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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000336-42 | EudraCT Number |
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A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in Patients with Stage III Unresectable Non-Small Cell Lung Cancer.
A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDI4736 | Experimental | MEDI4736 (intravenous infusion) |
|
| PLACEBO | Placebo Comparator | Placebo (matching placebo for intravenous infusion) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI4736 | Drug | MEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | PFS was defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression). Progression was defined using RECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS was calculated using the Kaplan-Meier technique. | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years. |
| Overall Survival | OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique. | From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1 | ORR was defined as the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR. | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phil Dennis, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chandler | Arizona | 85224 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42398520 | Derived | Brunetti L, Santo V, Pinato DJ, Citarella F, Orlando S, Acker F, Colella V, Ricciuti B, Naidoo J, Nassar A, Wakelee HA, Takada K, Naqash AR, Garassino MC, Greco C, Ramella S, Pantano F, Tonini G, Vincenzi B, Arlunno B, Remon J, Parisi C, Planchard D, Besse B, Desilets A, Routy B, Elkrief A, Barlesi F, Derosa L, Cortellini A. Differential impact of proton pump inhibitors and antibiotics on immunotherapy efficacy after chemoradiotherapy in locally advanced non-small-cell lung cancer: a post-hoc analysis of the PACIFIC trial. Lancet Oncol. 2026 Jul 3:S1470-2045(26)00191-9. doi: 10.1016/S1470-2045(26)00191-9. Online ahead of print. | |
| 36841540 |
| Label | URL |
|---|---|
| CSR redacted synopsis | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Eligible patients with locally advanced, unresectable Stage III non-small cell lung cancer were randomized in a 2:1 ratio to receive either durvalumab (MEDI4736) 10 milligrams (mg) / kilogram (kg) every 2 weeks (Q2W) or placebo.
Patients were randomized between 09 May 2014 and 22 Apr 2016 in 235 study centers across 26 countries. Data cut-off (DCO) date for analysis of progression-free survival (PFS) and PFS rates at 12 and 18 months: 13 Feb 2017; DCO date for analysis of overall survival (OS) and all other secondary outcome measures: 22 Mar 2018; DCO date for completion of long-term survival: 11 Jan 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Durvalumab (MEDI4736) | Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 4, 2019 | Sep 20, 2021 |
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| PLACEBO | Other | PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo). |
|
| Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1 | DoR was defined as the time from date for first documented response of CR or PR until the first documented response of progression per RECIST 1.1 or death in the absence of progression. DoR was calculated using the Kaplan-Meier technique. | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. |
| Proportion of Patients Alive and Progression Free at 12 Months From (APF12) Based on BICR Assessments According to RECIST 1.1 | APF12 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 12 months after randomization per Kaplan-Meier estimate of PFS at 12 months. | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years. |
| Proportion of Patients Alive and Progression Free at 18 Months From (APF18) Based on BICR Assessments According to RECIST 1.1 | APF18 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 18 months after randomization per the Kaplan-Meier estimate of PFS at 18 months. | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years. |
| Time to Death or Distant Metastasis (TTDM) Based on BICR Assessments According to RECIST 1.1 | TTDM was defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis was defined as any new lesion that was outside of the radiation field according to RECIST 1.1 or proven by biopsy. TTDM was calculated using the Kaplan-Meier technique. | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. |
| Percentage of Patients Alive at 24 Months (OS24) | OS24 was defined as the percentage of patients who were alive at 24 months after randomization per the Kaplan-Meier estimate of OS at 24 months. | From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. |
| Time to Second Progression or Death (PFS2) | PFS2 was defined as the time from randomization to the time of the second progression or death. The date of second progression was recorded by the investigator and defined according to local standard clinical practice, and could have involved any of the following: objective radiological, symptomatic progression, or death. RECIST assessments were not collected for assessment of PFS2. PFS2 was calculated using the Kaplan-Meier technique. | Following confirmed progression, patients were assessed every ~12 weeks until second disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. |
| Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL), Assessed Using European Organization for Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Global health status/HRQoL was assessed using the EORTC QLQ-C30 global QoL scale which includes 2 items from the QLQ-C30: "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall QoL during the past week?" (Item 30). Scores from 0 to 100 were derived for each item with higher scores indicating a better health status. Time to deterioration for global health status/HRQoL was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in global health status/HRQoL from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful deterioration. Time to deterioration was calculated using the Kaplan-Meier technique. | At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. |
| Time to Deterioration of Primary Patient-Reported Outcome (PRO) Symptoms, Assessed Using European Organization for Research and Treatment of Cancer QoL Lung Cancer Module (EORTC QLQ-LC13) | The EORTC QLQ-LC13 is a lung cancer specific module from the EORTC comprising 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, chest pain, arm/shoulder pain, and other pain), treatment related side-effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores from 0 to 100 were derived for each symptom item with higher scores representing greater symptom severity. Time to symptom deterioration was defined as time from randomization until the date of first clinically meaningful symptom deterioration (an increase in the score from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful symptom deterioration. Results are presented for time to deterioration in the following PRO endpoints identified as primary for EORTC QLQ-LC13: dyspnea, cough, hemoptysis and chest pain. Time to deterioration was calculated using the Kaplan-Meier technique. | At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. |
| Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations | To evaluate PK, blood samples were collected pre-dose and post-dose and trough and peak serum concentrations of durvalumab, respectively, were determined. Pre-dose samples were taken within 60 minutes before infusion and post-dose samples were taken within 10 minutes after the end of infusion. | Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48, and post-dose on Day 1 (Week 0) and Week 24. Analysis performed at 22 Mar 2018 DCO. |
| Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab | ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted by ≥4-fold following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Confirmed ADA positive samples were subsequently tested in a neutralizing antibody assay. | Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48. Analysis performed at 22 Mar 2018 DCO. |
| Goodyear |
| Arizona |
| 85338 |
| United States |
| Research Site | Jonesboro | Arkansas | 72405 | United States |
| Research Site | Springdale | Arkansas | 72762 | United States |
| Research Site | Fullerton | California | 92835 | United States |
| Research Site | Los Angeles | California | 90095 | United States |
| Research Site | Oxnard | California | 93030 | United States |
| Research Site | Sacramento | California | 95816 | United States |
| Research Site | San Diego | California | 92123 | United States |
| Research Site | Santa Rosa | California | 95403 | United States |
| Research Site | Norwich | Connecticut | 06360 | United States |
| Research Site | Washington D.C. | District of Columbia | 20007 | United States |
| Research Site | Fort Myers | Florida | 33901 | United States |
| Research Site | Jacksonville | Florida | 32207 | United States |
| Research Site | Miami Beach | Florida | 33140 | United States |
| Research Site | Orlando | Florida | 32804 | United States |
| Research Site | Port Saint Lucie | Florida | 34952 | United States |
| Research Site | St. Petersburg | Florida | 33705 | United States |
| Research Site | Tampa | Florida | 33612 | United States |
| Research Site | Atlanta | Georgia | 30318 | United States |
| Research Site | Atlanta | Georgia | 30322 | United States |
| Research Site | Fort Gordon | Georgia | 30905 | United States |
| Research Site | Lawrenceville | Georgia | 30046 | United States |
| Research Site | Marietta | Georgia | 30060 | United States |
| Research Site | Waterloo | Iowa | 50701 | United States |
| Research Site | Topeka | Kansas | 66606 | United States |
| Research Site | Hazard | Kentucky | 41701 | United States |
| Research Site | Baltimore | Maryland | 21287 | United States |
| Research Site | Rockville | Maryland | 20850 | United States |
| Research Site | Rosedale | Maryland | 21237 | United States |
| Research Site | Salisbury | Maryland | 21801 | United States |
| Research Site | Towson | Maryland | 21204 | United States |
| Research Site | Boston | Massachusetts | 02215 | United States |
| Research Site | Lansing | Michigan | 48910 | United States |
| Research Site | Minneapolis | Minnesota | 55426 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | Lincoln | Nebraska | 68510 | United States |
| Research Site | Hackensack | New Jersey | 07601 | United States |
| Research Site | Lake Success | New York | 11041 | United States |
| Research Site | The Bronx | New York | 10461 | United States |
| Research Site | Burlington | North Carolina | 27215 | United States |
| Research Site | Charlotte | North Carolina | 28204 | United States |
| Research Site | Pinehurst | North Carolina | 28374 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Blue Ash | Ohio | 45242 | United States |
| Research Site | Easley | South Carolina | 29640 | United States |
| Research Site | Chattanooga | Tennessee | 37404 | United States |
| Research Site | Nashville | Tennessee | 37203 | United States |
| Research Site | Nashville | Tennessee | 37232-8805 | United States |
| Research Site | Austin | Texas | 78731 | United States |
| Research Site | Dallas | Texas | 75231 | United States |
| Research Site | Dallas | Texas | 75246 | United States |
| Research Site | Fort Worth | Texas | 76104 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Tyler | Texas | 75702 | United States |
| Research Site | Salt Lake City | Utah | 84106 | United States |
| Research Site | Fairfax | Virginia | 22031 | United States |
| Research Site | Spokane | Washington | 99208 | United States |
| Research Site | Spokane | Washington | 99218 | United States |
| Research Site | Vancouver | Washington | 98684 | United States |
| Research Site | Bedford Park | 5042 | Australia |
| Research Site | Bendigo | 3550 | Australia |
| Research Site | Box Hill | 3128 | Australia |
| Research Site | Clayton | 3168 | Australia |
| Research Site | Heidelberg | 3084 | Australia |
| Research Site | Herston | 4029 | Australia |
| Research Site | Kogarah | 2217 | Australia |
| Research Site | Launceston | 7250 | Australia |
| Research Site | Nedlands | 6009 | Australia |
| Research Site | Port Macquarie | 2444 | Australia |
| Research Site | Randwick | 2031 | Australia |
| Research Site | Westmead | 2145 | Australia |
| Research Site | Woolloongabba | 4102 | Australia |
| Research Site | Aalst | 9300 | Belgium |
| Research Site | Gilly | 6060 | Belgium |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Libramont-Chevigny | 6800 | Belgium |
| Research Site | Liège | 4000 | Belgium |
| Research Site | Calgary | Alberta | T2N 4N2 | Canada |
| Research Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Research Site | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Research Site | Barrie | Ontario | L4M 6M2 | Canada |
| Research Site | London | Ontario | N6A 4L6 | Canada |
| Research Site | Newmarket | Ontario | L3Y 2P9 | Canada |
| Research Site | Oshawa | Ontario | L1G 2B9 | Canada |
| Research Site | Toronto | Ontario | M4N 3M5 | Canada |
| Research Site | Toronto | M5G 2M9 | Canada |
| Research Site | Santiago | 7500000 | Chile |
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| Research Site | Avignon | 84918 | France |
| Research Site | Bayonne | 64100 | France |
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| Research Site | Lille | 59037 | France |
| Research Site | Lyon | 69008 | France |
| Research Site | Marseille | 13915 | France |
| Research Site | Montpellier | 34295 | France |
| Research Site | Nantes | 44202 | France |
| Research Site | Nice | 06100 | France |
| Research Site | Pau | 6400 | France |
| Research Site | Rennes | 35033 | France |
| Research Site | Saint-Herblain | 44805 | France |
| Research Site | Toulouse | 31000 | France |
| Research Site | Villejuif | 94805 | France |
| Research Site | Berlin | 10967 | Germany |
| Research Site | Berlin | 12351 | Germany |
| Research Site | Esslingen am Neckar | 73730 | Germany |
| Research Site | Großhansdorf | 20927 | Germany |
| Research Site | Hamburg | 20251 | Germany |
| Research Site | Hamburg | 22081 | Germany |
| Research Site | Löwenstein | 74245 | Germany |
| Research Site | Recklinghausen | 45659 | Germany |
| Research Site | Regensburg | 93053 | Germany |
| Research Site | Villingen-Schwenningen | 78052 | Germany |
| Research Site | Athens | 11527 | Greece |
| Research Site | Heraklion | 71110 | Greece |
| Research Site | Pátrai | 26500 | Greece |
| Research Site | Thessaloniki | 54645 | Greece |
| Research Site | Thessaloniki | 57010 | Greece |
| Research Site | Budapest | 1083 | Hungary |
| Research Site | Budapest | 1121 | Hungary |
| Research Site | Gyula | 5703 | Hungary |
| Research Site | Miskolc | 3529 | Hungary |
| Research Site | Haifa | 31096 | Israel |
| Research Site | Jerusalem | 91120 | Israel |
| Research Site | Aviano | 33081 | Italy |
| Research Site | Catania | 95123 | Italy |
| Research Site | Cremona | 26100 | Italy |
| Research Site | Lecce | 73100 | Italy |
| Research Site | Milan | 20132 | Italy |
| Research Site | Milan | 20133 | Italy |
| Research Site | Naples | 80138 | Italy |
| Research Site | Pisa | 56126 | Italy |
| Research Site | Roma | 00144 | Italy |
| Research Site | Bunkyō City | 113-8431 | Japan |
| Research Site | Bunkyō City | 113-8603 | Japan |
| Research Site | Chūōku | 104-0045 | Japan |
| Research Site | Fukuoka | 812-8582 | Japan |
| Research Site | Habikino-shi | 583-8588 | Japan |
| Research Site | Hidaka-shi | 350-1298 | Japan |
| Research Site | Hirakata-shi | 573-1191 | Japan |
| Research Site | Hiroshima | 730-8518 | Japan |
| Research Site | Kanazawa | 920-8641 | Japan |
| Research Site | Kashiwa | 277-8577 | Japan |
| Research Site | Kitaadachi-gun | 362-0806 | Japan |
| Research Site | Kurume-shi | 830-0011 | Japan |
| Research Site | Matsuyama | 791-0280 | Japan |
| Research Site | Nagoya | 460-0001 | Japan |
| Research Site | Natori-shi | 981-1293 | Japan |
| Research Site | Okayama | 700-8558 | Japan |
| Research Site | Osaka | 541-8567 | Japan |
| Research Site | Ota-shi | 373-8550 | Japan |
| Research Site | Sagamihara-shi | 252-0375 | Japan |
| Research Site | Sakaishi | 591-8555 | Japan |
| Research Site | Sapporo | 003-0804 | Japan |
| Research Site | Sayama | 589-8511 | Japan |
| Research Site | Sendai | 980-0873 | Japan |
| Research Site | Shinjuku-ku | 162-8655 | Japan |
| Research Site | Sunto-gun | 411-8777 | Japan |
| Research Site | Takatsuki-shi | 569-8686 | Japan |
| Research Site | Ube-shi | 755-0241 | Japan |
| Research Site | Yokohama | 236-0051 | Japan |
| Research Site | Yokohama | 241-8515 | Japan |
| Research Site | Cuautitlán Izcalli | 54769 | Mexico |
| Research Site | Monterrey | 64460 | Mexico |
| Research Site | Oaxaca City | 68000 | Mexico |
| Research Site | Orizaba | 94300 | Mexico |
| Research Site | Amsterdam | 1066 CX | Netherlands |
| Research Site | Amsterdam | 1081 HV | Netherlands |
| Research Site | Breda | 4818 CK | Netherlands |
| Research Site | Eindhoven | 5623EJ | Netherlands |
| Research Site | Rotterdam | 3015 CE | Netherlands |
| Research Site | Tilburg | 5022 GC | Netherlands |
| Research Site | Lima | 41 | Peru |
| Research Site | Lima | LIMA 27 | Peru |
| Research Site | Gdansk | 80-952 | Poland |
| Research Site | Lublin | 20-362 | Poland |
| Research Site | Warsaw | 02-781 | Poland |
| Research Site | Singapore | 119074 | Singapore |
| Research Site | Singapore | 169610 | Singapore |
| Research Site | Singapore | 308433 | Singapore |
| Research Site | Bardejov | 08501 | Slovakia |
| Research Site | Košice | 041 91 | Slovakia |
| Research Site | Nové Zámky | 94002 | Slovakia |
| Research Site | Trnava | 91775 | Slovakia |
| Research Site | Cape Town | 7570 | South Africa |
| Research Site | Pretoria | 0181 | South Africa |
| Research Site | Vereeniging | 1930 | South Africa |
| Research Site | Busan | 49201 | South Korea |
| Research Site | Cheongju-si | 361-711 | South Korea |
| Research Site | Hwasun-gun | 58128 | South Korea |
| Research Site | Incheon | UNK | South Korea |
| Research Site | Seongnam-si | 13620 | South Korea |
| Research Site | Seoul | 02841 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 06351 | South Korea |
| Research Site | Suwon | 16247 | South Korea |
| Research Site | Alicante | 03010 | Spain |
| Research Site | Barcelona | 08003 | Spain |
| Research Site | Barcelona | 08041 | Spain |
| Research Site | Barcelona | 08908 | Spain |
| Research Site | Donostia / San Sebastian | 20014 | Spain |
| Research Site | Girona | 17007 | Spain |
| Research Site | Lleida | 25198 | Spain |
| Research Site | Madrid | 28005 | Spain |
| Research Site | Madrid | 28007 | Spain |
| Research Site | Madrid | 28041 | Spain |
| Research Site | Madrid | 28046 | Spain |
| Research Site | Madrid | 28050 | Spain |
| Research Site | Seville | 41009 | Spain |
| Research Site | Seville | 41013 | Spain |
| Research Site | Valencia | 46014 | Spain |
| Research Site | Valencia | 46026 | Spain |
| Research Site | Zaragoza | 50009 | Spain |
| Research Site | Taichung | 40447 | Taiwan |
| Research Site | Taipei | 110 | Taiwan |
| Research Site | Taipei | 112 | Taiwan |
| Research Site | Taipei | 23561 | Taiwan |
| Research Site | Taipei | Taiwan |
| Research Site | Bangkok | 10400 | Thailand |
| Research Site | Hat Yai | 90110 | Thailand |
| Research Site | Muang | 50200 | Thailand |
| Research Site | Adana | 01130 | Turkey (Türkiye) |
| Research Site | Ankara | 06490 | Turkey (Türkiye) |
| Research Site | Istanbul | 34030 | Turkey (Türkiye) |
| Research Site | Istanbul | 34844 | Turkey (Türkiye) |
| Research Site | Izmir | 35100 | Turkey (Türkiye) |
| Research Site | Konya | 42080 | Turkey (Türkiye) |
| Research Site | Malatya | 44280 | Turkey (Türkiye) |
| Research Site | Glasgow | G12 0YN | United Kingdom |
| Research Site | Manchester | M20 4BX | United Kingdom |
| Research Site | Truro | TR1 3LJ | United Kingdom |
| Research Site | Hanoi | 100000 | Vietnam |
| Research Site | Hanoi | 10000 | Vietnam |
| Research Site | Ho Chi Minh City | 700000 | Vietnam |
| Derived |
| Naidoo J, Antonia S, Wu YL, Cho BC, Thiyagarajah P, Mann H, Newton M, Faivre-Finn C. Brief Report: Durvalumab After Chemoradiotherapy in Unresectable Stage III EGFR-Mutant NSCLC: A Post Hoc Subgroup Analysis From PACIFIC. J Thorac Oncol. 2023 May;18(5):657-663. doi: 10.1016/j.jtho.2023.02.009. Epub 2023 Feb 24. |
| 35247871 | Derived | Senan S, Ozguroglu M, Daniel D, Villegas A, Vicente D, Murakami S, Hui R, Faivre-Finn C, Paz-Ares L, Wu YL, Mann H, Dennis PA, Antonia SJ. Outcomes with durvalumab after chemoradiotherapy in stage IIIA-N2 non-small-cell lung cancer: an exploratory analysis from the PACIFIC trial. ESMO Open. 2022 Apr;7(2):100410. doi: 10.1016/j.esmoop.2022.100410. Epub 2022 Mar 2. |
| 35245844 | Derived | Naidoo J, Vansteenkiste JF, Faivre-Finn C, Ozguroglu M, Murakami S, Hui R, Quantin X, Broadhurst H, Newton M, Thiyagarajah P, Antonia SJ. Characterizing immune-mediated adverse events with durvalumab in patients with unresectable stage III NSCLC: A post-hoc analysis of the PACIFIC trial. Lung Cancer. 2022 Apr;166:84-93. doi: 10.1016/j.lungcan.2022.02.003. Epub 2022 Feb 9. |
| 35108059 | Derived | Spigel DR, Faivre-Finn C, Gray JE, Vicente D, Planchard D, Paz-Ares L, Vansteenkiste JF, Garassino MC, Hui R, Quantin X, Rimner A, Wu YL, Ozguroglu M, Lee KH, Kato T, de Wit M, Kurata T, Reck M, Cho BC, Senan S, Naidoo J, Mann H, Newton M, Thiyagarajah P, Antonia SJ. Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Apr 20;40(12):1301-1311. doi: 10.1200/JCO.21.01308. Epub 2022 Feb 2. |
| 34484473 | Derived | Ouwens M, Darilay A, Zhang Y, Mukhopadhyay P, Mann H, Ryan J, Dennis PA. Assessing the Influence of Subsequent Immunotherapy on Overall Survival in Patients with Unresectable Stage III Non-Small Cell Lung Cancer from the PACIFIC Study. Curr Ther Res Clin Exp. 2021 Aug 12;95:100640. doi: 10.1016/j.curtheres.2021.100640. eCollection 2021. |
| 34294595 | Derived | Socinski MA, Ozguroglu M, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Gray JE, Park K, Vincent M, Mann H, Newton M, Dennis PA, Antonia SJ. Durvalumab After Concurrent Chemoradiotherapy in Elderly Patients With Unresectable Stage III Non-Small-Cell Lung Cancer (PACIFIC). Clin Lung Cancer. 2021 Nov;22(6):549-561. doi: 10.1016/j.cllc.2021.05.009. Epub 2021 Jun 12. |
| 33583206 | Derived | Garassino MC, Paz-Ares L, Hui R, Faivre-Finn C, Spira A, Planchard D, Ozguroglu M, Daniel D, Vicente D, Murakami S, Langer C, Senan S, Spigel D, Ryden A, Zhang Y, O'Brien C, Dennis PA, Antonia SJ. Patient-reported outcomes with durvalumab by PD-L1 expression and prior chemoradiotherapy-related variables in unresectable stage III non-small-cell lung cancer. Future Oncol. 2021 Apr;17(10):1165-1184. doi: 10.2217/fon-2020-1102. Epub 2021 Feb 15. |
| 33545688 | Derived | Mehra R, Yong C, Seal B, van Keep M, Raad A, Zhang Y. Cost-Effectiveness of Durvalumab After Chemoradiotherapy in Unresectable Stage III NSCLC: A US Healthcare Perspective. J Natl Compr Canc Netw. 2021 Feb 2;19(2):153-162. doi: 10.6004/jnccn.2020.7621. Print 2021 Feb. |
| 33476803 | Derived | Faivre-Finn C, Vicente D, Kurata T, Planchard D, Paz-Ares L, Vansteenkiste JF, Spigel DR, Garassino MC, Reck M, Senan S, Naidoo J, Rimner A, Wu YL, Gray JE, Ozguroglu M, Lee KH, Cho BC, Kato T, de Wit M, Newton M, Wang L, Thiyagarajah P, Antonia SJ. Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC-an Update From the PACIFIC Trial. J Thorac Oncol. 2021 May;16(5):860-867. doi: 10.1016/j.jtho.2020.12.015. Epub 2021 Jan 19. |
| 33285469 | Derived | Faivre-Finn C, Spigel DR, Senan S, Langer C, Perez BA, Ozguroglu M, Daniel D, Villegas A, Vicente D, Hui R, Murakami S, Paz-Ares L, Broadhurst H, Wadsworth C, Dennis PA, Antonia SJ. Impact of prior chemoradiotherapy-related variables on outcomes with durvalumab in unresectable Stage III NSCLC (PACIFIC). Lung Cancer. 2021 Jan;151:30-38. doi: 10.1016/j.lungcan.2020.11.024. Epub 2020 Nov 26. |
| 32209338 | Derived | Paz-Ares L, Spira A, Raben D, Planchard D, Cho BC, Ozguroglu M, Daniel D, Villegas A, Vicente D, Hui R, Murakami S, Spigel D, Senan S, Langer CJ, Perez BA, Boothman AM, Broadhurst H, Wadsworth C, Dennis PA, Antonia SJ, Faivre-Finn C. Outcomes with durvalumab by tumour PD-L1 expression in unresectable, stage III non-small-cell lung cancer in the PACIFIC trial. Ann Oncol. 2020 Jun;31(6):798-806. doi: 10.1016/j.annonc.2020.03.287. Epub 2020 Mar 21. |
| 31622733 | Derived | Gray JE, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, Cho BC, Planchard D, Paz-Ares L, Faivre-Finn C, Vansteenkiste JF, Spigel DR, Wadsworth C, Taboada M, Dennis PA, Ozguroglu M, Antonia SJ. Three-Year Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC-Update from PACIFIC. J Thorac Oncol. 2020 Feb;15(2):288-293. doi: 10.1016/j.jtho.2019.10.002. Epub 2019 Oct 14. |
| 31601496 | Derived | Hui R, Ozguroglu M, Villegas A, Daniel D, Vicente D, Murakami S, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Gray JE, Ryden A, Viviers L, Poole L, Zhang Y, Dennis PA, Antonia SJ. Patient-reported outcomes with durvalumab after chemoradiotherapy in stage III, unresectable non-small-cell lung cancer (PACIFIC): a randomised, controlled, phase 3 study. Lancet Oncol. 2019 Dec;20(12):1670-1680. doi: 10.1016/S1470-2045(19)30519-4. Epub 2019 Oct 7. |
| 30280658 | Derived | Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Ozguroglu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25. |
| 28885881 | Derived | Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8. |
Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.
| Full Analysis Set (FAS) |
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| Received Treatment |
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| Safety Analysis Set |
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| Completed 12 Months of Treatment |
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| COMPLETED | Ongoing study at final DCO (study complete) |
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| NOT COMPLETED |
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Baseline analysis was based on the FAS consisting of all randomized patients.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Durvalumab (MEDI4736) | Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months. |
| BG001 | Placebo | Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Smoking History | 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 | Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | PFS was defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression). Progression was defined using RECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS was calculated using the Kaplan-Meier technique. | FAS included all randomized patients, analyzed on an intent-to-treat (ITT) basis. | Posted | Median | 95% Confidence Interval | Months | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years. |
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| Primary | Overall Survival | OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique. | FAS included all randomized patients, analyzed on an ITT basis. | Posted | Median | 95% Confidence Interval | Months | From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. |
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| Secondary | Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1 | ORR was defined as the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR. | FAS (which included all randomized patients) with measureable disease at baseline, analyzed on an ITT basis. | Posted | Number | 95% Confidence Interval | Percentage of patients | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. |
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| Secondary | Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1 | DoR was defined as the time from date for first documented response of CR or PR until the first documented response of progression per RECIST 1.1 or death in the absence of progression. DoR was calculated using the Kaplan-Meier technique. | FAS included all randomized patients, analyzed on an ITT basis. Only patients with an objective response were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. |
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| Secondary | Proportion of Patients Alive and Progression Free at 12 Months From (APF12) Based on BICR Assessments According to RECIST 1.1 | APF12 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 12 months after randomization per Kaplan-Meier estimate of PFS at 12 months. | FAS included all randomized patients, analyzed on an ITT basis. | Posted | Number | 95% Confidence Interval | Percentage of patients | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years. |
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| Secondary | Proportion of Patients Alive and Progression Free at 18 Months From (APF18) Based on BICR Assessments According to RECIST 1.1 | APF18 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 18 months after randomization per the Kaplan-Meier estimate of PFS at 18 months. | FAS included all randomized patients, analyzed on an ITT basis. | Posted | Number | 95% Confidence Interval | Percentage of patients | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years. |
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| Secondary | Time to Death or Distant Metastasis (TTDM) Based on BICR Assessments According to RECIST 1.1 | TTDM was defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis was defined as any new lesion that was outside of the radiation field according to RECIST 1.1 or proven by biopsy. TTDM was calculated using the Kaplan-Meier technique. | FAS included all randomized patients, analyzed on an ITT basis. | Posted | Median | 95% Confidence Interval | Months | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. |
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| Secondary | Percentage of Patients Alive at 24 Months (OS24) | OS24 was defined as the percentage of patients who were alive at 24 months after randomization per the Kaplan-Meier estimate of OS at 24 months. | FAS included all randomized patients, analyzed on an ITT basis. | Posted | Number | 95% Confidence Interval | Percentage of patients | From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. |
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| Secondary | Time to Second Progression or Death (PFS2) | PFS2 was defined as the time from randomization to the time of the second progression or death. The date of second progression was recorded by the investigator and defined according to local standard clinical practice, and could have involved any of the following: objective radiological, symptomatic progression, or death. RECIST assessments were not collected for assessment of PFS2. PFS2 was calculated using the Kaplan-Meier technique. | FAS included all randomized patients, analyzed on an ITT basis. | Posted | Median | 95% Confidence Interval | Months | Following confirmed progression, patients were assessed every ~12 weeks until second disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. |
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| Secondary | Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL), Assessed Using European Organization for Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | Global health status/HRQoL was assessed using the EORTC QLQ-C30 global QoL scale which includes 2 items from the QLQ-C30: "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall QoL during the past week?" (Item 30). Scores from 0 to 100 were derived for each item with higher scores indicating a better health status. Time to deterioration for global health status/HRQoL was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in global health status/HRQoL from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful deterioration. Time to deterioration was calculated using the Kaplan-Meier technique. | FAS included all randomized patients, analyzed on an ITT basis. Only patients with baseline scores ≥ 10 were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. |
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| Secondary | Time to Deterioration of Primary Patient-Reported Outcome (PRO) Symptoms, Assessed Using European Organization for Research and Treatment of Cancer QoL Lung Cancer Module (EORTC QLQ-LC13) | The EORTC QLQ-LC13 is a lung cancer specific module from the EORTC comprising 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, chest pain, arm/shoulder pain, and other pain), treatment related side-effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores from 0 to 100 were derived for each symptom item with higher scores representing greater symptom severity. Time to symptom deterioration was defined as time from randomization until the date of first clinically meaningful symptom deterioration (an increase in the score from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful symptom deterioration. Results are presented for time to deterioration in the following PRO endpoints identified as primary for EORTC QLQ-LC13: dyspnea, cough, hemoptysis and chest pain. Time to deterioration was calculated using the Kaplan-Meier technique. | FAS included all randomized patients, analyzed on an ITT basis. Only patients with baseline scores ≤ 90 were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. |
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| Secondary | Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations | To evaluate PK, blood samples were collected pre-dose and post-dose and trough and peak serum concentrations of durvalumab, respectively, were determined. Pre-dose samples were taken within 60 minutes before infusion and post-dose samples were taken within 10 minutes after the end of infusion. | PK analysis set included all patients who received at least 1 dose of durvalumab per the protocol, for whom any post-dose data were available, and who did not violate or deviate from the protocol in ways that would significantly affect the PK analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48, and post-dose on Day 1 (Week 0) and Week 24. Analysis performed at 22 Mar 2018 DCO. |
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| Secondary | Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab | ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted by ≥4-fold following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Confirmed ADA positive samples were subsequently tested in a neutralizing antibody assay. | ADA evaluable population included patients who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA results. | Posted | Count of Participants | Participants | Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48. Analysis performed at 22 Mar 2018 DCO. |
|
Serious and Other (non-serious) treatment-emergent adverse event (TEAE) data collected during the 12-month treatment period. All-cause mortality (death due to any cause) collected for entire duration of the study. Assessed until 11 Jan 2021 DCO for completion of long-term survival; approximately 5 years from last patient enrolled.
TEAEs included events from first dose of study drug until the earlier of 90 days after last dose or date of first subsequent therapy. 473 and 236 patients in the durvalumab and placebo groups, respectively, received treatment but 2 patients randomized to placebo received 1 dose of durvalumab in error and are included in the durvalumab safety analysis set.
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 | Durvalumab (MEDI4736) | Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months. | 262 | 475 | 138 | 475 | 436 | 475 |
| EG001 | Placebo | Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months. | 154 | 234 | 54 | 234 | 212 | 234 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arteriospasm coronary | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Eosinophilic myocarditis | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia adenoviral | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Haemophilus infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| West Nile viral infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Myocardial necrosis marker increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Small intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute interstitial pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchopleural fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chest wall abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Endotoxaemia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia necrotising | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Post procedural fistula | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Brain natriuretic peptide increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Iron overload | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Giant cell tumour of tendon sheath | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Adjustment disorder with mixed anxiety and depressed mood | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Glomerulonephritis membranous | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal tubular acidosis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Calculus prostatic | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acquired tracheo-oesophageal fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
Results of interim PFS analysis are considered as final PFS analysis; results of interim OS analysis are considered as final OS analysis. Patients were followed up for long-term survival until approximately 5 years after last patient enrolled.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 22, 2017 | Sep 20, 2021 | SAP_005.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613593 | durvalumab |
Not provided
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| Native Hawaiian or Pacific Islander |
|
| American Indian or Alaska Native |
|
| Other |
|
| Missing |
|
| Ex-smoker |
|
| Current smoker |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Placebo |
Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months. |
|
|
|
| OG001 | Placebo | Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months. |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|