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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005975-17 | EudraCT Number |
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This two-part, multicenter study will evaluate the safety, tolerability and efficacy of pertuzumab in combination with standard chemotherapy in women with recurrent platinum-resistant epithelial ovarian cancer. In the non-randomized Part 1 safety run-in, participants will receive pertuzumab plus either topotecan or paclitaxel. In the randomized, double-blind Part 2 of the study, participants will receive either pertuzumab or placebo in combination with chemotherapy (topotecan, paclitaxel, or gemcitabine).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Pertuzumab + Topotecan | Experimental | Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. |
|
| Part 1: Pertuzumab + Paclitaxel | Experimental | Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. |
|
| Part 2: Pertuzumab+Chemotherapy | Experimental | Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion. |
|
| Part 2: Placebo+Chemotherapy | Placebo Comparator | Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine (Chemotherapy) | Drug | Participants administered gemcitabine at a dosage of 1000 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Days 1 and 8 every 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Percentage of Participants With Adverse Events (AEs) | An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment) |
| Part 2: Progression Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Including Malignant Bowel Obstruction (MBO) | PFS (IRC-Assessed) was defined as the time from randomization into Part 2 of the trial until progressive disease (PD), MBO or death from any cause, whichever occurred first per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. | Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1- Objective Response Rate (ORR) | ORR was defined as the number of participants with best overall response (BOR) of complete response (CR) or partial response (PR) recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie | Innsbruck | 6020 | Austria | |||
| Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31420414 | Derived | Lorusso D, Hilpert F, Gonzalez Martin A, Rau J, Ottevanger P, Greimel E, Luck HJ, Selle F, Colombo N, Kroep JR, Mirza MR, Berger R, Pardo B, Grischke EM, Berton-Rigaud D, Martinez-Garcia J, Vergote I, Redondo A, Cardona A, Bastiere-Truchot L, du Bois A, Kurzeder C; PENELOPE trial investigators. Patient-reported outcomes and final overall survival results from the randomized phase 3 PENELOPE trial evaluating pertuzumab in low tumor human epidermal growth factor receptor 3 (HER3) mRNA-expressing platinum-resistant ovarian cancer. Int J Gynecol Cancer. 2019 Sep;29(7):1141-1147. doi: 10.1136/ijgc-2019-000370. Epub 2019 Aug 15. |
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A total of 208 participants were entered into the study, 52 participants in Part 1, and 156 participants in Part 2 of the study. Of these, 203 received treatment with pertuzumab or pertuzumab-placebo (50 participants in Part 1 and 153 participants in Part 2).
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Pertuzumab + Topotecan | Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. |
| FG001 | Part 1: Pertuzumab + Paclitaxel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1: Safety Run in Phase |
|
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| Paclitaxel (Chemotherapy) | Drug | Participants administered paclitaxel at a dosage of 80 mg/m^2 as 1 hour IV infusion on Days 1, 8 and 15 every 3 weeks. |
|
| Pertuzumab | Drug | Participants administered pertuzumab 840 milligrams (mg) IV infusion on Day 1 of the first treatment cycle as a loading dose, followed by 420 mg on Day 1 of each subsequent 3 weekly cycle. |
|
| Placebo | Drug | Participants administered pertuzumab matching placebo IV infusion on Day 1 of each 3 weekly cycle. |
|
| Topotecan (Chemotherapy) | Drug | Participants administered topotecan at a dosage of 1.25 mg/m^2 as a 30 minute IV infusion daily on Days 1 to 5 every 3 weeks. |
|
| Approximately 28 months (assessed at baseline and every 9 weeks from randomization until disease progression) |
| Part 2- Objective Response Rate (ORR) | ORR was defined as the number of participants with BOR of CR or PR recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression) |
| Part 1: PFS Assessed by the Investigator | PFS as assessed by Investigator was defined as the time from first dose of pertuzumab or chemotherapy in Part 1 of the trial, until disease progression according to RECIST version 1.1, symptomatic deterioration or death from any cause, whichever occurs first. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants were censored at the last tumor assessment. Participants who have no tumor assessments after baseline and who were still alive will be censored at 1 day. | Approximately 28 months (assessed at screening and every 9 weeks from randomization until disease progression) |
| Part 2: Progression-free Survival (PFS) Assessed by the Investigator | PFS (Investigator-assessed) is defined as the time from randomization, until disease progression according to RECIST v1.1 including death or MBO, whichever occurs first. Censoring is based on the last tumor assessment. If no tumor assessment post baseline, then censoring is at day 1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. | Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression) |
| Part 2: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (QLQ) of Core 30 (C30) Score | EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning. For symptom scores, a higher score represents a more severe level of symptoms. For the global health status scores, a higher score represents a better quality of life. | Baseline (assessed at baseline and every 9 weeks from randomization until disease progression) |
| Part 2: Percentage of Participants With Adverse Events (AEs) | An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment) |
| Part 2: Overall Survival | Overall survival was defined as the time from randomization into Part 2 of the trial until death from any cause | Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression) |
| Vienna |
| 1090 |
| Austria |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Herlev Hospital; Onkologisk afdeling | Herlev | 2730 | Denmark |
| Rigshospitalet, Onkologisk Klinik | København Ø | 2100 | Denmark |
| Institut Bergonie; Oncologie | Bordeaux | 33076 | France |
| Centre Francois Baclesse; Oncologie | Caen | 14076 | France |
| Centre Georges Francois Leclerc; Oncologie 3 | Dijon | 21079 | France |
| CRLCC Val dAurelle Paul Lam | Montpellier | 34298 | France |
| Hopital Tenon; Oncologie Radiotherapie | Paris | 75970 | France |
| Ch Lyon Sud; Chir Onc Gyne Sct Jules Courmont | Pierre-Bénite | 69310 | France |
| Clinique Armoricaine Radiologie; Hopital de Jour | Plérin | 22190 | France |
| Ico Rene Gauducheau; Oncologie | Saint-Herblain | 44805 | France |
| Centre Alexis Vautrin; Oncologie Medicale | Vandœuvre-lès-Nancy | 54511 | France |
| Institut Gustave Roussy; Oncologie Medicale | Villejuif | 94800 | France |
| St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe | Cologne | 50935 | Germany |
| Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe | Dresden | 01307 | Germany |
| Evangelischen Krankenhauses Düsseldorf; Frauenklinik | Düsseldorf | 40217 | Germany |
| Universitätsklinikum Essen; Zentrum Für Frauenheilkunde | Essen | 45122 | Germany |
| Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie | Essen | 45136 | Germany |
| Universitätsklinikum Freiburg; Frauenklinik | Freiburg im Breisgau | 79106 | Germany |
| Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum | Greifswald | 17475 | Germany |
| Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie | Hamburg | 20246 | Germany |
| Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding | Hanover | 30177 | Germany |
| Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg | Heidelberg | 69120 | Germany |
| UNI-Klinikum Campus Kiel Klinik f.Gynäkologie u.Geburtshilfe | Kiel | 24105 | Germany |
| Klinikum Konstanz, Frauenklinik | Konstanz | 78464 | Germany |
| Klinikum rechts der Isar der TU München; Frauenklinik & Poliklinik | München | 81675 | Germany |
| Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe | Offenbach | 63069 | Germany |
| Hämatologisch/Onkologische Praxis Dr. Herbrick - Zipp/Prof. Dr. Decker, Studienzentrum | Ravensburg | 88212 | Germany |
| Universitätsfrauen- und Poliklinik am Klinikum Suedstadt | Rostock | 18059 | Germany |
| Universitätsklinik Tübingen; Frauenklinik | Tübingen | 72076 | Germany |
| Universitätsklinikum Ulm Am Michelsberg; Frauenklinik | Ulm | 89075 | Germany |
| HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie | Wiesbaden | 65199 | Germany |
| Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica | Naples | Campania | 80131 | Italy |
| Istituto Regina Elena; Oncologia Medica A | Rome | Lazio | 00168 | Italy |
| Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica | Genoa | Liguria | 16128 | Italy |
| A.O.Spedali Civili; Ostetricia e Ginecologia | Brescia | Lombardy | 25123 | Italy |
| Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica | Milan | Lombardy | 20133 | Italy |
| Istituto Europeo Di Oncologia | Milan | Lombardy | 20141 | Italy |
| A.O.U Pisana; Dipartimento di Ginecologia Oncologica | Pisa | Tuscany | 56126 | Italy |
| Antoni van Leeuwenhoek Ziekenhuis | Amsterdam | 1066 CX | Netherlands |
| Academ Ziekenhuis Groningen; Medical Oncology | Groningen | 9713 GZ | Netherlands |
| Academisch Ziekenhuis Leiden; Clinical Oncology | Leiden | 2333 ZA | Netherlands |
| UMC St Radboud | Nijmegen | 6525 GA | Netherlands |
| The Norvegian Radium Hospital Montebello; Dept of Oncology | Oslo | 0379 | Norway |
| Hospital Son Llatzer; Servicio de Oncologia | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | Barcelona | 08035 | Spain |
| Hospital Clínic i Provincial; Servicio de Hematología y Oncología | Barcelona | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia | Barcelona | Barcelona | 08041 | Spain |
| Hospital Duran i Reynals; Oncologia | Barcelona | Barcelona | 08907 | Spain |
| Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia | Barcelona | Barcelona | 08916 | Spain |
| Corporacio Sanitaria Parc Tauli; Servicio de Oncologia | Sabadell | Barcelona | 08208 | Spain |
| Hospital Universitario Reina Sofia; Servicio de Oncologia | Córdoba | Cordoba | 14004 | Spain |
| Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia | Girona | Girona | 17007 | Spain |
| Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia | Lleida | Lerida | 25198 | Spain |
| Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | Madrid | 28007 | Spain |
| Centro Oncologico MD Anderson Internacional; Servicio de Oncologia | Madrid | Madrid | 28033 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | Madrid | 28041 | Spain |
| Hospital Universitario La Paz; Servicio de Oncologia | Madrid | Madrid | 28046 | Spain |
| Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica | Madrid | Madrid | 28050 | Spain |
| Hospital Regional Universitario Carlos Haya; Servicio de Oncologia | Málaga | Malaga | 29010 | Spain |
| Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia | Murcia | Murcia | 30120 | Spain |
| Instituto Valenciano Oncologia; Oncologia Medica | Valencia | Valencia | 46009 | Spain |
| Hospital Universitario la Fe; Servicio de Oncologia | Valencia | Valencia | 46026 | Spain |
| Hospital Universitario Miguel Servet; Servicio Oncologia | Zaragoza | Zaragoza | 50009 | Spain |
| Universitetssjukhuset; Onkologkliniken | Linköping | 58185 | Sweden |
| Skånes University Hospital, Skånes Department of Onclology | Lund | 22185 | Sweden |
Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. |
| FG002 | Part 2: Pertuzumab+Chemotherapy | Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion. |
| FG003 | Part 2: Placebo+Chemotherapy | Participants received pertuzumab-matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion. |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Part 2: Randomized Phase |
|
|
Part 1: all participants enrolled and treated in Part 1 of the study ('as treated' analysis) and Part 2: intent-to-treat (ITT) population was defined as all randomized participants in the group to which they were randomly assigned ('as randomized' analysis).
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Pertuzumab + Topotecan | Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. |
| BG001 | Part 1: Pertuzumab + Paclitaxel | Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. |
| BG002 | Part 2: Pertuzumab+Chemotherapy | Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion. |
| BG003 | Part 2: Placebo+Chemotherapy | Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion. |
| BG004 | 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, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1: Percentage of Participants With Adverse Events (AEs) | An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | All Treated population included all participants enrolled and treated in Part 1 of the study ('as treated' analysis) and who had received at least 1 dose of pertuzumab or chemotherapy. | Posted | Number | percentage of participants | Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment) |
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| Primary | Part 2: Progression Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Including Malignant Bowel Obstruction (MBO) | PFS (IRC-Assessed) was defined as the time from randomization into Part 2 of the trial until progressive disease (PD), MBO or death from any cause, whichever occurred first per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. | ITT Population was defined as all randomized participants in the group to which they were randomly assigned ('as randomized' analysis). | Posted | Median | 95% Confidence Interval | months | Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression) |
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| Secondary | Part 1- Objective Response Rate (ORR) | ORR was defined as the number of participants with best overall response (BOR) of complete response (CR) or partial response (PR) recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All Treated participants with measurable disease at baseline. | Posted | Number | percentage of participants | Approximately 28 months (assessed at baseline and every 9 weeks from randomization until disease progression) |
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| Secondary | Part 2- Objective Response Rate (ORR) | ORR was defined as the number of participants with BOR of CR or PR recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | ITT population with measurable disease at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression) |
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| Secondary | Part 1: PFS Assessed by the Investigator | PFS as assessed by Investigator was defined as the time from first dose of pertuzumab or chemotherapy in Part 1 of the trial, until disease progression according to RECIST version 1.1, symptomatic deterioration or death from any cause, whichever occurs first. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants were censored at the last tumor assessment. Participants who have no tumor assessments after baseline and who were still alive will be censored at 1 day. | All Treated population included all participants enrolled and treated in Part 1 of the study ('as treated' analysis) and who had received at least 1 dose of pertuzumab or chemotherapy. | Posted | Median | 95% Confidence Interval | months | Approximately 28 months (assessed at screening and every 9 weeks from randomization until disease progression) |
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| Secondary | Part 2: Progression-free Survival (PFS) Assessed by the Investigator | PFS (Investigator-assessed) is defined as the time from randomization, until disease progression according to RECIST v1.1 including death or MBO, whichever occurs first. Censoring is based on the last tumor assessment. If no tumor assessment post baseline, then censoring is at day 1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. | ITT Population included all randomized participants in the group to which they were randomly assigned ('as randomized' analysis) | Posted | Median | 95% Confidence Interval | months | Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression) |
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| Secondary | Part 2: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (QLQ) of Core 30 (C30) Score | EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning. For symptom scores, a higher score represents a more severe level of symptoms. For the global health status scores, a higher score represents a better quality of life. | ITT population included all randomized participants in the group to which they were randomly assigned ('as randomized' analysis). | Posted | Mean | Standard Deviation | units on a scale | Baseline (assessed at baseline and every 9 weeks from randomization until disease progression) |
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| Secondary | Part 2: Percentage of Participants With Adverse Events (AEs) | An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Safety population included all participants who had received at least 1 dose of pertuzumab, pertuzumab-placebo, or chemotherapy. | Posted | Number | percentage of participants | Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment) |
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| Secondary | Part 2: Overall Survival | Overall survival was defined as the time from randomization into Part 2 of the trial until death from any cause | ITT Population included all randomized participants in the group to which they were randomly assigned ('as randomized' analysis) | Posted | Median | 95% Confidence Interval | months | Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression) |
|
|
Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment)
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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 | Part 1: Pertuzumab + Topotecan | Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. | 9 | 22 | 21 | 22 | ||
| EG001 | Part 1: Pertuzumab + Paclitaxel | Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. | 11 | 28 | 27 | 28 | ||
| EG002 | Part 2: Pertuzumab+Chemotherapy | Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion. | 29 | 77 | 72 | 77 | ||
| EG003 | Part 2: Placebo+Chemotherapy | Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion. | 33 | 76 | 75 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal Infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Bone Marrow Failure | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anal Fissure | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Duodenal Fistula | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Performance Status Decreased | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Infective Myositis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Kidney Infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Meningitis Pneumococcal | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Contrast Media Reaction | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
| |
| Cerebral Ischaemia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Urinary Tract Disorder | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Urinary Tract Obstruction | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vaginal Fistula | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Eczema Asteatotic | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Not yet coded | General disorders | MedDRA (17.1) | Systematic Assessment | This adverse event was not coded at the time of the primary analysis. The preferred term will be reported when available at the final analysis. |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nail Disorder | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pain Of Skin | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Nail Infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Ejection Fraction Decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Peripheral Motor Neuropathy | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D004358 | Drug Therapy |
| D017239 | Paclitaxel |
| C485206 | pertuzumab |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013812 | Therapeutics |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
Not provided
Not provided
| Lost to Follow-up |
|
| Death |
|
| Alive at data-cut |
|
| Participant noncompliance |
|
| Greater than (>)65 years |
|
| Male |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|