VAS records the respondent's self-rated health on a 20 centimeter (cm) vertical VAS; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). This information can be used as a quantitative measure of health as judged by the individual respondents. | Analysis was performed on FAS population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11, Cycle 12, Cycle 13 and Cycle 14 |
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Serious AEs and Other AEs: From baseline (Cycle 1 Day 1) up to 30 days after the last dose of study drug (i.e., up to 30.7 months); All-cause mortality: from baseline (Cycle 1 Day 1) up to end of the study (i.e., up to 33.6 months)
Analysis was performed on safety set population which included all participants who took at least one dose of FTD/TPI and were analyzed according to the treatment actually received. Reported serious AEs and other AEs were treatment-emergent AEs that developed, worsened or became serious from baseline (Cycle 1 Day 1) up to 30 days after the last dose of the study drug.
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 | Trifluridine/Tipiracil + Bevacizumab | Participants were administered 35 mg/m²/dose FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab 5 mg/kg, IV infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks. | 208 | 246 | 66 | 246 | 241 | 246 |
| EG001 | Trifluridine/Tipiracil | Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks. | 224 | 246 | 79 | 246 | 241 | 246 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
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| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
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| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
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| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
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| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
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| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
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| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
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| Metastases to ovary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (25.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (25.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (25.0) | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA (25.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (25.0) | Systematic Assessment |
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| Death | General disorders | MedDRA (25.0) | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA (25.0) | Systematic Assessment |
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| Malaise | General disorders | MedDRA (25.0) | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA (25.0) | Systematic Assessment |
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| Prostatitis | Reproductive system and breast disorders | MedDRA (25.0) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Dyspnoea at rest | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
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| Psychomotor retardation | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Gastrointestinal stoma output decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Stoma site haemorrhage | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Balance disorder | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
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| Haemorrhagic stroke | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
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| Diplegia | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
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| Hepatic encephalopathy | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Abdominal lymphadenopathy | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Glaucoma | Eye disorders | MedDRA (25.0) | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Subileus | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Abdominal hernia | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Anal fistula | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Abdominal tenderness | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Gastrointestinal fistula | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Intestinal perforation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Large intestinal stenosis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Jaundice cholestatic | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
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| Jaundice | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
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| Bile duct stenosis | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
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| Biliary dilatation | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
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| Hepatic failure | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
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| Cholestasis | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
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| Hepatomegaly | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
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| Pyelocaliectasis | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
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| Prerenal failure | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Urinary tract infection pseudomonal | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Vascular device infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Abdominal sepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Intestinal sepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Paracancerous pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Peritonitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Pneumonia streptococcal | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Postoperative abscess | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Staphylococcal sepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Urinary tract infection bacterial | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Bacterial pyelonephritis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Abdominal infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Bacterial prostatitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Klebsiella sepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Pelvic abscess | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
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| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
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| Cachexia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Gastrointestinal ischaemia | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Small intestinal stenosis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Phimosis | Congenital, familial and genetic disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Duodenal stenosis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophil count decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taiho | Taiho Oncology, Inc. | +1-844-878-2446 | medicalinformation@taihooncology.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 2, 2022 | Oct 16, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613803 | trifluridine tipiracil drug combination |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| From 65-84 years |
|
| 85 years and over |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 |
| Trifluridine/Tipiracil |
Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks. |
|
|
| OG001 | Trifluridine/Tipiracil | Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks. |
|
|
| OG001 | Trifluridine/Tipiracil | Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks. |
|
|
| OG001 | Trifluridine/Tipiracil | Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks. |
|
|
| OG001 | Trifluridine/Tipiracil | Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks. |
|
|
| OG001 |
| Trifluridine/Tipiracil |
Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks. |
|
|