Durvalumab ± Tremelimumab in Combination With Platinum Ba... | NCT03043872 | Trialant
NCT03043872
Sponsor
AstraZeneca
Status
Active, not recruiting
Last Update Posted
Apr 22, 2026Actual
Enrollment
987Actual
Phase
Phase 3
Conditions
Small Cell Lung Carcinoma Extensive Disease
Interventions
Durvalumab
Tremelimumab
Carboplatin
Cisplatin
Etoposide
Countries
United States
Argentina
Austria
Brazil
Bulgaria
China
Czechia
France
Germany
Hungary
Israel
Italy
Japan
Netherlands
Poland
Romania
Russia
Slovakia
South Korea
Spain
Taiwan
Turkey (Türkiye)
Ukraine
Protocol Section
Identification Module
NCT ID
NCT03043872
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D419QC00001
Secondary IDs
ID
Type
Description
Link
2016-001203-23
EudraCT Number
Brief Title
Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)
Official Title
A Phase III, Randomized, Multicenter,Open-Label, Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients With Extensive Disease Small-Cell Lung Cancer (SCLC) (CASPIAN)
Acronym
CASPIAN
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Apr 2026
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 27, 2017Actual
Primary Completion Date
Jan 27, 2020Actual
Completion Date
Dec 31, 2026Estimated
First Submitted Date
Jan 18, 2017
First Submission Date that Met QC Criteria
Feb 3, 2017
First Posted Date
Feb 6, 2017Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 21, 2021
Results First Submitted that Met QC Criteria
Feb 10, 2021
Results First Posted Date
Mar 4, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 9, 2026
Last Update Posted Date
Apr 22, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line treatment in patients with extensive-stage small-cell lung cancer
Detailed Description
Primary objective of this study is to assess the efficacy of durvalumab + tremelimumab + EP treatment compared with EP and the efficacy of durvalumab + EP treatment compared with EP in terms of OS.
All patients will be randomized in a 1:1:1 ratio in a stratified manner according to the planned platinum-based therapy for Cycle 1 (cisplatin or carboplatin) to receive treatment with durvalumab + tremelimumab + EP (Arm 1), durvalumab + EP (Arm 2), or standard of care- EP (Arm 3). Arm 1 and Arm 2 patients receive the treatment until confirmed disease progression while Arm 3 patients receive up to 6 cycles of EP and prophylactic cranial irradiation if clinically indicated, at the Investigators' discretion.Patients who have discontinued treatment due to toxicity or symptomatic deterioration, clinical progression, or who have commenced subsequent anticancer therapy will be followed up until confirmed disease progression and for survival.
Targeted population are adult patients (aged ≥18 years) with histologically or cytologically documented extensive disease (American Joint Committee on Cancer Stage (7th edition) IV SCLC [T any, N any,M1 a/b]), or T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. Patients must have WHO/ECOG performance status of 0 or 1.
Tumor assessments will be performed at Screening as baseline with follow-up at Week 6 ±1 week from the date of randomization, at Week 12 ±1 week from the date of randomization, and then every 8 weeks ±1 week until confirmed objective disease progression.
An independent data monitoring committee (IDMC) comprised of independent experts will be convened to confirm the safety and tolerability of the proposed dose and schedule of durvalumab ± tremelimumab in combination with platinum based chemotherapy at two early stages of enrolment.
Conditions Module
Conditions
Small Cell Lung Carcinoma Extensive Disease
Keywords
Carcinoma, Small Cell Lung
Oat Cell Carcinoma of Lung
Oat Cell Lung Cancer
Small Cell Cancer Of The Lung
Small Cell Lung Cancer
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
987Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm 1
Experimental
durvalumab+tremelimumab+EP (carboplatin or cisplatin + etoposide)
Drug: Durvalumab
Drug: Tremelimumab
Drug: Carboplatin
Drug: Cisplatin
Drug: Etoposide
Arm 2
Experimental
durvalumab+EP (carboplatin or cisplatin + etoposide)
Drug: Durvalumab
Drug: Carboplatin
Drug: Cisplatin
Drug: Etoposide
Arm 3
Active Comparator
EP (carboplatin or cisplatin + etoposide)
Drug: Carboplatin
Drug: Cisplatin
Drug: Etoposide
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Durvalumab
Drug
IV infusions every 3 weeks for 12 weeks (4 cycles) and every 4 weeks thereafter until PD or other discontinuation criteria.
Arm 1
Arm 2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP
OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An interim analysis of OS in the global cohort was pre-specified after approximately 318 OS events occurred each between the D + EP and EP groups (60% maturity), and between the D + T + EP and EP groups (60% maturity). At the global cohort interim analysis DCO (11 March 2019), comparison of OS in the D + EP versus (vs) EP groups had crossed the pre-specified boundary. Since these results were considered final in terms of formal statistical testing, they are presented here as a primary outcome measure. Analysis of OS for D + EP vs EP and for D + T + EP vs EP at the time of the global cohort final analysis is presented separately in the subsequent primary outcome measure.
From baseline until death due to any cause. Assessed until global cohort interim analysis DCO (maximum of approximately 23 months).
OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP
OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This primary outcome measure presents OS for the analysis of D + EP vs EP and D + T + EP vs EP at the time of the global cohort final analysis DCO (27 January 2020). Analysis of D + EP vs EP at the global cohort interim analysis DCO is presented in the previous primary outcome measure. Analysis of D + T + EP vs D + EP (global cohort final analysis) is presented as a secondary outcome measure.
From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP
OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An analysis of OS for D + EP vs EP in the China cohort was pre-specified at approximately 60% maturity (to ensure a similar maturity to the interim analysis of the Global cohort). This primary outcome measure presents OS for analysis of D + EP vs EP at the China cohort first analysis DCO (06 January 2020), and is comparable in terms of maturity with the interim analysis of OS for D + EP vs EP in the Global cohort. Analysis of OS for D + EP vs EP and for D + T + EP vs EP at the time of the China cohort second analysis is presented separately in the subsequent primary outcome measure.
Secondary Outcomes
Measure
Description
Time Frame
OS in the Global Cohort; D + T + EP Compared With D + EP
OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This secondary outcome measure presents OS for the analysis of D + T + EP vs D + EP in the global cohort. The alternative treatment comparisons in the global cohort were performed as primary outcome measures.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Histologically or cytologically documented extensive disease. Brain metastases; must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment.
Suitable to receive a platinum-based chemotherapy regimen as 1st line treatment.
Life expectancy ≥12 weeks at Day 1.
ECOG 0 or 1 at enrolment.
No prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines.
Exclusion criteria:
Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy (except paliative care outside of the chest).
Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS
Active infection including tuberculosis, HIV, hepatitis B anc C
Active or prior documented autoimmune or inflammatory disorders
Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
Ozguroglu M, Goldman JW, Chen Y, Garassino MC, Medic N, Mann H, Chugh P, Dalvi T, Paz-Ares L. Adverse events self-reported by patients with extensive-stage small-cell lung cancer in the phase III CASPIAN study. Future Oncol. 2025 May;21(12):1511-1523. doi: 10.1080/14796694.2025.2491297. Epub 2025 May 7.
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.
When a request has been approved AstraZeneca will provide access to the de-identified 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.
Patients were randomized in a 1:1:1 ratio to receive treatment with durvalumab + tremelimumab + etoposide and platinum-based chemotherapy (EP), durvalumab + EP or EP alone. 987 participants were randomized in the study overall. Patients included in both cohorts for Started, Completed and Reasons for Not Completed are not double-counted for participant flow.
Recruitment Details
Study was conducted in 209 study centers across 23 countries. It included a global cohort (805 patients) and China cohort (188 patients). China cohort comprised 6 patients also in the global cohort and a further 182 patients randomized after end of global cohort recruitment. Results of the global and China cohorts were reported separately.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
All Patients: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 milligrams (mg) in combination with tremelimumab (T) 75 mg intravenous (IV) infusion every 3 weeks (Q3W) for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/meters squared [m^2]) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion every 4 weeks (Q4W) from Week 12 until progressive disease (PD), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Randomized in overall study
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 16, 2020
Oct 20, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Tremelimumab
Drug
IV infusions every 3 weeks for 12 weeks(4 cycles). An additional dose of tremelimumab will be administered in the week 16.
Arm 1
Carboplatin
Drug
up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3
Arm 1
Arm 2
Arm 3
Cisplatin
Drug
up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3
Arm 1
Arm 2
Arm 3
Etoposide
Drug
up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3
Arm 1
Arm 2
Arm 3
From baseline until death due to any cause. Assessed until China cohort first analysis DCO (maximum of approximately 19 months).
OS in the China Cohort; Assessed at China Cohort Second Analysis; D + EP Compared With EP and D + T + EP Compared With EP
OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An analysis of OS for D + T + EP vs EP in the China cohort was pre-specified at approximately 80% maturity (to ensure a similar maturity to the final analysis of the Global cohort). This primary outcome measure presents OS for analysis of D + EP vs EP and D + T + EP vs EP at the time of the China cohort second analysis DCO (02 November 2020), and is comparable in terms of maturity with the final analysis of OS for D + EP vs EP and D + T + EP vs EP in the Global cohort. Analysis of D + EP vs EP at the China cohort first analysis DCO is presented in the previous primary outcome measure. Analysis of D + T + EP vs D + EP (China cohort second analysis) is presented as a secondary outcome measure.
From baseline until death due to any cause. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
Progression-Free Survival (PFS) in the Global Cohort
PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST 1.1] using Investigator assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (ie, PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir) and an absolute increase of ≥5 millimeters (mm) for the sum from nadir. For evaluation of non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Median PFS was calculated using the Kaplan-Meier technique.
Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
Objective Response Rate (ORR) in the Global Cohort
ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of patients with at least 1 visit response of Complete Response (CR) or Partial Response (PR). CR was defined as disappearance of all TLs since baseline (any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm) or disappearance of all NTLs since baseline (all lymph nodes must be non-pathological in size [<10 mm short axis]). PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters).
Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
Percentage of Patients Alive and Progression Free at 6 Months (APF6) in the Global Cohort
The APF6 was defined as the percentage of patients who were alive and progression free at 6 months from randomization (ie, PFS rate at 6 months). PFS was calculated using the Kaplan-Meier technique.
Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 6 months post-randomization.
Percentage of Patients Alive and Progression Free at 12 Months (APF12) in the Global Cohort
The APF12 was defined as the percentage of patients who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months). PFS was calculated using the Kaplan-Meier technique.
Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 12 months post-randomization.
Percentage of Patients Alive at 18 Months (OS18) in the Global Cohort
OS18 was defined as the percentage of patients who were alive at 18 months after randomization per the Kaplan-Meier estimate of OS at 18 months.
At 18 months post-randomization. Assessed at the global cohort final analysis DCO (27 January 2020).
Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations in the Global Cohort
To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of durvalumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.
Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the global cohort final analysis DCO (27 January 2020).
PK of Tremelimumab; Peak and Trough Serum Concentrations in the Global Cohort
To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of tremelimumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.
Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the global cohort final analysis DCO (27 January 2020).
Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab in the Global Cohort
Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of neutralizing antibody (nAb) was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to durvalumab for each indicated category.
Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, durvalumab). Assessed at the global cohort final analysis DCO (27 January 2020).
Number of Patients With ADA Response to Tremelimumab in the Global Cohort
Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA (or ADA incidence) was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to tremelimumab for each indicated category.
Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, tremelimumab). Assessed at the global cohort final analysis DCO (27 January 2020).
Time to Deterioration of Health-Related Quality of Life (HRQoL) and Patient Reported Outcome (PRO) Symptoms, Assessed Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) in the Global Cohort
The EORTC QLQ-Core 30 version 3 (QLQ-C30 v3) was included for assessing HRQoL. It assesses HRQoL/health status through 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and a global health and QoL scale. 6 single-item symptom measures are also included: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Scores from 0 to 100 were derived for each of the 15 domains, with higher scores representing greater functioning, greater HRQoL, or greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.
At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-Lung Cancer Module 13 (QLQ-LC13) in the Global Cohort
The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, hemoptysis, dyspnea, and pain) and side effects from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (an increase in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.
At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
Change From Baseline in Primary PRO Symptoms as Assessed by EORTC QLQ in the Global Cohort; D + T + EP Compared With EP
A mixed model repeated measures (MMRM) analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as >75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + T + EP vs P. Analysis of D + EP vs EP is presented in a separate outcome measure.
At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.
Change From Baseline in Primary Symptoms, Assessed Using EORTC QLQ-C30 and EORTC QLQ-LC13 in the Global Cohort; D + EP Compared With EP
A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as >75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + EP vs EP. Analysis of D + T + EP vs EP is presented in a separate outcome measure.
At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.
OS in the China Cohort; D + T + EP Compared With D + EP
OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This secondary outcome measure presents OS for the analysis of D + T + EP vs D + EP at the China cohort second analysis DCO (02 November 2020). The alternative treatment comparisons were performed as primary outcome measures.
From baseline until death due to any cause. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
PFS in the China Cohort
PFS (per RECIST 1.1 using Investigator assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (ie, PD) was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) and an absolute increase of ≥5 mm for the sum from nadir. For evaluation of NTLs, PD was defined as unequivocal progression of existing NTLs. Median PFS was calculated using the Kaplan-Meier technique.
Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
ORR in the China Cohort
ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of patients with at least 1 visit response of CR or PR. CR was defined as disappearance of all TLs since baseline (any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm) or disappearance of all NTLs since baseline (all lymph nodes must be non-pathological in size [<10 mm short axis]). PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters).
Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
APF6 in the China Cohort
The APF6 was defined as the percentage of patients who were alive and progression free at 6 months from randomization (ie, PFS rate at 6 months). PFS was calculated using the Kaplan-Meier technique.
Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 6 months post-randomization.
APF12 in the China Cohort
The APF12 was defined as the percentage of patients who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months). PFS was calculated using the Kaplan-Meier technique.
Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 12 months post-randomization.
OS18 in the China Cohort
OS18 was defined as the percentage of patients who were alive at 18 months after randomization per the Kaplan-Meier estimate of OS at 18 months.
At 18 months post-randomization. Assessed at the China cohort second analysis DCO (02 November 2020).
PK of Durvalumab; Peak and Trough Serum Concentrations in the China Cohort
To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of durvalumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.
Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the China cohort second analysis DCO (02 November 2020).
PK of Tremelimumab; Peak and Trough Serum Concentrations in the China Cohort
To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of tremelimumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.
Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the China cohort second analysis DCO (02 November 2020).
Number of Patients With ADA Response to Durvalumab in the China Cohort
Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to durvalumab for each indicated category.
Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, durvalumab). Assessed at the China cohort second analysis DCO (02 November 2020).
Number of Patients With ADA Response to Tremelimumab in the China Cohort
Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA (or ADA incidence) was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to tremelimumab for each indicated category.
Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, tremelimumab). Assessed at the China cohort second analysis DCO (02 November 2020).
Time to Deterioration of HRQoL and PRO Symptoms, Assessed Using EORTC QLQ in the China Cohort
The EORTC QLQ-C30 v3 was included for assessing HRQoL. It assesses HRQoL/health status through 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and a global health and QoL scale. 6 single-item symptom measures are also included: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Scores from 0 to 100 were derived for each of the 15 domains, with higher scores representing greater functioning, greater HRQoL, or greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.
At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-LC13 in the China Cohort
The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, hemoptysis, dyspnea, and pain) and side effects from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (an increase in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.
At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
Change From Baseline in Primary PRO Symptoms, Assessed Using EORTC QLQ-C30 and EORTC QLQ-LC13 in the China Cohort; D + T + EP Compared With EP
A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as >75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + T + EP vs EP. Analysis of D + EP vs EP is presented in a separate outcome measure.
At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.
Change From Baseline in Primary Symptoms as Assessed by EORTC QLQ in the China Cohort; D + EP Compared With EP
A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as >75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + EP vs EP. Analysis of D + T + EP vs EP is presented in a separate outcome measure.
At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.
Scottsdale
Arizona
85259
United States
Research Site
Rogers
Arkansas
72758
United States
Research Site
Santa Monica
California
90404
United States
Research Site
New Haven
Connecticut
06520
United States
Research Site
Athens
Georgia
30607
United States
Research Site
Fort Wayne
Indiana
46804
United States
Research Site
Muncie
Indiana
47303
United States
Research Site
Leawood
Kansas
66209
United States
Research Site
Wichita
Kansas
67214
United States
Research Site
Paducah
Kentucky
42003
United States
Research Site
Grand Rapids
Michigan
49503
United States
Research Site
Mineola
New York
11501
United States
Research Site
Cleveland
Ohio
44106
United States
Research Site
Columbus
Ohio
43219
United States
Research Site
Harrisburg
Pennsylvania
17109
United States
Research Site
Sioux Falls
South Dakota
57104
United States
Research Site
Nashville
Tennessee
37203
United States
Research Site
Kennewick
Washington
99336
United States
Research Site
Buenos Aires
C1118AAT
Argentina
Research Site
Ciudad de Buenos Aires
C1426
Argentina
Research Site
Mar del Plata
7600
Argentina
Research Site
Rosario
2000
Argentina
Research Site
San Miguel de Tucumán
T4000IAK
Argentina
Research Site
Linz
4021
Austria
Research Site
Salzburg
5020
Austria
Research Site
Vienna
1140
Austria
Research Site
Vienna
1210
Austria
Research Site
Barretos
14784-400
Brazil
Research Site
Curitiba
81520-060
Brazil
Research Site
Passo Fundo
99010 260
Brazil
Research Site
Porto Alegre
91350-200
Brazil
Research Site
Ribeirão Preto
14048-900
Brazil
Research Site
Rio de Janeiro
22793-080
Brazil
Research Site
Salvador
41.950-610
Brazil
Research Site
Santo André
09060-650
Brazil
Research Site
São José do Rio Preto
15090-000
Brazil
Research Site
São Paulo
03102-002
Brazil
Research Site
Panagyurishte
4500
Bulgaria
Research Site
Plovdiv
4000
Bulgaria
Research Site
Plovdiv
4004
Bulgaria
Research Site
Sofia
1330
Bulgaria
Research Site
Sofia
1431
Bulgaria
Research Site
Sofia
1618
Bulgaria
Research Site
Sofia
1784
Bulgaria
Research Site
Varna
9010
Bulgaria
Research Site
Beijing
100142
China
Research Site
Beijing
100730
China
Research Site
Beijing
100853
China
Research Site
Bengbu
233004
China
Research Site
Changchun
130021
China
Research Site
Changsha
410013
China
Research Site
Chengdu
610041
China
Research Site
Chongqing
400038
China
Research Site
Hangzhou
310003
China
Research Site
Hangzhou
310006
China
Research Site
Hangzhou
310009
China
Research Site
Hefei
230601
China
Research Site
Nanchang
330006
China
Research Site
Nanjing
210009
China
Research Site
Nanjing
210029
China
Research Site
Shanghai
200032
China
Research Site
Shanghai
200433
China
Research Site
Shenyang
110042
China
Research Site
Ürümqi
830000
China
Research Site
Wenzhou
325000
China
Research Site
Wuhan
430022
China
Research Site
Wuhan
430030
China
Research Site
Xi'an
710038
China
Research Site
Xi'an
710061
China
Research Site
Zhanjiang
524001
China
Research Site
Zhengzhou
450008
China
Research Site
Zhuhai
519099
China
Research Site
Brno
639 00
Czechia
Research Site
Olomouc
775 21
Czechia
Research Site
Ostrava - Vitkovice
703 84
Czechia
Research Site
Prague
128 08
Czechia
Research Site
Prague
140 59
Czechia
Research Site
Prague
CZ-150 18
Czechia
Research Site
Avignon
84918
France
Research Site
Brest
29609
France
Research Site
Créteil
94010
France
Research Site
La Tronche
38043
France
Research Site
Pierre-Bénite
69310
France
Research Site
Rennes
35033
France
Research Site
Aachen
52074
Germany
Research Site
Berlin
13125
Germany
Research Site
Gauting
82131
Germany
Research Site
Gera
07548
Germany
Research Site
Hamburg
20251
Germany
Research Site
Heidelberg
69126
Germany
Research Site
Mainz
55131
Germany
Research Site
Regensburg
93053
Germany
Research Site
Budapest
1083
Hungary
Research Site
Budapest
1106
Hungary
Research Site
Budapest
1121
Hungary
Research Site
Budapest
1134
Hungary
Research Site
Deszk
6772
Hungary
Research Site
Gyula
5700
Hungary
Research Site
Kaposvár
7400
Hungary
Research Site
Kecskemét
6000
Hungary
Research Site
Miskolc
3529
Hungary
Research Site
Pécs
7624
Hungary
Research Site
Székesfehérvár
8000
Hungary
Research Site
Jerusalem
91031
Israel
Research Site
Kfar Saba
95847
Israel
Research Site
Petah Tikva
49100
Israel
Research Site
Ramat Gan
5265601
Israel
Research Site
Bergamo
24127
Italy
Research Site
Meldola
47014
Italy
Research Site
Milan
20133
Italy
Research Site
Palermo
90146
Italy
Research Site
Roma
00100
Italy
Research Site
Terni
05100
Italy
Research Site
Chūōku
104-0045
Japan
Research Site
Fukuoka
812-8582
Japan
Research Site
Fukushima
960-1295
Japan
Research Site
Himeji-shi
670-8520
Japan
Research Site
Iwakuni-shi
740-8510
Japan
Research Site
Kashiwa
227-8577
Japan
Research Site
Kōtoku
135-8550
Japan
Research Site
Kurume-shi
830-0011
Japan
Research Site
Kyoto
606-8507
Japan
Research Site
Matsuyama
791-0280
Japan
Research Site
Nagoya
464-8681
Japan
Research Site
Nagoya
466-8560
Japan
Research Site
Okayama
700-8558
Japan
Research Site
Sakaishi
591-8555
Japan
Research Site
Sayama
589-8511
Japan
Research Site
Tokushima
770-8503
Japan
Research Site
Ube-shi
755-0241
Japan
Research Site
Yokohama
236-0004
Japan
Research Site
Yokohama
241-8515
Japan
Research Site
Amsterdam
1066 CX
Netherlands
Research Site
Arnhem
6815 AD
Netherlands
Research Site
Groningen
9713 GZ
Netherlands
Research Site
Hengelo
7555 DL
Netherlands
Research Site
Maastricht
6202 AZ
Netherlands
Research Site
Rotterdam
3015 GD
Netherlands
Research Site
Bialystok
15-027
Poland
Research Site
Bialystok
15-540
Poland
Research Site
Lublin
20-954
Poland
Research Site
Olsztyn
10-357
Poland
Research Site
Warsaw
02-781
Poland
Research Site
Cluj-Napoca
400015
Romania
Research Site
Floreşti
407280
Romania
Research Site
Suceava
720237
Romania
Research Site
Moscow
105229
Russia
Research Site
Omsk
644013
Russia
Research Site
Rostov-on-Don
344037
Russia
Research Site
Saint Petersburg
194291
Russia
Research Site
Saint Petersburg
195271
Russia
Research Site
Saint Petersburg
196603
Russia
Research Site
Saint Petersburg
197758
Russia
Research Site
Ufa
450054
Russia
Research Site
Banská Bystrica
97517
Slovakia
Research Site
Bardejov
085 01
Slovakia
Research Site
Bratislava
82606
Slovakia
Research Site
Bratislava
833 01
Slovakia
Research Site
Košice
041 91
Slovakia
Research Site
Nové Zámky
940 01
Slovakia
Research Site
Trnava
91708
Slovakia
Research Site
Changwon
51353
South Korea
Research Site
Cheongju-si
28644
South Korea
Research Site
Daegu
42415
South Korea
Research Site
Incheon
21565
South Korea
Research Site
Jinju
660-702
South Korea
Research Site
Seongnam-si
13620
South Korea
Research Site
Seongnam-si
463-712
South Korea
Research Site
Seoul
05505
South Korea
Research Site
Seoul
110746
South Korea
Research Site
A Coruña
15006
Spain
Research Site
Badajoz
06008
Spain
Research Site
Badalona
08916
Spain
Research Site
Barcelona
08041
Spain
Research Site
Madrid
08035
Spain
Research Site
Madrid
28040
Spain
Research Site
Madrid
28041
Spain
Research Site
Santander
39008
Spain
Research Site
Valencia
46010
Spain
Research Site
Zaragoza
50009
Spain
Research Site
Changhua
50006
Taiwan
Research Site
Kaohsiung City
82445
Taiwan
Research Site
Kaohsiung City
83301
Taiwan
Research Site
Taichung
40447
Taiwan
Research Site
Taichung
40705
Taiwan
Research Site
Tainan
704
Taiwan
Research Site
Tainan
736
Taiwan
Research Site
Taipei
11217
Taiwan
Research Site
Taipei
235
Taiwan
Research Site
Ankara
06230
Turkey (Türkiye)
Research Site
Ankara
Turkey (Türkiye)
Research Site
Edirne
22030
Turkey (Türkiye)
Research Site
Istanbul
32098
Turkey (Türkiye)
Research Site
Izmir
35100
Turkey (Türkiye)
Research Site
Izmir
35620
Turkey (Türkiye)
Research Site
Dnipro
49102
Ukraine
Research Site
Ivano-Frankivsk
76018
Ukraine
Research Site
Kirovohrad
25006
Ukraine
Research Site
Kryvyi Rih
50048
Ukraine
Research Site
Kyiv
03022
Ukraine
Research Site
Kyiv
03115
Ukraine
Research Site
Lviv
79031
Ukraine
Research Site
Odesa
65055
Ukraine
Research Site
Sumy
40022
Ukraine
Research Site
Vinnytsia
21029
Ukraine
Research Site
Zaporizhzhia
69040
Ukraine
Xie M, Vuko M, Rodriguez-Canales J, Zimmermann J, Schick M, O'Brien C, Paz-Ares L, Goldman JW, Garassino MC, Gay CM, Heymach JV, Jiang H, Barrett JC, Stewart RA, Lai Z, Byers LA, Rudin CM, Shrestha Y. Molecular classification and biomarkers of outcome with immunotherapy in extensive-stage small-cell lung cancer: analyses of the CASPIAN phase 3 study. Mol Cancer. 2024 May 30;23(1):115. doi: 10.1186/s12943-024-02014-x.
Goldman JW, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Garassino MC, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Thiyagarajah P, Jiang H, Paz-Ares L; CASPIAN investigators. Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):51-65. doi: 10.1016/S1470-2045(20)30539-8. Epub 2020 Dec 4.
Paz-Ares L, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Shire N, Jiang H, Goldman JW; CASPIAN investigators. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019 Nov 23;394(10212):1929-1939. doi: 10.1016/S0140-6736(19)32222-6. Epub 2019 Oct 4.
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
FG002
All Patients: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
FG000329 subjects
FG001328 subjects
FG002330 subjects
Randomized and Included in Global Cohort Analysis
FG000268 subjects
FG001268 subjects
FG002269 subjects
Received Treatment in Global Cohort
FG000266 subjects
FG001265 subjects
FG002266 subjects
Randomized and Included in China Cohort Analysis
FG00065 subjects
FG00161 subjects
FG00262 subjects
Received Treatment in China Cohort
FG00065 subjects
FG00161 subjects
FG00262 subjects
Included in Both Cohorts (Global + China)
FG0004 subjects
FG0011 subjects
FG0021 subjects
Ongoing Study at Global Cohort Final Analysis Data Cut-off (DCO)
FG00056 subjects
FG00156 subjects
FG00231 subjects
Ongoing Study at China Cohort Second (Final) Analysis DCO
FG00016 subjects
FG00111 subjects
FG0027 subjects
COMPLETED
Ongoing in overall study at long-term follow-up (LTFU) analysis DCO
FG00051 subjects
FG00152 subjects
FG00218 subjects
NOT COMPLETED
FG000278 subjects
FG001276 subjects
FG002312 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0006 subjects
FG0016 subjects
FG00215 subjects
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0021 subjects
Death
FG000270 subjects
FG001269 subjects
FG002296 subjects
Baseline analysis was based on the global full analysis set (FAS) (all patients randomized prior to the end of global recruitment) plus the China FAS (all randomized patients in the China cohort). Patients included in both cohorts are not double-counted for the baseline analysis represented by 'All Patients'.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
All Patients: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
BG001
All Patients: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
BG002
All Patients: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000329
BG001328
BG002330
BG003987
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Baseline data is presented for all patients, as well as separately for the global and China cohorts.
Count of Participants
Participants
Title
Denominators
Categories
Al Patients
ParticipantsBG000329
ParticipantsBG001328
ParticipantsBG002330
ParticipantsBG003
Sex: Female, Male
Baseline data is presented for all patients, as well as separately for the global and China cohorts.
Count of Participants
Participants
Title
Denominators
Categories
All Patients
ParticipantsBG000329
ParticipantsBG001328
ParticipantsBG002
Ethnicity (NIH/OMB)
Baseline data is presented for all patients, as well as separately for the global and China cohorts.
Count of Participants
Participants
Title
Denominators
Categories
All Patients
ParticipantsBG000329
ParticipantsBG001328
ParticipantsBG002
Race
Baseline data is presented for all patients, as well as separately for the global and China cohorts.
Count of Participants
Participants
Title
Denominators
Categories
All Patients
ParticipantsBG000329
ParticipantsBG001328
ParticipantsBG002
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
Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP
OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An interim analysis of OS in the global cohort was pre-specified after approximately 318 OS events occurred each between the D + EP and EP groups (60% maturity), and between the D + T + EP and EP groups (60% maturity). At the global cohort interim analysis DCO (11 March 2019), comparison of OS in the D + EP versus (vs) EP groups had crossed the pre-specified boundary. Since these results were considered final in terms of formal statistical testing, they are presented here as a primary outcome measure. Analysis of OS for D + EP vs EP and for D + T + EP vs EP at the time of the global cohort final analysis is presented separately in the subsequent primary outcome measure.
The global FAS included all patients randomized prior to the end of global recruitment. Interim analysis for OS in the global cohort was performed for comparison of the D + EP vs EP groups only.
Posted
Median
95% Confidence Interval
months
From baseline until death due to any cause. Assessed until global cohort interim analysis DCO (maximum of approximately 23 months).
ID
Title
Description
OG000
Global Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
OG001
Global Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG000268
OG001269
Title
Denominators
Categories
Title
Measurements
OG00013.0(11.5 to 14.8)
OG00110.3(9.3 to 11.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
D + EP vs EP. The global cohort interim analysis of OS was based on a Lan-DeMets alpha spending function with O'Brien Fleming type boundary, using the actual number of events observed as a proportion of the planned total. Boundary for declaring statistical significance was 0.0178 for a 4% overall alpha. Hazard Ratio (HR) <1 favors D + EP to be associated with a longer OS than EP.
Log Rank
0.0047
Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.
Hazard Ratio (HR)
0.73
2-Sided
95
0.591
0.909
The HR and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.
Primary
OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP
OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This primary outcome measure presents OS for the analysis of D + EP vs EP and D + T + EP vs EP at the time of the global cohort final analysis DCO (27 January 2020). Analysis of D + EP vs EP at the global cohort interim analysis DCO is presented in the previous primary outcome measure. Analysis of D + T + EP vs D + EP (global cohort final analysis) is presented as a secondary outcome measure.
The global FAS included all patients randomized prior to the end of global recruitment.
Posted
Median
95% Confidence Interval
months
From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
ID
Title
Description
OG000
Global Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Primary
OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP
OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An analysis of OS for D + EP vs EP in the China cohort was pre-specified at approximately 60% maturity (to ensure a similar maturity to the interim analysis of the Global cohort). This primary outcome measure presents OS for analysis of D + EP vs EP at the China cohort first analysis DCO (06 January 2020), and is comparable in terms of maturity with the interim analysis of OS for D + EP vs EP in the Global cohort. Analysis of OS for D + EP vs EP and for D + T + EP vs EP at the time of the China cohort second analysis is presented separately in the subsequent primary outcome measure.
The China FAS included all randomized patients in the China cohort. China cohort first analysis for OS was performed for comparison of the D + EP vs EP groups only.
Posted
Median
95% Confidence Interval
months
From baseline until death due to any cause. Assessed until China cohort first analysis DCO (maximum of approximately 19 months).
ID
Title
Description
OG000
China Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Primary
OS in the China Cohort; Assessed at China Cohort Second Analysis; D + EP Compared With EP and D + T + EP Compared With EP
OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An analysis of OS for D + T + EP vs EP in the China cohort was pre-specified at approximately 80% maturity (to ensure a similar maturity to the final analysis of the Global cohort). This primary outcome measure presents OS for analysis of D + EP vs EP and D + T + EP vs EP at the time of the China cohort second analysis DCO (02 November 2020), and is comparable in terms of maturity with the final analysis of OS for D + EP vs EP and D + T + EP vs EP in the Global cohort. Analysis of D + EP vs EP at the China cohort first analysis DCO is presented in the previous primary outcome measure. Analysis of D + T + EP vs D + EP (China cohort second analysis) is presented as a secondary outcome measure.
The China FAS included all randomized patients in the China cohort.
Posted
Median
95% Confidence Interval
months
From baseline until death due to any cause. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
ID
Title
Description
OG000
China Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
OS in the Global Cohort; D + T + EP Compared With D + EP
OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This secondary outcome measure presents OS for the analysis of D + T + EP vs D + EP in the global cohort. The alternative treatment comparisons in the global cohort were performed as primary outcome measures.
The global FAS included all patients randomized prior to the end of global recruitment.
Posted
Median
95% Confidence Interval
months
From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
ID
Title
Description
OG000
Global Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
Progression-Free Survival (PFS) in the Global Cohort
PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST 1.1] using Investigator assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (ie, PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir) and an absolute increase of ≥5 millimeters (mm) for the sum from nadir. For evaluation of non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Median PFS was calculated using the Kaplan-Meier technique.
The global FAS included all patients randomized prior to the end of global recruitment.
Posted
Median
95% Confidence Interval
months
Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
ID
Title
Description
OG000
Global Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
Objective Response Rate (ORR) in the Global Cohort
ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of patients with at least 1 visit response of Complete Response (CR) or Partial Response (PR). CR was defined as disappearance of all TLs since baseline (any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm) or disappearance of all NTLs since baseline (all lymph nodes must be non-pathological in size [<10 mm short axis]). PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters).
The global FAS included all patients randomized prior to the end of global recruitment. The denominator was a subset of the FAS population who had measurable disease at baseline.
Posted
Number
percentage of patients
Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
ID
Title
Description
OG000
Global Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
Percentage of Patients Alive and Progression Free at 6 Months (APF6) in the Global Cohort
The APF6 was defined as the percentage of patients who were alive and progression free at 6 months from randomization (ie, PFS rate at 6 months). PFS was calculated using the Kaplan-Meier technique.
The global FAS included all patients randomized prior to the end of global recruitment.
Posted
Number
95% Confidence Interval
percentage of patients
Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 6 months post-randomization.
ID
Title
Description
OG000
Global Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
OG001
Global Cohort: D + EP
Secondary
Percentage of Patients Alive and Progression Free at 12 Months (APF12) in the Global Cohort
The APF12 was defined as the percentage of patients who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months). PFS was calculated using the Kaplan-Meier technique.
The global FAS included all patients randomized prior to the end of global recruitment.
Posted
Number
95% Confidence Interval
percentage of patients
Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 12 months post-randomization.
ID
Title
Description
OG000
Global Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
OG001
Global Cohort: D + EP
Secondary
Percentage of Patients Alive at 18 Months (OS18) in the Global Cohort
OS18 was defined as the percentage of patients who were alive at 18 months after randomization per the Kaplan-Meier estimate of OS at 18 months.
The global FAS included all patients randomized prior to the end of global recruitment.
Posted
Number
95% Confidence Interval
percentage of patients
At 18 months post-randomization. Assessed at the global cohort final analysis DCO (27 January 2020).
ID
Title
Description
OG000
Global Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
OG001
Global Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Secondary
Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations in the Global Cohort
To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of durvalumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.
The global PK analysis set included all patients randomized prior to the end of global recruitment who received at least 1 dose of investigational product (IP), per the protocol for whom any post-dose PK data were available. PK for durvalumab was performed for the D + T + EP and D + EP groups only.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms/milliliter (μg/mL)
Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the global cohort final analysis DCO (27 January 2020).
ID
Title
Description
OG000
Global Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
PK of Tremelimumab; Peak and Trough Serum Concentrations in the Global Cohort
To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of tremelimumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.
The global PK analysis set included all patients randomized prior to the end of global recruitment who received at least 1 dose of IP, per the protocol for whom any post-dose PK data were available. PK for tremelimumab was performed for the D + T + EP group only.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the global cohort final analysis DCO (27 January 2020).
ID
Title
Description
OG000
Global Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab in the Global Cohort
Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of neutralizing antibody (nAb) was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to durvalumab for each indicated category.
The global ADA evaluable patients included those in the global safety analysis set who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. ADA for durvalumab was performed for the D + T + EP and D + EP groups only. The denominator was durvalumab ADA evaluable patients.
Posted
Count of Participants
Participants
Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, durvalumab). Assessed at the global cohort final analysis DCO (27 January 2020).
ID
Title
Description
OG000
Global Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
Number of Patients With ADA Response to Tremelimumab in the Global Cohort
Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA (or ADA incidence) was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to tremelimumab for each indicated category.
The global ADA evaluable patients included those in the global safety analysis set who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. ADA for tremelimumab was performed for the D + T + EP group only. The denominator was tremelimumab ADA evaluable patients.
Posted
Count of Participants
Participants
Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, tremelimumab). Assessed at the global cohort final analysis DCO (27 January 2020).
ID
Title
Description
OG000
Global Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
Time to Deterioration of Health-Related Quality of Life (HRQoL) and Patient Reported Outcome (PRO) Symptoms, Assessed Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) in the Global Cohort
The EORTC QLQ-Core 30 version 3 (QLQ-C30 v3) was included for assessing HRQoL. It assesses HRQoL/health status through 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and a global health and QoL scale. 6 single-item symptom measures are also included: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Scores from 0 to 100 were derived for each of the 15 domains, with higher scores representing greater functioning, greater HRQoL, or greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.
The global FAS included all patients randomized prior to the end of global recruitment. For QLQ-C30 function scales and global health status/HRQoL, only patients with baseline scores ≥10 (and with data available) were included in the analysis. For QLQ-C30 symptom scales/items, only patients with baseline scores ≤90 (and with data available) were included in the analysis.
Posted
Median
95% Confidence Interval
months
At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
ID
Title
Description
Secondary
Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-Lung Cancer Module 13 (QLQ-LC13) in the Global Cohort
The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, hemoptysis, dyspnea, and pain) and side effects from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (an increase in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.
The global FAS included all patients randomized prior to the end of global recruitment. For QLQ-L13 symptom scales/items, only patients with baseline scores ≤90 (and with data available) were included in the analysis.
Posted
Median
95% Confidence Interval
months
At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
ID
Title
Description
OG000
Global Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
Change From Baseline in Primary PRO Symptoms as Assessed by EORTC QLQ in the Global Cohort; D + T + EP Compared With EP
A mixed model repeated measures (MMRM) analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as >75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + T + EP vs P. Analysis of D + EP vs EP is presented in a separate outcome measure.
The global FAS included all patients randomized prior to the end of global recruitment. For each symptom scale, only patients with data available were included in the analysis.
Posted
Mean
Standard Error
scores on a scale
At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.
ID
Title
Description
OG000
Global Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
Change From Baseline in Primary Symptoms, Assessed Using EORTC QLQ-C30 and EORTC QLQ-LC13 in the Global Cohort; D + EP Compared With EP
A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as >75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + EP vs EP. Analysis of D + T + EP vs EP is presented in a separate outcome measure.
The global FAS included all patients randomized prior to the end of global recruitment. For each symptom scale, only patients with data available were included in the analysis.
Posted
Mean
Standard Error
scores on a scale
At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.
ID
Title
Description
OG000
Global Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Secondary
OS in the China Cohort; D + T + EP Compared With D + EP
OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This secondary outcome measure presents OS for the analysis of D + T + EP vs D + EP at the China cohort second analysis DCO (02 November 2020). The alternative treatment comparisons were performed as primary outcome measures.
The China FAS included all randomized patients in the China cohort.
Posted
Median
95% Confidence Interval
months
From baseline until death due to any cause. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
ID
Title
Description
OG000
China Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
PFS in the China Cohort
PFS (per RECIST 1.1 using Investigator assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (ie, PD) was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) and an absolute increase of ≥5 mm for the sum from nadir. For evaluation of NTLs, PD was defined as unequivocal progression of existing NTLs. Median PFS was calculated using the Kaplan-Meier technique.
The China FAS included all randomized patients in the China cohort.
Posted
Median
95% Confidence Interval
months
Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
ID
Title
Description
OG000
China Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
ORR in the China Cohort
ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of patients with at least 1 visit response of CR or PR. CR was defined as disappearance of all TLs since baseline (any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm) or disappearance of all NTLs since baseline (all lymph nodes must be non-pathological in size [<10 mm short axis]). PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters).
The China FAS included all randomized patients in the China cohort.
Posted
Number
percentage of patients
Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
ID
Title
Description
OG000
China Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
APF6 in the China Cohort
The APF6 was defined as the percentage of patients who were alive and progression free at 6 months from randomization (ie, PFS rate at 6 months). PFS was calculated using the Kaplan-Meier technique.
The China FAS included all randomized patients in the China cohort.
Posted
Number
95% Confidence Interval
percentage of patients
Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 6 months post-randomization.
ID
Title
Description
OG000
China Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
OG001
China Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Secondary
APF12 in the China Cohort
The APF12 was defined as the percentage of patients who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months). PFS was calculated using the Kaplan-Meier technique.
The China FAS included all randomized patients in the China cohort.
Posted
Number
95% Confidence Interval
percentage of patients
Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 12 months post-randomization.
ID
Title
Description
OG000
China Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
OG001
China Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Secondary
OS18 in the China Cohort
OS18 was defined as the percentage of patients who were alive at 18 months after randomization per the Kaplan-Meier estimate of OS at 18 months.
The China FAS included all randomized patients in the China cohort.
Posted
Number
95% Confidence Interval
percentage of patients
At 18 months post-randomization. Assessed at the China cohort second analysis DCO (02 November 2020).
ID
Title
Description
OG000
China Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
OG001
China Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Secondary
PK of Durvalumab; Peak and Trough Serum Concentrations in the China Cohort
To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of durvalumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.
The China PK analysis set included all patients in the China cohort who received at least 1 dose of IP, per the protocol for whom any post-dose PK data were available. PK for durvalumab was performed for the D + T + EP and D + EP groups only.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the China cohort second analysis DCO (02 November 2020).
ID
Title
Description
OG000
China Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
PK of Tremelimumab; Peak and Trough Serum Concentrations in the China Cohort
To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of tremelimumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.
The China PK analysis set included all patients in the China cohort who received at least 1 dose of IP, per the protocol for whom any post-dose PK data were available. PK for tremelimumab was performed for the D + T + EP group only.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the China cohort second analysis DCO (02 November 2020).
ID
Title
Description
OG000
China Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
Number of Patients With ADA Response to Durvalumab in the China Cohort
Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to durvalumab for each indicated category.
The China ADA evaluable patients included those in the China safety analysis set who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. ADA for durvalumab was performed for the D + T + EP and D + EP groups only. The denominator was durvalumab ADA evaluable patients.
Posted
Count of Participants
Participants
Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, durvalumab). Assessed at the China cohort second analysis DCO (02 November 2020).
ID
Title
Description
OG000
China Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
Number of Patients With ADA Response to Tremelimumab in the China Cohort
Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA (or ADA incidence) was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to tremelimumab for each indicated category.
The China ADA evaluable patients included those in the China safety analysis set who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. ADA for tremelimumab was performed for the D + T + EP group only. The denominator was tremelimumab ADA evaluable patients.
Posted
Count of Participants
Participants
Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, tremelimumab). Assessed at the China cohort second analysis DCO (02 November 2020).
ID
Title
Description
OG000
China Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
Time to Deterioration of HRQoL and PRO Symptoms, Assessed Using EORTC QLQ in the China Cohort
The EORTC QLQ-C30 v3 was included for assessing HRQoL. It assesses HRQoL/health status through 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and a global health and QoL scale. 6 single-item symptom measures are also included: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Scores from 0 to 100 were derived for each of the 15 domains, with higher scores representing greater functioning, greater HRQoL, or greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.
The China FAS included all randomized patients in the China cohort. For QLQ-C30 function scales and global health status/HRQoL, only patients with baseline scores ≥10 (and with data available) were included in the analysis. For QLQ-C30 symptom scales/items, only patients with baseline scores ≤90 (and with data available) were included in the analysis.
Posted
Median
95% Confidence Interval
months
At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
ID
Title
Description
OG000
China Cohort: D + T + EP
Secondary
Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-LC13 in the China Cohort
The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, hemoptysis, dyspnea, and pain) and side effects from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (an increase in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.
The China FAS included all randomized patients in the China cohort. For QLQ-L13 symptom scales/items, only patients with baseline scores ≤90 (and with data available) were included in the analysis.
Posted
Median
95% Confidence Interval
months
At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
ID
Title
Description
OG000
China Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
Change From Baseline in Primary PRO Symptoms, Assessed Using EORTC QLQ-C30 and EORTC QLQ-LC13 in the China Cohort; D + T + EP Compared With EP
A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as >75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + T + EP vs EP. Analysis of D + EP vs EP is presented in a separate outcome measure.
The China FAS included all randomized patients in the China cohort. For each symptom scale, only patients with data available were included in the analysis.
Posted
Mean
Standard Error
scores on a scale
At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.
ID
Title
Description
OG000
China Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Secondary
Change From Baseline in Primary Symptoms as Assessed by EORTC QLQ in the China Cohort; D + EP Compared With EP
A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as >75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + EP vs EP. Analysis of D + T + EP vs EP is presented in a separate outcome measure.
The China FAS included all randomized patients in the China cohort. For each symptom scale, only patients with data available were included in the analysis.
Posted
Mean
Standard Error
scores on a scale
At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.
ID
Title
Description
OG000
China Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Time Frame
All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO for each cohort; maximum of approximately 33 months for the Global cohort and maximum of approximately 29 months for the China cohort. Serious AEs and Deaths were collected through LTFU analysis in patients still receiving durvalumab (or within 90 days of discontinuing treatment); up to approximately 4 years.
Description
TEAEs included those from first administration of study treatment up to and including 90 days after last dose of study treatment or up to date of initiation of the first subsequent anticancer therapy (whichever occurred first). Data from the global cohort and China cohort safety analysis sets was summarised separately. 6 patients in the China cohort were also included in the global cohort.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Global Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
225
266
126
266
249
266
EG001
Global Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
218
265
86
265
247
265
EG002
Global Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
247
266
97
266
248
266
EG003
China Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
50
65
31
65
65
65
EG004
China Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
51
61
26
61
61
61
EG005
China Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
55
62
22
62
61
62
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG00011 events9 affected266 at risk
EG0018 events5 affected265 at risk
EG00214 events12 affected266 at risk
EG0032 events2 affected65 at risk
EG0040 events0 affected61 at risk
EG0052 events2 affected62 at risk
Bone marrow failure
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG00012 events11 affected266 at risk
EG00115 events12 affected265 at risk
EG00213 events12 affected266 at risk
EG003
Granulocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Haematotoxicity
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0005 events5 affected266 at risk
EG0012 events2 affected265 at risk
EG00212 events7 affected266 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0003 events2 affected266 at risk
EG0014 events4 affected265 at risk
EG0023 events3 affected266 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0006 events6 affected266 at risk
EG0011 events1 affected265 at risk
EG00211 events9 affected266 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0022 events2 affected266 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0012 events2 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected266 at risk
EG0012 events2 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0011 events1 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Cardiac dysfunction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Cardiac failure chronic
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Left ventricular failure
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Hypoparathyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Hypopituitarism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0005 events5 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Secondary adrenocortical insufficiency
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Angle closure glaucoma
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Retinopathy
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Vitreous detachment
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Acute abdomen
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0012 events2 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0022 events2 affected266 at risk
EG003
Oesophageal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected266 at risk
EG0010 events0 affected265 at risk
EG0023 events3 affected266 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0012 events1 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Condition aggravated
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Death
General disorders
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected266 at risk
EG0010 events0 affected265 at risk
EG0022 events2 affected266 at risk
EG003
Drowning
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Malaise
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0006 events5 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0007 events7 affected266 at risk
EG0012 events2 affected265 at risk
EG0024 events4 affected266 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
General physical health deterioration
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0012 events2 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0022 events2 affected266 at risk
EG003
Sudden cardiac death
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Sudden death
General disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected266 at risk
EG0012 events2 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0003 events2 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Contrast media allergy
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Abdominal sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Bacterial prostatitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Cystitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Device related sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Hepatitis C
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0012 events2 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0011 events1 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0004 events3 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Lung abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00017 events16 affected266 at risk
EG0016 events6 affected265 at risk
EG00212 events11 affected266 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0012 events2 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0013 events3 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Septic shock
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0013 events3 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Systemic candida
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0012 events2 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0011 events1 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Urinary tract infection pseudomonal
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Viral infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Accidental exposure to product
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Radiation pneumonitis
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Body temperature increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Influenza B virus test positive
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Lipase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Liver function test increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Transaminases increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Diabetic ketosis
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Diabetic metabolic decompensation
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0023 events3 affected266 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG00010 events9 affected266 at risk
EG0012 events2 affected265 at risk
EG0025 events4 affected266 at risk
EG003
Ketoacidosis
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0012 events2 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Clear cell renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Laryngeal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0012 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Non-Hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Small intestine leiomyosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0023 events3 affected266 at risk
EG003
Cerebrovascular insufficiency
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0003 events2 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Myasthenia gravis
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Seizure
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0022 events2 affected266 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0012 events2 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Vasogenic cerebral oedema
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Adjustment disorder with depressed mood
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0012 events2 affected265 at risk
EG0022 events2 affected266 at risk
EG003
Azotaemia
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Renal artery thrombosis
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0011 events1 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0012 events2 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Choking
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 events2 affected266 at risk
EG0013 events3 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Chylothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected266 at risk
EG0010 events0 affected265 at risk
EG0023 events3 affected266 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0012 events2 affected265 at risk
EG0022 events2 affected266 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0005 events5 affected266 at risk
EG0013 events3 affected265 at risk
EG0023 events3 affected266 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Pneumothorax spontaneous
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Pulmonary artery thrombosis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0007 events7 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected266 at risk
EG0010 events0 affected265 at risk
EG0022 events1 affected266 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Dermatomyositis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Stevens-Johnson syndrome
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Arterial stenosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0012 events2 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Embolism arterial
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Peripheral artery thrombosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Superior vena cava occlusion
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00054 events40 affected266 at risk
EG00137 events27 affected265 at risk
EG00234 events29 affected266 at risk
EG00326 events16 affected65 at risk
EG0045 events5 affected61 at risk
EG0055 events5 affected62 at risk
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG00047 events37 affected266 at risk
EG00150 events42 affected265 at risk
EG00250 events39 affected266 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG000115 events94 affected266 at risk
EG001110 events97 affected265 at risk
EG002150 events116 affected266 at risk
EG003
Bone marrow failure
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0005 events3 affected266 at risk
EG0014 events4 affected265 at risk
EG0026 events6 affected266 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG00069 events33 affected266 at risk
EG00187 events40 affected265 at risk
EG00269 events32 affected266 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG00012 events8 affected266 at risk
EG00110 events5 affected265 at risk
EG00213 events8 affected266 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG000213 events112 affected266 at risk
EG001221 events110 affected265 at risk
EG002234 events119 affected266 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG00068 events50 affected266 at risk
EG00163 events41 affected265 at risk
EG00283 events48 affected266 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG00026 events26 affected266 at risk
EG00128 events26 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG00033 events28 affected266 at risk
EG00126 events25 affected265 at risk
EG0024 events4 affected266 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00021 events18 affected266 at risk
EG00116 events14 affected265 at risk
EG0028 events7 affected266 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00065 events54 affected266 at risk
EG00153 events43 affected265 at risk
EG00271 events52 affected266 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected266 at risk
EG0011 events1 affected265 at risk
EG0024 events4 affected266 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG000126 events85 affected266 at risk
EG001147 events89 affected265 at risk
EG002140 events88 affected266 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00023 events21 affected266 at risk
EG00110 events8 affected265 at risk
EG0029 events8 affected266 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00044 events36 affected266 at risk
EG00165 events39 affected265 at risk
EG00256 events42 affected266 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG00061 events53 affected266 at risk
EG00161 events48 affected265 at risk
EG00255 events46 affected266 at risk
EG003
Malaise
General disorders
MedDRA 23.0
Systematic Assessment
EG00011 events11 affected266 at risk
EG0018 events7 affected265 at risk
EG0023 events3 affected266 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG00014 events10 affected266 at risk
EG00117 events14 affected265 at risk
EG0028 events7 affected266 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Systematic Assessment
EG00015 events12 affected266 at risk
EG00119 events16 affected265 at risk
EG00210 events9 affected266 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG00053 events36 affected266 at risk
EG00124 events22 affected265 at risk
EG00218 events16 affected266 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0007 events6 affected266 at risk
EG0011 events1 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0008 events6 affected266 at risk
EG00113 events10 affected265 at risk
EG0028 events7 affected266 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00013 events13 affected266 at risk
EG00110 events8 affected265 at risk
EG00213 events13 affected266 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00018 events17 affected266 at risk
EG0016 events5 affected265 at risk
EG0027 events7 affected266 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG00010 events8 affected266 at risk
EG00116 events12 affected265 at risk
EG00213 events11 affected266 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG00025 events20 affected266 at risk
EG00121 events16 affected265 at risk
EG00215 events12 affected266 at risk
EG003
Amylase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0007 events6 affected266 at risk
EG00112 events11 affected265 at risk
EG0022 events2 affected266 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG00022 events19 affected266 at risk
EG00121 events16 affected265 at risk
EG00211 events9 affected266 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG00012 events11 affected266 at risk
EG00117 events13 affected265 at risk
EG0027 events6 affected266 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0005 events5 affected266 at risk
EG0015 events3 affected265 at risk
EG0025 events4 affected266 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected266 at risk
EG0015 events5 affected265 at risk
EG0026 events6 affected266 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0005 events4 affected266 at risk
EG0016 events6 affected265 at risk
EG0028 events8 affected266 at risk
EG003
Blood urea increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0013 events3 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Blood urine present
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG00010 events9 affected266 at risk
EG00113 events13 affected265 at risk
EG0027 events6 affected266 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected266 at risk
EG0013 events3 affected265 at risk
EG0022 events2 affected266 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG00016 events11 affected266 at risk
EG00142 events26 affected265 at risk
EG00249 events31 affected266 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0008 events6 affected266 at risk
EG00120 events16 affected265 at risk
EG00222 events14 affected266 at risk
EG003
Weight decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG00020 events19 affected266 at risk
EG00110 events10 affected265 at risk
EG00210 events9 affected266 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG00011 events9 affected266 at risk
EG00121 events14 affected265 at risk
EG00222 events17 affected266 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG00064 events57 affected266 at risk
EG00160 events48 affected265 at risk
EG00254 events46 affected266 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0009 events5 affected266 at risk
EG00114 events10 affected265 at risk
EG00211 events9 affected266 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG00010 events5 affected266 at risk
EG00110 events5 affected265 at risk
EG0029 events7 affected266 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0003 events2 affected266 at risk
EG0014 events4 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG00014 events9 affected266 at risk
EG0016 events5 affected265 at risk
EG0028 events5 affected266 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected266 at risk
EG0016 events5 affected265 at risk
EG0027 events7 affected266 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0006 events5 affected266 at risk
EG0010 events0 affected265 at risk
EG0020 events0 affected266 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG00022 events19 affected266 at risk
EG00121 events17 affected265 at risk
EG00213 events11 affected266 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG00018 events15 affected266 at risk
EG00120 events18 affected265 at risk
EG00214 events13 affected266 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG00028 events20 affected266 at risk
EG00134 events26 affected265 at risk
EG00211 events9 affected266 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0002 events1 affected266 at risk
EG0010 events0 affected265 at risk
EG0021 events1 affected266 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG00033 events30 affected266 at risk
EG00132 events24 affected265 at risk
EG00224 events18 affected266 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG00015 events14 affected266 at risk
EG00111 events10 affected265 at risk
EG0026 events5 affected266 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0006 events6 affected266 at risk
EG00116 events12 affected265 at risk
EG0024 events4 affected266 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG00020 events15 affected266 at risk
EG00127 events23 affected265 at risk
EG00213 events12 affected266 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG00031 events29 affected266 at risk
EG00119 events17 affected265 at risk
EG00225 events22 affected266 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG00017 events17 affected266 at risk
EG00119 events18 affected265 at risk
EG00215 events13 affected266 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG00027 events25 affected266 at risk
EG00128 events23 affected265 at risk
EG00214 events13 affected266 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0008 events3 affected266 at risk
EG0013 events1 affected265 at risk
EG0025 events3 affected266 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00032 events28 affected266 at risk
EG00136 events35 affected265 at risk
EG00220 events19 affected266 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00031 events24 affected266 at risk
EG00136 events32 affected265 at risk
EG00230 events27 affected266 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00021 events18 affected266 at risk
EG00113 events12 affected265 at risk
EG0026 events5 affected266 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG00018 events10 affected266 at risk
EG00116 events10 affected265 at risk
EG00220 events9 affected266 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0005 events4 affected266 at risk
EG00111 events10 affected265 at risk
EG0027 events6 affected266 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0008 events8 affected266 at risk
EG00111 events10 affected265 at risk
EG0028 events7 affected266 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG00080 events79 affected266 at risk
EG00184 events84 affected265 at risk
EG00294 events92 affected266 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG00052 events40 affected266 at risk
EG00133 events21 affected265 at risk
EG00210 events10 affected266 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG00052 events37 affected266 at risk
EG00120 events16 affected265 at risk
EG00210 events10 affected266 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG00015 events13 affected266 at risk
EG00125 events16 affected265 at risk
EG0028 events7 affected266 at risk
EG003
Analysis of the China cohort was performed to evaluate the consistency of efficacy and safety in Chinese patients with the global cohort in order to meet regulatory requirements and was not powered for a formal assessment of statistical significance.
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
OG002
Global Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG000268
OG001268
OG002269
Title
Denominators
Categories
Title
Measurements
OG00010.4(9.6 to 12.0)
OG00112.9(11.3 to 14.7)
OG00210.5(9.3 to 11.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
D + EP vs EP. HR <1 favors D + EP to be associated with a longer OS than EP.
Log Rank
0.0032
Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.
Hazard Ratio (HR)
0.75
2-Sided
95
0.625
0.910
The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.
Superiority
OG000
OG002
D + T + EP vs EP. The alpha level applied at the global cohort final analysis was adjusted (using a generalized Haybittle-Peto method) to account for actual alpha spent at the interim analysis based on the actual final total number of events, and thus maintain control of overall Type I error. Boundary for declaring statistical significance was 0.0418 for a 5% overall alpha.
HR <1 favors D + T + EP to be associated with a longer OS than EP.
Log Rank
0.0451
Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.
Hazard Ratio (HR)
0.82
2-Sided
95
0.682
0.995
The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.
Superiority
OG001
China Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG00061
OG00162
Title
Denominators
Categories
Title
Measurements
OG00014.4(12.3 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
OG00110.9(8.9 to 14.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
D + EP vs EP. HR <1 favors D + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.
Log Rank
0.0664
Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.
Hazard Ratio (HR)
0.65
2-Sided
95
0.414
1.029
The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.
Other
OG001
China Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
OG002
China Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG00065
OG00161
OG00262
Title
Denominators
Categories
Title
Measurements
OG00016.1(11.3 to 18.6)
OG00114.4(12.3 to 17.0)
OG00210.9(8.9 to 14.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
D + EP vs EP. HR <1 favors D + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.
Log Rank
0.1455
Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.
Hazard Ratio (HR)
0.75
2-Sided
95
0.504
1.106
The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.
Other
OG000
OG002
D + T + EP vs EP. HR <1 favors D + T + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.
Log Rank
0.0314
Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.
Hazard Ratio (HR)
0.65
2-Sided
95
0.439
0.964
The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.
Other
OG001
Global Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG000268
OG001268
Title
Denominators
Categories
Title
Measurements
OG00010.4(9.6 to 12.0)
OG00112.9(11.3 to 14.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
D + T + EP vs D + EP. HR <1 favors D + T + EP to be associated with a longer OS than D + EP.
Log Rank
0.4352
Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.
Hazard Ratio (HR)
1.08
2-Sided
95
0.890
1.309
The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.
Superiority
OG001
Global Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
OG002
Global Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG000268
OG001268
OG002269
Title
Denominators
Categories
Title
Measurements
OG0004.9(4.7 to 5.9)
OG0015.1(4.7 to 6.2)
OG0025.4(4.8 to 6.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
D + EP vs EP. HR <1 favors D + EP to be associated with a longer PFS than EP.
Log Rank
0.0157
Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.
Hazard Ratio (HR)
0.80
2-Sided
95
0.665
0.959
The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.
Superiority
OG000
OG002
D + T + EP vs EP. HR <1 favors D + T + EP to be associated with a longer PFS than EP.
Log Rank
0.0568
Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.
Hazard Ratio (HR)
0.84
2-Sided
95
0.696
1.005
The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.
Superiority
OG000
OG001
D + T + EP vs D + EP. HR <1 favors D + T + EP to be associated with a longer PFS than D + EP.
Log Rank
0.7540
Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.
Hazard Ratio (HR)
1.03
2-Sided
95
0.857
1.235
The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.
Superiority
OG001
Global Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
OG002
Global Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG000267
OG001268
OG002269
Title
Denominators
Categories
Title
Measurements
OG00074.2
OG00179.5
OG00270.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
D + EP vs EP. An odds ratio >1 favors D + EP.
Regression, Logistic
0.0177
Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.
Odds Ratio (OR)
1.61
2-Sided
95
1.086
2.401
Superiority
OG000
OG002
D + T + EP vs EP. An odds ratio >1 favors D + T + EP.
Regression, Logistic
0.3611
Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.
Odds Ratio (OR)
1.19
2-Sided
95
0.817
1.746
Superiority
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
OG002
Global Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG000268
OG001268
OG002269
Title
Denominators
Categories
Title
Measurements
OG00043.2(37.1 to 49.1)
OG00145.4(39.3 to 51.3)
OG00245.8(39.5 to 51.9)
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
OG002
Global Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG000268
OG001268
OG002269
Title
Denominators
Categories
Title
Measurements
OG00016.9(12.6 to 21.7)
OG00117.9(13.5 to 22.8)
OG0025.3(2.9 to 8.8)
OG002
Global Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG000268
OG001268
OG002269
Title
Denominators
Categories
Title
Measurements
OG00030.7(25.2 to 36.4)
OG00132.0(26.5 to 37.7)
OG00224.8(19.7 to 30.1)
OG001
Global Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG000257
OG001261
Title
Denominators
Categories
Week 0: peak concentration
ParticipantsOG000239
ParticipantsOG001226
Title
Measurements
OG000447.3± 78.21
OG001502.6± 30.52
Week 3: trough concentration
ParticipantsOG000232
ParticipantsOG001237
Title
Measurements
OG00091.86± 74.36
OG001
Week 12: trough concentration
ParticipantsOG000173
ParticipantsOG001200
Title
Measurements
OG000199.2± 49.58
OG001
Units
Counts
Participants
OG000257
Title
Denominators
Categories
Week 0: peak concentration
ParticipantsOG000236
Title
Measurements
OG00022.77± 52.15
Week 3: trough concentration
ParticipantsOG000227
Title
Measurements
OG0004.245± 81.68
Week 12: trough concentration
ParticipantsOG000148
Title
Measurements
OG0007.576± 59.25
OG001
Global Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG000191
OG001205
Title
Denominators
Categories
ADA positive at any visit (ADA prevalence)
Title
Measurements
OG0006
OG00111
Treatment-emergent ADA positive (ADA incidence)
Title
Measurements
OG0000
OG0010
Treatment-boosted ADA
Title
Measurements
OG0000
OG0010
Treatment-induced ADA (ADA positive post-baseline only)
Title
Measurements
OG0000
OG0010
ADA positive at baseline only
Title
Measurements
OG0006
OG00111
ADA positive post-baseline and positive at baseline
Title
Measurements
OG0000
OG0010
Persistently positive
Title
Measurements
OG0000
OG0010
Transiently positive
Title
Measurements
OG0000
OG0010
nAb positive at any visit
Title
Measurements
OG0001
OG0010
Units
Counts
Participants
OG000178
Title
Denominators
Categories
ADA positive at any visit (ADA prevalence)
Title
Measurements
OG00011
Treatment-emergent ADA positive (ADA incidence)
Title
Measurements
OG0005
Treatment-boosted ADA
Title
Measurements
OG0000
Treatment-induced ADA (ADA positive post-baseline only)
Title
Measurements
OG0005
ADA positive at baseline only
Title
Measurements
OG0006
ADA positive post-baseline and positive at baseline
Title
Measurements
OG0000
Persistently positive
Title
Measurements
OG0004
Transiently positive
Title
Measurements
OG0001
nAb positive at any visit
Title
Measurements
OG0002
OG000
Global Cohort: D + T + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
OG001
Global Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
OG002
Global Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG000262
OG001261
OG002260
Title
Denominators
Categories
QLQ-C30 Global Health Status / HRQoL
ParticipantsOG000247
ParticipantsOG001239
ParticipantsOG002232
Title
Measurements
OG0007.2(5.8 to 8.3)
OG0018.4(7.3 to 11.0)
OG0027.4(6.5 to 9.3)
QLQ-C30 Cognitive Functioning
ParticipantsOG000251
ParticipantsOG001245
ParticipantsOG002242
Title
Measurements
OG000
QLQ-C30 Emotional Functioning
ParticipantsOG000248
ParticipantsOG001242
ParticipantsOG002240
Title
Measurements
OG000
QLQ-C30 Physical Functioning
ParticipantsOG000247
ParticipantsOG001244
ParticipantsOG002240
Title
Measurements
OG000
QLQ-C30 Role Functioning
ParticipantsOG000236
ParticipantsOG001231
ParticipantsOG002226
Title
Measurements
OG000
QLQ-C30 Social Functioning
ParticipantsOG000244
ParticipantsOG001237
ParticipantsOG002236
Title
Measurements
OG000
QLQ-C30 Fatigue
ParticipantsOG000242
ParticipantsOG001244
ParticipantsOG002232
Title
Measurements
OG000
QLQ-C30 Nausea / Vomiting
ParticipantsOG000252
ParticipantsOG001245
ParticipantsOG002244
Title
Measurements
OG000
QLQ-C30 Pain
ParticipantsOG000243
ParticipantsOG001240
ParticipantsOG002233
Title
Measurements
OG000
QLQ-C30 Appetite Loss
ParticipantsOG000236
ParticipantsOG001231
ParticipantsOG002224
Title
Measurements
OG000
QLQ-C30 Constipation
ParticipantsOG000243
ParticipantsOG001240
ParticipantsOG002229
Title
Measurements
OG000
QLQ-C30 Diarrhea
ParticipantsOG000250
ParticipantsOG001244
ParticipantsOG002244
Title
Measurements
OG000
QLQ-C30 Dyspnea
ParticipantsOG000227
ParticipantsOG001225
ParticipantsOG002218
Title
Measurements
OG000
QLQ-C30 Insomnia
ParticipantsOG000226
ParticipantsOG001226
ParticipantsOG002210
Title
Measurements
OG000
OG001
Global Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
OG002
Global Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG000262
OG001261
OG002260
Title
Denominators
Categories
QLQ-LC13 Coughing
ParticipantsOG000233
ParticipantsOG001230
ParticipantsOG002230
Title
Measurements
OG0007.7(6.9 to 10.8)
OG0019.3(8.0 to 14.1)
OG0027.7(6.7 to 9.5)
QLQ-LC13 Dyspnea
ParticipantsOG000249
ParticipantsOG001241
ParticipantsOG002240
Title
Measurements
OG000
QLQ-LC13 Hemoptysis
ParticipantsOG000252
ParticipantsOG001243
ParticipantsOG002245
Title
Measurements
OG000
QLQ-LC13 Pain in Arm or Shoulder
ParticipantsOG000245
ParticipantsOG001241
ParticipantsOG002238
Title
Measurements
OG000
QLQ-LC13 Pain in Chest
ParticipantsOG000243
ParticipantsOG001239
ParticipantsOG002240
Title
Measurements
OG000
QLQ-LC13 Pain in Other Parts
ParticipantsOG000245
ParticipantsOG001236
ParticipantsOG002231
Title
Measurements
OG000
OG001
Global Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG000262
OG001260
Title
Denominators
Categories
EORTC QLQ-LC13 Cough
ParticipantsOG000239
ParticipantsOG001232
Title
Measurements
OG000-15.1± 1.74
OG001-14.6± 1.76
EORTC QLQ-LC13 Dyspnea
ParticipantsOG000239
ParticipantsOG001232
Title
Measurements
OG000-6.8± 1.60
OG001
EORTC QLQ-LC13 Chest pain
ParticipantsOG000239
ParticipantsOG001232
Title
Measurements
OG000-7.4± 1.65
OG001
EORTC QLQ-C30 Fatigue
ParticipantsOG000239
ParticipantsOG001233
Title
Measurements
OG000-6.1± 1.84
OG001
EORTC QLQ-C30 Appetite loss
ParticipantsOG000239
ParticipantsOG001233
Title
Measurements
OG000-8.7± 2.02
OG001
OG001
Global Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG000261
OG001260
Title
Denominators
Categories
EORTC QLQ-LC13 Cough
ParticipantsOG000232
ParticipantsOG001232
Title
Measurements
OG000-15.0± 1.64
OG001-15.4± 1.72
EORTC QLQ-LC13 Dyspnea
ParticipantsOG000232
ParticipantsOG001232
Title
Measurements
OG000-7.1± 1.44
OG001
EORTC QLQ-LC13 Chest pain
ParticipantsOG000232
ParticipantsOG001232
Title
Measurements
OG000-7.8± 1.59
OG001
EORTC QLQ-C30 Fatigue
ParticipantsOG000233
ParticipantsOG001233
Title
Measurements
OG000-5.8± 1.62
OG001
EORTC QLQ-C30 Appetite loss
ParticipantsOG000233
ParticipantsOG001233
Title
Measurements
OG000-10.1± 1.73
OG001
OG001
China Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG00065
OG00161
Title
Denominators
Categories
Title
Measurements
OG00016.1(11.3 to 18.6)
OG00114.4(12.3 to 17.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
D + T + EP vs D + EP. HR <1 favors D + T + EP to be associated with a longer OS than D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.
Log Rank
0.4470
Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.
Hazard Ratio (HR)
0.86
2-Sided
95
0.574
1.277
The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.
Other
OG001
China Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
OG002
China Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG00065
OG00161
OG00262
Title
Denominators
Categories
Title
Measurements
OG0005.6(4.8 to 6.6)
OG0014.9(4.7 to 5.5)
OG0025.5(4.9 to 6.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
D + EP vs EP. HR <1 favors D + EP to be associated with a longer PFS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.
Log Rank
0.8934
Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.
Hazard Ratio (HR)
0.97
2-Sided
95
0.661
1.437
The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.
Other
OG000
OG002
D + T + EP vs EP. HR <1 favors D + T + EP to be associated with a longer PFS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.
Log Rank
0.1035
Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.
Hazard Ratio (HR)
0.72
2-Sided
95
0.487
1.068
The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.
Other
OG000
OG001
D + T + EP vs D + EP. HR <1 favors D + T + EP to be associated with a longer PFS than D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.
Log Rank
0.1673
Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.
Hazard Ratio (HR)
0.76
2-Sided
95
0.522
1.116
The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.
Other
OG001
China Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
OG002
China Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG00065
OG00161
OG00262
Title
Denominators
Categories
Title
Measurements
OG00084.6
OG00178.7
OG00272.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
D + EP vs EP. An odds ratio >1 favors D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.
Regression, Logistic
0.4320
Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.
Odds Ratio (OR)
1.39
2-Sided
95
0.610
3.244
Other
OG000
OG002
D + T + EP vs EP. An odds ratio >1 favors D + T + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.
Regression, Logistic
0.0986
Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.
Odds Ratio (OR)
2.07
2-Sided
95
0.874
5.118
Other
OG002
China Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG00065
OG00161
OG00262
Title
Denominators
Categories
Title
Measurements
OG00043.7(31.2 to 55.5)
OG00135.2(23.3 to 47.4)
OG00243.1(29.8 to 55.7)
OG002
China Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG00065
OG00161
OG00262
Title
Denominators
Categories
Title
Measurements
OG00021.0(12.0 to 31.9)
OG00112.3(5.4 to 22.2)
OG0026.2(1.6 to 15.3)
OG002
China Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG00065
OG00161
OG00262
Title
Denominators
Categories
Title
Measurements
OG00040.0(28.1 to 51.6)
OG00136.1(24.3 to 48.0)
OG00223.4(13.6 to 34.6)
OG001
China Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG00064
OG00159
Title
Denominators
Categories
Week 0: peak concentration
ParticipantsOG00064
ParticipantsOG00159
Title
Measurements
OG000429.4± 19.49
OG001432.0± 91.79
Week 3: trough concentration
ParticipantsOG00061
ParticipantsOG00154
Title
Measurements
OG00081.21± 46.14
OG001
Week 12: trough concentration
ParticipantsOG00046
ParticipantsOG00150
Title
Measurements
OG000151.0± 29.82
OG001
Units
Counts
Participants
OG00064
Title
Denominators
Categories
Week 0: peak concentration
ParticipantsOG00064
Title
Measurements
OG00024.34± 27.05
Week 3: trough concentration
ParticipantsOG00061
Title
Measurements
OG0004.530± 60.60
Week 12: trough concentration
ParticipantsOG00045
Title
Measurements
OG0009.523± 43.94
OG001
China Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG00053
OG00151
Title
Denominators
Categories
ADA positive at any visit (ADA prevalence)
Title
Measurements
OG0000
OG0010
Treatment-emergent ADA positive (ADA incidence)
Title
Measurements
OG0000
OG0010
Treatment-boosted ADA
Title
Measurements
OG0000
OG0010
Treatment-induced ADA (ADA positive post-baseline only)
Title
Measurements
OG0000
OG0010
ADA positive at baseline only
Title
Measurements
OG0000
OG0010
ADA positive post-baseline and positive at baseline
Title
Measurements
OG0000
OG0010
Persistently positive
Title
Measurements
OG0000
OG0010
Transiently positive
Title
Measurements
OG0000
OG0010
nAb positive at any visit
Title
Measurements
OG0000
OG0010
Units
Counts
Participants
OG00051
Title
Denominators
Categories
ADA positive at any visit (ADA prevalence)
Title
Measurements
OG0003
Treatment-emergent ADA positive (ADA incidence)
Title
Measurements
OG0003
Treatment-boosted ADA
Title
Measurements
OG0000
Treatment-induced ADA (ADA positive post-baseline only)
Title
Measurements
OG0003
ADA positive at baseline only
Title
Measurements
OG0000
ADA positive post-baseline and positive at baseline
Title
Measurements
OG0000
Persistently positive
Title
Measurements
OG0003
Transiently positive
Title
Measurements
OG0000
nAb positive at any visit
Title
Measurements
OG0000
During Chemotherapy:
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
OG001
China Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
OG002
China Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG00065
OG00161
OG00262
Title
Denominators
Categories
QLQ-C30 Global Health Status / HRQoL
ParticipantsOG00060
ParticipantsOG00157
ParticipantsOG00255
Title
Measurements
OG00014.5(6.8 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
OG00115.1(7.6 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
OG0027.8(6.5 to 10.9)
QLQ-C30 Cognitive Functioning
ParticipantsOG00060
ParticipantsOG00158
ParticipantsOG00258
Title
Measurements
OG000
QLQ-C30 Emotional Functioning
ParticipantsOG00060
ParticipantsOG00158
ParticipantsOG00258
Title
Measurements
OG000
QLQ-C30 Physical Functioning
ParticipantsOG00060
ParticipantsOG00158
ParticipantsOG00258
Title
Measurements
OG000
QLQ-C30 Role Functioning
ParticipantsOG00060
ParticipantsOG00156
ParticipantsOG00257
Title
Measurements
OG000
QLQ-C30 Social Functioning
ParticipantsOG00060
ParticipantsOG00157
ParticipantsOG00256
Title
Measurements
OG000
QLQ-C30 Fatigue
ParticipantsOG00060
ParticipantsOG00158
ParticipantsOG00258
Title
Measurements
OG000
QLQ-C30 Nausea / Vomiting
ParticipantsOG00059
ParticipantsOG00158
ParticipantsOG00258
Title
Measurements
OG000
QLQ-C30 Pain
ParticipantsOG00060
ParticipantsOG00157
ParticipantsOG00258
Title
Measurements
OG000
QLQ-C30 Appetite Loss
ParticipantsOG00059
ParticipantsOG00157
ParticipantsOG00257
Title
Measurements
OG000
QLQ-C30 Constipation
ParticipantsOG00059
ParticipantsOG00158
ParticipantsOG00258
Title
Measurements
OG000
QLQ-C30 Diarrhea
ParticipantsOG00059
ParticipantsOG00158
ParticipantsOG00258
Title
Measurements
OG000
QLQ-C30 Dyspnea
ParticipantsOG00060
ParticipantsOG00157
ParticipantsOG00256
Title
Measurements
OG000
QLQ-C30 Insomnia
ParticipantsOG00060
ParticipantsOG00157
ParticipantsOG00258
Title
Measurements
OG000
OG001
China Cohort: D + EP
During Chemotherapy:
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).
Post-Chemotherapy:
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
OG002
China Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG00065
OG00161
OG00262
Title
Denominators
Categories
QLQ-LC13 Coughing
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00254
Title
Measurements
OG000NA(6.8 to NA)Median and upper limit of 95% CI could not be calculated as they were not reached.
OG00115.5(5.8 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
OG0028.6(6.8 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
QLQ-LC13 Dyspnea
ParticipantsOG00060
ParticipantsOG00158
ParticipantsOG00258
Title
Measurements
OG000
QLQ-LC13 Hemoptysis
ParticipantsOG00060
ParticipantsOG00158
ParticipantsOG00258
Title
Measurements
OG000
QLQ-LC13 Pain in Arm or Shoulder
ParticipantsOG00060
ParticipantsOG00155
ParticipantsOG00258
Title
Measurements
OG000
QLQ-LC13 Pain in Chest
ParticipantsOG00059
ParticipantsOG00155
ParticipantsOG00257
Title
Measurements
OG000
QLQ-LC13 Pain in Other Parts
ParticipantsOG00060
ParticipantsOG00158
ParticipantsOG00257
Title
Measurements
OG000
OG001
China Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG00065
OG00162
Title
Denominators
Categories
EORTC QLQ-LC13 Cough
ParticipantsOG00060
ParticipantsOG00156
Title
Measurements
OG000-12.8± 2.49
OG001-12.9± 2.50
EORTC QLQ-LC13 Dyspnea
ParticipantsOG00060
ParticipantsOG00156
Title
Measurements
OG000-3.6± 2.21
OG001
EORTC QLQ-LC13 Chest pain
ParticipantsOG00060
ParticipantsOG00156
Title
Measurements
OG000-5.1± 2.16
OG001
EORTC QLQ-C30 Fatigue
ParticipantsOG00060
ParticipantsOG00156
Title
Measurements
OG0002.8± 2.10
OG001
EORTC QLQ-C30 Appetite loss
ParticipantsOG00060
ParticipantsOG00156
Title
Measurements
OG0003.0± 2.36
OG001
OG001
China Cohort: EP
For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
Units
Counts
Participants
OG00061
OG00162
Title
Denominators
Categories
EORTC QLQ-LC13 Cough
ParticipantsOG00058
ParticipantsOG00156
Title
Measurements
OG000-14.9± 2.66
OG001-16.7± 2.68
EORTC QLQ-LC13 Dyspnea
ParticipantsOG00058
ParticipantsOG00156
Title
Measurements
OG000-2.2± 1.93
OG001
EORTC QLQ-LC13 Chest pain
ParticipantsOG00058
ParticipantsOG00156
Title
Measurements
OG000-6.7± 1.93
OG001
EORTC QLQ-C30 Fatigue
ParticipantsOG00058
ParticipantsOG00156
Title
Measurements
OG0001.5± 2.06
OG001
EORTC QLQ-C30 Appetite loss
ParticipantsOG00058
ParticipantsOG00156
Title
Measurements
OG0003.6± 2.47
OG001
5 events
5 affected
65 at risk
EG0046 events6 affected61 at risk
EG00511 events7 affected62 at risk
3 events
2 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0052 events2 affected62 at risk
0 events
0 affected
65 at risk
EG0041 events1 affected61 at risk
EG0053 events3 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
3 events
3 affected
65 at risk
EG0040 events0 affected61 at risk
EG0051 events1 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0042 events2 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0051 events1 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
2 events
1 affected
65 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0041 events1 affected61 at risk
EG0051 events1 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0052 events2 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0042 events2 affected61 at risk
EG0052 events2 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0051 events1 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
2 events
2 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0042 events2 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0051 events1 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0051 events1 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
9 events
9 affected
65 at risk
EG0045 events5 affected61 at risk
EG0052 events2 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0051 events1 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0051 events1 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0041 events1 affected61 at risk
EG0051 events1 affected62 at risk
2 events
2 affected
65 at risk
EG0040 events0 affected61 at risk
EG0052 events1 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0042 events2 affected61 at risk
EG0051 events1 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0051 events1 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0052 events2 affected62 at risk
1 events
1 affected
65 at risk
EG0042 events2 affected61 at risk
EG0052 events2 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0042 events2 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0051 events1 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
2 events
2 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected62 at risk
1 events
1 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0051 events1 affected62 at risk
11 events
10 affected
65 at risk
EG0048 events6 affected61 at risk
EG0057 events7 affected62 at risk
79 events
47 affected
65 at risk
EG00458 events44 affected61 at risk
EG00562 events44 affected62 at risk
6 events
5 affected
65 at risk
EG0049 events4 affected61 at risk
EG00512 events4 affected62 at risk
5 events
5 affected
65 at risk
EG0042 events2 affected61 at risk
EG0054 events4 affected62 at risk
73 events
28 affected
65 at risk
EG00465 events31 affected61 at risk
EG00569 events22 affected62 at risk
11 events
6 affected
65 at risk
EG0041 events1 affected61 at risk
EG0053 events2 affected62 at risk
50 events
26 affected
65 at risk
EG00440 events22 affected61 at risk
EG00555 events19 affected62 at risk
28 events
15 affected
65 at risk
EG00425 events13 affected61 at risk
EG00523 events14 affected62 at risk
11 events
11 affected
65 at risk
EG0048 events7 affected61 at risk
EG0051 events1 affected62 at risk
14 events
13 affected
65 at risk
EG0047 events7 affected61 at risk
EG0051 events1 affected62 at risk
4 events
4 affected
65 at risk
EG0049 events7 affected61 at risk
EG0050 events0 affected62 at risk
39 events
25 affected
65 at risk
EG00429 events24 affected61 at risk
EG00529 events22 affected62 at risk
6 events
4 affected
65 at risk
EG0042 events2 affected61 at risk
EG0051 events1 affected62 at risk
72 events
31 affected
65 at risk
EG00451 events20 affected61 at risk
EG00559 events27 affected62 at risk
2 events
2 affected
65 at risk
EG0040 events0 affected61 at risk
EG0051 events1 affected62 at risk
62 events
30 affected
65 at risk
EG00435 events19 affected61 at risk
EG00557 events23 affected62 at risk
7 events
6 affected
65 at risk
EG0047 events7 affected61 at risk
EG0058 events6 affected62 at risk
7 events
7 affected
65 at risk
EG0047 events6 affected61 at risk
EG0056 events4 affected62 at risk
3 events
2 affected
65 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected62 at risk
7 events
3 affected
65 at risk
EG0041 events1 affected61 at risk
EG0050 events0 affected62 at risk
33 events
23 affected
65 at risk
EG0049 events6 affected61 at risk
EG0058 events5 affected62 at risk
12 events
10 affected
65 at risk
EG0048 events4 affected61 at risk
EG0053 events2 affected62 at risk
8 events
7 affected
65 at risk
EG0042 events2 affected61 at risk
EG0053 events3 affected62 at risk
7 events
5 affected
65 at risk
EG0044 events3 affected61 at risk
EG0055 events5 affected62 at risk
19 events
12 affected
65 at risk
EG0043 events2 affected61 at risk
EG0053 events3 affected62 at risk
5 events
4 affected
65 at risk
EG0047 events4 affected61 at risk
EG0054 events3 affected62 at risk
24 events
17 affected
65 at risk
EG0046 events6 affected61 at risk
EG00510 events6 affected62 at risk
5 events
4 affected
65 at risk
EG0048 events4 affected61 at risk
EG0050 events0 affected62 at risk
12 events
11 affected
65 at risk
EG00413 events11 affected61 at risk
EG0057 events5 affected62 at risk
3 events
2 affected
65 at risk
EG0042 events2 affected61 at risk
EG0054 events4 affected62 at risk
12 events
7 affected
65 at risk
EG0044 events3 affected61 at risk
EG0056 events3 affected62 at risk
9 events
6 affected
65 at risk
EG0049 events5 affected61 at risk
EG0058 events5 affected62 at risk
3 events
2 affected
65 at risk
EG0043 events1 affected61 at risk
EG00510 events5 affected62 at risk
3 events
2 affected
65 at risk
EG0042 events2 affected61 at risk
EG0058 events4 affected62 at risk
1 events
1 affected
65 at risk
EG0043 events3 affected61 at risk
EG0055 events5 affected62 at risk
6 events
4 affected
65 at risk
EG0043 events2 affected61 at risk
EG0053 events3 affected62 at risk
3 events
2 affected
65 at risk
EG0042 events2 affected61 at risk
EG0054 events4 affected62 at risk
4 events
4 affected
65 at risk
EG0047 events4 affected61 at risk
EG0058 events3 affected62 at risk
52 events
22 affected
65 at risk
EG00444 events28 affected61 at risk
EG00571 events21 affected62 at risk
15 events
10 affected
65 at risk
EG00411 events10 affected61 at risk
EG00517 events11 affected62 at risk
8 events
7 affected
65 at risk
EG00412 events10 affected61 at risk
EG0056 events5 affected62 at risk
34 events
16 affected
65 at risk
EG00427 events17 affected61 at risk
EG00554 events24 affected62 at risk
40 events
27 affected
65 at risk
EG00446 events27 affected61 at risk
EG00554 events27 affected62 at risk
1 events
1 affected
65 at risk
EG0045 events4 affected61 at risk
EG0055 events3 affected62 at risk
5 events
2 affected
65 at risk
EG0045 events4 affected61 at risk
EG0050 events0 affected62 at risk
6 events
4 affected
65 at risk
EG00410 events3 affected61 at risk
EG00514 events6 affected62 at risk
7 events
7 affected
65 at risk
EG0044 events3 affected61 at risk
EG0056 events4 affected62 at risk
2 events
2 affected
65 at risk
EG0042 events2 affected61 at risk
EG0056 events4 affected62 at risk
9 events
5 affected
65 at risk
EG0046 events5 affected61 at risk
EG0056 events3 affected62 at risk
18 events
9 affected
65 at risk
EG00412 events9 affected61 at risk
EG00518 events12 affected62 at risk
5 events
4 affected
65 at risk
EG0041 events1 affected61 at risk
EG0054 events2 affected62 at risk
28 events
18 affected
65 at risk
EG00413 events10 affected61 at risk
EG00520 events16 affected62 at risk
5 events
3 affected
65 at risk
EG0046 events5 affected61 at risk
EG0059 events5 affected62 at risk
4 events
3 affected
65 at risk
EG0044 events3 affected61 at risk
EG0056 events5 affected62 at risk
1 events
1 affected
65 at risk
EG0044 events4 affected61 at risk
EG0050 events0 affected62 at risk
2 events
2 affected
65 at risk
EG0044 events4 affected61 at risk
EG0050 events0 affected62 at risk
7 events
6 affected
65 at risk
EG0048 events6 affected61 at risk
EG0057 events5 affected62 at risk
4 events
4 affected
65 at risk
EG0046 events4 affected61 at risk
EG0053 events2 affected62 at risk
0 events
0 affected
65 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected62 at risk
8 events
6 affected
65 at risk
EG0048 events6 affected61 at risk
EG00513 events8 affected62 at risk
22 events
14 affected
65 at risk
EG00414 events9 affected61 at risk
EG00514 events10 affected62 at risk
13 events
11 affected
65 at risk
EG0048 events8 affected61 at risk
EG0055 events5 affected62 at risk
5 events
3 affected
65 at risk
EG0044 events4 affected61 at risk
EG0055 events4 affected62 at risk
2 events
2 affected
65 at risk
EG0047 events7 affected61 at risk
EG0052 events2 affected62 at risk
6 events
5 affected
65 at risk
EG0044 events4 affected61 at risk
EG0051 events1 affected62 at risk
4 events
4 affected
65 at risk
EG0040 events0 affected61 at risk
EG0052 events2 affected62 at risk
11 events
9 affected
65 at risk
EG0047 events6 affected61 at risk
EG0053 events3 affected62 at risk
29 events
28 affected
65 at risk
EG00429 events29 affected61 at risk
EG00527 events27 affected62 at risk
14 events
4 affected
65 at risk
EG0043 events2 affected61 at risk
EG0051 events1 affected62 at risk
37 events
25 affected
65 at risk
EG00416 events12 affected61 at risk
EG0052 events2 affected62 at risk
13 events
6 affected
65 at risk
EG00412 events7 affected61 at risk
EG0058 events3 affected62 at risk
46
≥50 to <65
BG000138
BG001157
BG002137
BG003432
≥65 to <75
BG00091
BG00182
BG00290
BG003263
≥75
BG00023
BG00119
BG00222
BG00364
16
≥50 to <65
BG00040
BG00139
BG00233
BG003112
≥65 to <75
BG00017
BG00116
BG00220
BG00353
≥75
BG0003
BG0013
BG0021
BG0037
229
Male
BG000202
BG001190
BG002184
BG003576
27
Male
BG00057
BG00152
BG00252
BG003161
23
Not Hispanic or Latino
BG000260
BG001255
BG002261
BG003776
Unknown or Not Reported
BG0001
BG0013
BG0022
BG0036
0
Not Hispanic or Latino
BG00065
BG00161
BG00262
BG003188
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
665
Black or African American
BG0001
BG0012
BG0023
BG0036
Asian
BG00047
BG00136
BG00242
BG003125
Other
BG0005
BG0011
BG0022
BG0038
Missing
BG0000
BG0010
BG0021
BG0031
0
Black or African American
BG0000
BG0010
BG0020
BG0030
Asian
BG00065
BG00161
BG00262
BG003188
Other
BG0000
BG0010
BG0020
BG0030
Missing
BG0000
BG0010
BG0020
BG0030
109.5
± 64.55
239.3
± 50.68
6.0
(5.0 to 7.0)
OG0018.4(7.3 to 10.3)
OG0026.0(5.2 to 7.1)
7.6
(6.6 to 9.5)
OG00111.8(8.6 to 16.6)
OG0027.3(6.7 to 8.3)
6.0
(5.0 to 6.9)
OG0018.4(7.4 to 12.0)
OG0026.5(6.0 to 8.2)
5.0
(4.1 to 6.5)
OG0017.4(5.7 to 10.2)
OG0025.9(4.5 to 6.7)
6.2
(5.0 to 7.4)
OG0017.4(6.5 to 8.8)
OG0026.3(4.9 to 7.4)
4.2
(3.1 to 4.7)
OG0015.5(4.0 to 6.6)
OG0024.5(3.5 to 5.3)
7.5
(6.1 to 8.6)
OG0018.4(6.6 to 10.2)
OG0026.6(5.6 to 7.5)
6.9
(6.0 to 7.7)
OG0018.0(6.8 to 10.4)
OG0026.7(6.2 to 7.8)
6.9
(5.6 to 8.5)
OG0018.3(6.8 to 11.0)
OG0026.6(5.5 to 7.5)
8.5
(7.1 to 10.8)
OG00111.5(8.3 to 14.7)
OG0027.3(6.2 to 9.0)
8.9
(7.5 to 10.8)
OG00114.7(9.4 to 21.1)
OG0027.7(7.1 to 9.5)
7.2
(5.6 to 8.3)
OG0019.0(7.6 to 12.7)
OG0027.5(6.6 to 9.0)
7.1
(6.1 to 8.6)
OG0018.6(7.1 to 11.8)
OG0027.3(6.4 to 8.3)
6.3
(4.9 to 7.4)
OG0016.5(5.5 to 7.8)
OG0025.5(4.6 to 7.2)
11.4
(8.9 to 18.6)
OG00118.3(14.5 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
OG00210.8(8.4 to 11.9)
7.1
(6.3 to 8.3)
OG0019.7(8.1 to 15.1)
OG0027.6(6.6 to 9.3)
8.5
(7.2 to 10.8)
OG00111.5(8.4 to 15.8)
OG0027.9(7.2 to 9.9)
7.4
(6.5 to 8.7)
OG0017.8(6.6 to 9.3)
OG0026.6(5.1 to 7.5)
-6.6
± 1.62
-7.0
± 1.67
-6.3
± 1.86
-9.5
± 2.05
-6.5
± 1.50
-7.2
± 1.65
-4.5
± 1.69
-7.6
± 1.81
96.24
± 64.44
194.4
± 53.34
7.6
(4.9 to NA)
Upper limit of 95% CI could not be calculated as it was not reached.
OG0016.8(2.3 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
OG0026.9(5.7 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
20.4
(6.8 to NA)
Upper limit of 95% CI could not be calculated as it was not reached.
OG00115.5(5.8 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
OG00210.0(6.9 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
21.8
(6.0 to NA)
Upper limit of 95% CI could not be calculated as it was not reached.
OG0019.3(5.8 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
OG0027.3(5.7 to 10.9)
6.8
(4.9 to 21.3)
OG0016.4(4.2 to 13.9)
OG0026.2(4.1 to 10.0)
6.7
(4.3 to 14.1)
OG0015.8(3.9 to 13.3)
OG0026.5(3.3 to 8.3)
3.7
(2.3 to 6.8)
OG0015.3(2.9 to 9.6)
OG0023.9(2.2 to 5.9)
8.4
(4.7 to NA)
Upper limit of 95% CI could not be calculated as it was not reached.
OG0019.3(3.9 to 15.5)
OG0028.2(5.7 to 10.9)
6.6
(4.9 to 17.3)
OG0016.2(5.5 to 15.1)
OG0026.5(4.6 to 8.6)
8.4
(2.6 to NA)
Upper limit of 95% CI could not be calculated as it was not reached.
OG0015.8(3.3 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
OG0026.9(5.7 to 10.0)
NA
(6.8 to NA)
Median and upper limit of 95% CI could not be calculated as they were not reached.
OG00112.0(5.8 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
OG00210.9(8.6 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
17.3
(9.8 to NA)
Upper limit of 95% CI could not be calculated as it was not reached.
OG001NA(13.3 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
OG00210.1(8.2 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
11.6
(6.0 to NA)
Upper limit of 95% CI could not be calculated as it was not reached.
OG00115.5(9.3 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
OG0027.3(5.7 to 10.9)
7.3
(5.2 to NA)
Upper limit of 95% CI could not be calculated as it was not reached.
OG00115.5(5.6 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
OG0027.8(6.3 to 10.9)
6.9
(3.4 to NA)
Upper limit of 95% CI could not be calculated as it was not reached.
OG0018.1(5.3 to 15.5)
OG0024.7(2.5 to 8.6)
NA
(17.3 to NA)
Median and upper limit of 95% CI could not be calculated as they were not reached.
OG001NA(11.2 to NA)Median and upper limit of 95% CI could not be calculated as they were not reached.
OG00210.1(6.9 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
NA
(6.9 to NA)
Median and upper limit of 95% CI could not be calculated as they were not reached.
OG00115.5(5.6 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
OG0028.6(6.3 to 10.9)
NA
(6.8 to NA)
Median and upper limit of 95% CI could not be calculated as they were not reached.
OG00115.5(6.8 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
OG00210.0(6.9 to NA)Upper limit of 95% CI could not be calculated as it was not reached.
NA
(7.0 to NA)
Median and upper limit of 95% CI could not be calculated as they were not reached.
OG0019.3(6.2 to NA)Upper limit of 95% CI could not be calculated as it was not reached.