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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001633-24 | EudraCT Number |
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A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Stage IV Urothelial Cancer
This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of MEDI4736 (Durvalumab) monotherapy and MEDI4736 (Durvalumab) in combination with tremelimumab versus SoC (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) first-line chemotherapy in treatment-naïve patients with histologically or cytologically documented, unresectable, Stage IV transitional cell carcinoma (transitional cell and mixed transitional/non-transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra) and to allow sufficient flexibility for Investigators and patients to select the agents that reflect their normal clinical practice and national guidelines. The patients enrolled in the study will be randomized 1:1:1 to receive treatment with combination therapy, monotherapy, or SoC (cisplatin + gemcitabine or carboplatin + gemcitabine, based on cisplatin eligibility). Patients will be treated with MEDI4736 (Durvalumab) or MEDI4736 (Durvalumab) with tremelimumab, or treated with SoC until progressive disease (PD) is confirmed, unacceptable toxicity occurs, withdrawal of consent, or another discontinuation criterion is met. Patients will be followed for up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Therapy | Experimental | MEDI4736 (Durvalumab) + Tremelimumab |
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| Monotherapy | Experimental | MEDI4736 (Durvalumab) |
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| Standard of Care | Active Comparator | Standard of Care Chemotherapy Treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI4736 (Durvalumab) | Drug | IV infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set | The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. | From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set | The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. | From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| Measure | Description | Time Frame |
|---|---|---|
| OS, Full Analysis Set - Durvalumab Monotherapy vs SoC | The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Los Angeles | California | 90095 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32971005 | Derived | Powles T, van der Heijden MS, Castellano D, Galsky MD, Loriot Y, Petrylak DP, Ogawa O, Park SH, Lee JL, De Giorgi U, Bogemann M, Bamias A, Eigl BJ, Gurney H, Mukherjee SD, Fradet Y, Skoneczna I, Tsiatas M, Novikov A, Suarez C, Fay AP, Duran I, Necchi A, Wildsmith S, He P, Angra N, Gupta AK, Levin W, Bellmunt J; DANUBE study investigators. Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1574-1588. doi: 10.1016/S1470-2045(20)30541-6. Epub 2020 Sep 21. |
| Label | URL |
|---|---|
| Redacted SAP | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Combination Therapy | MEDI4736 (Durvalumab) + Tremelimumab |
| FG001 | Monotherapy | MEDI4736 (Durvalumab) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 3, 2019 | Jan 25, 2021 |
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| Tremelimumab |
| Drug |
IV infusion |
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| Cisplatin | Drug | IV infusion |
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| Carboplatin | Drug | IV infusion |
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| Gemcitabine | Drug | IV infusion |
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| From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| OS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC | The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. | From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| OS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy | The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. | From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| Alive at 24 Months (OS24), Full Analysis Set | Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months. | From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020). |
| Alive at 24 Months (OS24), PD-L1-High Analysis Set | Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months. | From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020). |
| Alive at 24 Months (OS24), PD-L1-Low/Negative Analysis Set | Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months. | From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020). |
| PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | Progression free survival (PFS) (per RECIST 1.1, as assessed by investigator) was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| PFS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC | Progression free survival (PFS) (per RECIST 1.1, as assessed by investigator) was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| PFS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy | Progression free survival (PFS) (per RECIST 1.1, as assessed by investigator) was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| Alive and Progression-free at 12 Months (APF12), Full Analysis Set | Alive and progression-free at 12 months (APF12) was defined as the Kaplan-Meier estimate of PFS (per RECIST 1.1 as assessed by investigator) at 12 months. | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020). |
| Alive and Progression-free at 12 Months (APF12), PD-L1-High Analysis Set | Alive and progression-free at 12 months (APF12) was defined as the Kaplan-Meier estimate of PFS (per RECIST 1.1 as assessed by investigator) at 12 months. | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020). |
| Alive and Progression-free at 12 Months (APF12), PD-L1-Low/Negative Analysis Set | Alive and progression-free at 12 months (APF12) was defined as the Kaplan-Meier estimate of PFS (per RECIST 1.1 as assessed by investigator) at 12 months. | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020). |
| PFS2, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1). Median PFS2 was calculated using the Kaplan-Meier technique. | Tumour scans performed at baseline then every 8 weeks since randomization until first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| PFS2, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC | Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1). Median PFS2 was calculated using the Kaplan-Meier technique. | Tumour scans performed at baseline then every 8 weeks since randomization until first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| PFS2, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy | Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1). Median PFS2 was calculated using the Kaplan-Meier technique. | Tumour scans performed at baseline then every 8 weeks since randomization until first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| Objective Response Rate (ORR), Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR. | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| Objective Response Rate (ORR), PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC | Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR. | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| Objective Response Rate (ORR), PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy | Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR. | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| Objective Response Rate (ORR) Based on BICR Assessment According to RECIST 1.1 - Responses Are Confirmed - Durvalumab Cisplatin Ineligible Population | Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR. unconfirmed responses are excluded. | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (01NOV2017, a maximum of 3 years). |
| Disease Control Rate (DCR) at 6 Months, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | Disease control rate (DCR) at 6 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 24 weeks (-7 days, i.e., 161 days), following the start of study treatment. | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 6 months or the data cut-off date (27JAN2020). |
| Disease Control Rate (DCR) at 6 Months, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC | Disease control rate (DCR) at 6 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 24 weeks (-7 days, i.e., 161 days), following the start of study treatment. | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 6 months or the data cut-off date (27JAN2020). |
| Disease Control Rate (DCR) at 6 Months, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy | Disease control rate (DCR) at 6 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 24 weeks (-7 days, i.e., 161 days), following the start of study treatment. | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 6 months or the data cut-off date (27JAN2020). |
| Disease Control Rate (DCR) at 12 Months, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | Disease control rate (DCR) at 12 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 48 weeks (-7 days, i.e., 329 days), following the start of study treatment. | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020) |
| Disease Control Rate (DCR) at 12 Months, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC | Disease control rate (DCR) at 12 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 48 weeks (-7 days, i.e., 329 days), following the start of study treatment. | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020). |
| Disease Control Rate (DCR) at 12 Months, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy | Disease control rate (DCR) at 12 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 48 weeks (-7 days, i.e., 329 days), following the start of study treatment. | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020). |
| Duration of Response (DoR), Full Analysis Set | Duration of response (DoR) (per RECIST 1.1 as assessed by investigator) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| Duration of Response (DoR), PD-L1-High Analysis Set | Duration of response (DoR) (per RECIST 1.1 as assessed by investigator) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| Duration of Response (DoR), PD-L1-Low/Negative Analysis Set | Duration of response (DoR) (per RECIST 1.1 as assessed by investigator) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| Serum Concentrations of Durvalumab, Pharmacokinetic Analysis Set | Blood samples were collected to determine the serum concentration of durvalumab. | Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, pre-dose at week 4, and at follow-up Month 3. |
| Serum Concentrations of Tremelimumab, Pharmacokinetic Analysis Set | Blood samples were collected to determine the serum concentration of tremelimumab. | Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, pre-dose at week 4, and at follow-up Month 3. |
| Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab, Safety Analysis Set - ADA Evaluable Patients | Serum Samples will be measured for the presence of ADAs and ADA-neutralizing antibodies for Durvalumab using validated assays. Tiered analysis will be performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples will be used. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The category may include patients meeting these criteria who are ADA positive at baseline. | At week 0, 4, 12 and 24, and at follow-up Month 3. |
| Number of Participants With Anti-Drug Antibody (ADA) Response to Tremelimumab, Safety Analysis Set - ADA Evaluable Patients | Serum Samples will be measured for the presence of ADAs and ADA-neutralizing antibodies for Tremelimumab using validated assays. Tiered analysis will be performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples will be used. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The category may include patients meeting these criteria who are ADA positive at baseline. | At week 0, 4, 12 and at follow-up Month 3. |
| Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score. All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104). NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items "I feel weak all overall" and "I feel light-headed (dizzy)". The range of each item is 0-4. Higher score represent worse outcome. | At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score. All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104). NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items "I feel weak all overall" and "I feel light-headed (dizzy)". The range of each item is 0-4. Higher score represent worse | At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score. All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104). NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items "I feel weak all overall" and "I feel light-headed (dizzy)". The range of each item is 0-4. Higher score represent worse | At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| Improvement in Fatigue and Deterioration in Pain Per FACT-BL, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | Fatigue will be based on the question of "I have a lack of energy" and pain will be based on the question of "I have pain", according to GP1 and GP4 in PWB, respectively. Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL. Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL. | At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | Fatigue will be based on the question of "I have a lack of energy" and pain will be based on the question of "I have pain", according to GP1 and GP4 in PWB, respectively. Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL. Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL. | At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | Fatigue will be based on the question of "I have a lack of energy" and pain will be based on the question of "I have pain", according to GP1 and GP4 in PWB, respectively. Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL. Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL. | At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
| Stanford |
| California |
| 94305 |
| United States |
| Research Site | Aurora | Colorado | 80045 | United States |
| Research Site | New Haven | Connecticut | 06520 | United States |
| Research Site | Tampa | Florida | 33612 | United States |
| Research Site | Atlanta | Georgia | 30322 | United States |
| Research Site | Louisville | Kentucky | 40202 | United States |
| Research Site | Boston | Massachusetts | 02215 | United States |
| Research Site | Ann Arbor | Michigan | 48109 | United States |
| Research Site | Detroit | Michigan | 48201 | United States |
| Research Site | Omaha | Nebraska | 68130 | United States |
| Research Site | New York | New York | 10021 | United States |
| Research Site | New York | New York | 10029 | United States |
| Research Site | Memphis | Tennessee | 38120 | United States |
| Research Site | Nashville | Tennessee | 37203 | United States |
| Research Site | Seattle | Washington | 98101 | United States |
| Research Site | Box Hill | 3128 | Australia |
| Research Site | Elizabeth Vale | 5112 | Australia |
| Research Site | Macquarie University | 2109 | Australia |
| Research Site | St Leonards | 2065 | Australia |
| Research Site | Waratah | 2298 | Australia |
| Research Site | Linz | 4010 | Austria |
| Research Site | Vienna | 1090 | Austria |
| Research Site | Vienna | 1140 | Austria |
| Research Site | Brussels | 1000 | Belgium |
| Research Site | Brussels | 1200 | Belgium |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Liège | 4000 | Belgium |
| Research Site | Barretos | 14784-400 | Brazil |
| Research Site | Belo Horizonte | 30380-472 | Brazil |
| Research Site | Ijuí | 98700-000 | Brazil |
| Research Site | Itajaí | 88301-220 | Brazil |
| Research Site | Porto Alegre | 90035-003 | Brazil |
| Research Site | Porto Alegre | 90610-000 | Brazil |
| Research Site | Porto Alegre | 91350-200 | Brazil |
| Research Site | Rio de Janeiro | 20231-050 | Brazil |
| Research Site | Rio de Janeiro | 22793-080 | Brazil |
| Research Site | São José do Rio Preto | 15090-000 | Brazil |
| Research Site | São Paulo | 01209-000 | Brazil |
| Research Site | São Paulo | 01321-001 | Brazil |
| Research Site | São Paulo | 01509-900 | Brazil |
| Research Site | Calgary | Alberta | T2N 4N2 | Canada |
| Research Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Research Site | Kelowna | British Columbia | V1Y 5L3 | Canada |
| Research Site | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Research Site | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Research Site | Hamilton | Ontario | L8V 5C2 | Canada |
| Research Site | Newmarket | Ontario | L3Y 2P9 | Canada |
| Research Site | Oshawa | Ontario | L1G 2B9 | Canada |
| Research Site | Ottawa | Ontario | K1H 1C4 | Canada |
| Research Site | Toronto | Ontario | M4N 3M5 | Canada |
| Research Site | Toronto | Ontario | M5G 2M9 | Canada |
| Research Site | Québec | Quebec | G1R 3S1 | Canada |
| Research Site | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Research Site | Beijing | 100034 | China |
| Research Site | Beijing | 100039 | China |
| Research Site | Beijing | 100191 | China |
| Research Site | Changchun | 130012 | China |
| Research Site | Changsha | 410013 | China |
| Research Site | Chongqing | 400038 | China |
| Research Site | Hangzhou | 310009 | China |
| Research Site | Hangzhou | 310014 | China |
| Research Site | Nanjing | 210008 | China |
| Research Site | Shanghai | 200000 | China |
| Research Site | Shanghai | 200032 | China |
| Research Site | Shanghai | 200072 | China |
| Research Site | Shanghai | 200080 | China |
| Research Site | Shanghai | 200127 | China |
| Research Site | Shenyang | 110001 | China |
| Research Site | Tianjin | 300211 | China |
| Research Site | Xi'an | 710061 | China |
| Research Site | Xiamen | 361003 | China |
| Research Site | Århus C | 8000 | Denmark |
| Research Site | Herlev | 2730 | Denmark |
| Research Site | København Ø | 2100 | Denmark |
| Research Site | Odense C | 5000 | Denmark |
| Research Site | Bordeaux | 33000 | France |
| Research Site | Bordeaux | 33076 | France |
| Research Site | Caen | 14076 | France |
| Research Site | Lyon | 69008 | France |
| Research Site | Marseille | 13273 | France |
| Research Site | Paris | 75475 | France |
| Research Site | Poitiers | 86021 | France |
| Research Site | Suresnes | 92151 | France |
| Research Site | Toulouse | 31059 | France |
| Research Site | Villejuif | 94805 | France |
| Research Site | Düsseldorf | 40225 | Germany |
| Research Site | Erlangen | 91054 | Germany |
| Research Site | Hanover | 30625 | Germany |
| Research Site | Heidelberg | 69120 | Germany |
| Research Site | Jena | 07747 | Germany |
| Research Site | München | 81675 | Germany |
| Research Site | Münster | 48149 | Germany |
| Research Site | Athens | 11528 | Greece |
| Research Site | Athens | 14564 | Greece |
| Research Site | Heraklion | 71110 | Greece |
| Research Site | Holargos, Athens | 155 62 | Greece |
| Research Site | Maroussi, Athens | 15125 | Greece |
| Research Site | Pátrai | 26500 | Greece |
| Research Site | Thessaloniki | 56 429 | Greece |
| Research Site | Haifa | 31096 | Israel |
| Research Site | Jerusalem | 91120 | Israel |
| Research Site | Petah Tikva | 4941492 | Israel |
| Research Site | Ramat Gan | 5265601 | Israel |
| Research Site | Ẕerifin | 70300 | Israel |
| Research Site | Arezzo | 52100 | Italy |
| Research Site | Meldola | 47014 | Italy |
| Research Site | Milan | 20132 | Italy |
| Research Site | Milan | 20133 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Orbassano | 10043 | Italy |
| Research Site | Pavia | 27100 | Italy |
| Research Site | Roma | 00152 | Italy |
| Research Site | San Giovanni Rotondo | 71013 | Italy |
| Research Site | Akita | 010-8543 | Japan |
| Research Site | Bunkyō City | 113-8603 | Japan |
| Research Site | Fukuoka | 811-1347 | Japan |
| Research Site | Hakata-shi | 812-0033 | Japan |
| Research Site | Hirosaki-shi | 036-8563 | Japan |
| Research Site | Hiroshima | 730-8518 | Japan |
| Research Site | Izumo-shi | 693-8501 | Japan |
| Research Site | Kagoshima | 890-8520 | Japan |
| Research Site | Kanazawa | 920-8641 | Japan |
| Research Site | Kita-gun | 761-0793 | Japan |
| Research Site | Kobe | 650-0047 | Japan |
| Research Site | Koshigaya-shi | 343-8555 | Japan |
| Research Site | Kōtoku | 135-8550 | Japan |
| Research Site | Kumamoto | 860-0008 | Japan |
| Research Site | Kyoto | 606-8507 | Japan |
| Research Site | Matsuyama | 791-0280 | Japan |
| Research Site | Morioka | 028-3695 | Japan |
| Research Site | Nagasaki | 852-8501 | Japan |
| Research Site | Nagoya | 460-0001 | Japan |
| Research Site | Nagoya | 466-8560 | Japan |
| Research Site | Osaka | 541-8567 | Japan |
| Research Site | Osaka | 545-8586 | Japan |
| Research Site | Osakasayama-shi | 589-8511 | Japan |
| Research Site | Saga | 840-8571 | Japan |
| Research Site | Sagamihara-shi | 252-0315 | Japan |
| Research Site | Sakura-shi | 285-8741 | Japan |
| Research Site | Sapporo | 060-8648 | Japan |
| Research Site | Suita-shi | 565-0871 | Japan |
| Research Site | Takatsuki-shi | 569-8686 | Japan |
| Research Site | Yokohama | 232-0024 | Japan |
| Research Site | Yokohama | 236-0004 | Japan |
| Research Site | Guadalajara | 44280 | Mexico |
| Research Site | León | 37000 | Mexico |
| Research Site | Mexico City | 01120 | Mexico |
| Research Site | México | 04739 | Mexico |
| Research Site | México | 06760 | Mexico |
| Research Site | Monterrey | 64460 | Mexico |
| Research Site | Amsterdam | 1066 CX | Netherlands |
| Research Site | Amsterdam | 1081 HV | Netherlands |
| Research Site | Breda | 4819 EV | Netherlands |
| Research Site | Enschede | 7512 KZ | Netherlands |
| Research Site | Groningen | 9713 GZ | Netherlands |
| Research Site | Leiden | 2333 ZA | Netherlands |
| Research Site | Maastricht | 6229 HX | Netherlands |
| Research Site | Nijmegen | 6525 GA | Netherlands |
| Research Site | Gdansk | 80-462 | Poland |
| Research Site | Gdansk | 80-952 | Poland |
| Research Site | Gdynia | 81-519 | Poland |
| Research Site | Gliwice | 44-101 | Poland |
| Research Site | Olsztyn | 10-228 | Poland |
| Research Site | Otwock | 05-400 | Poland |
| Research Site | Szczecin | 70-111 | Poland |
| Research Site | Warsaw | 02-781 | Poland |
| Research Site | Lisbon | 1649-035 | Portugal |
| Research Site | Loures | 2674-514 | Portugal |
| Research Site | Porto | 4099-001 | Portugal |
| Research Site | Moscow | 105229 | Russia |
| Research Site | Moscow | 115478 | Russia |
| Research Site | Murmansk | 183047 | Russia |
| Research Site | Nizhnyi Novgorod | 603001 | Russia |
| Research Site | Obninsk | 249036 | Russia |
| Research Site | Omsk | 644013 | Russia |
| Research Site | Saint Petersburg | 191014 | Russia |
| Research Site | Saint Petersburg | 191015 | Russia |
| Research Site | Saint Petersburg | 194354 | Russia |
| Research Site | Saint Petersburg | 197758 | Russia |
| Research Site | Saint Petersburg | 199178 | Russia |
| Research Site | Ufa | 450054 | Russia |
| Research Site | Yaroslavl | 150054 | Russia |
| Research Site | Incheon | 21565 | South Korea |
| Research Site | Seongnam-si | 13620 | South Korea |
| Research Site | Seoul | 02841 | South Korea |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 6351 | South Korea |
| Research Site | Badajoz | 06008 | Spain |
| Research Site | Badalona | 08916 | Spain |
| Research Site | Barcelona | 08003 | Spain |
| Research Site | Barcelona | 08243 | Spain |
| Research Site | Elche(Alicante) | 03202 | Spain |
| Research Site | Madrid | 08035 | Spain |
| Research Site | Madrid | 28007 | Spain |
| Research Site | Madrid | 28040 | Spain |
| Research Site | Madrid | 28041 | Spain |
| Research Site | Madrid | 28050 | Spain |
| Research Site | Pozuelo de Alarcón | 28223 | Spain |
| Research Site | Santiago de Compostela | 15706 | Spain |
| Research Site | Seville | 41013 | Spain |
| Research Site | Kaohsiung City | Taiwan |
| Research Site | Taichung | 00407 | Taiwan |
| Research Site | Tainan | 704 | Taiwan |
| Research Site | Taipei | 10002 | Taiwan |
| Research Site | Taipei | 112 | Taiwan |
| Research Site | Taoyuan City | 333 | Taiwan |
| Research Site | Ankara | 06230 | Turkey (Türkiye) |
| Research Site | Edirne | 22030 | Turkey (Türkiye) |
| Research Site | Izmir | 35100 | Turkey (Türkiye) |
| Research Site | Cambridge | CB2 0QQ | United Kingdom |
| Research Site | Cardiff | CF14 2TL | United Kingdom |
| Research Site | Glasgow | G12 0YN | United Kingdom |
| Research Site | Leeds | LS9 7TF | United Kingdom |
| Research Site | London | E1 1BB | United Kingdom |
| Research Site | London | SE1 9RT | United Kingdom |
| Research Site | Manchester | M20 4BX | United Kingdom |
| Research Site | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| Research Site | Sheffield | S10 2SJ | United Kingdom |
| Research Site | Southampton | SO16 6YD | United Kingdom |
| Redacted Protocol | View source |
| FG002 |
| Standard of Care |
Standard of Care Chemotherapy Treatment |
| Received Treatment |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Combination Therapy | MEDI4736 (Durvalumab) + Tremelimumab |
| BG001 | Monotherapy | MEDI4736 (Durvalumab) |
| BG002 | Standard of Care | Standard of Care Chemotherapy Treatment |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set | The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. | Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis. | Posted | Median | 95% Confidence Interval | Months | From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Primary | To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set | The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. | The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control | Posted | Median | 95% Confidence Interval | Months | From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | OS, Full Analysis Set - Durvalumab Monotherapy vs SoC | The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. | Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis. | Posted | Median | 95% Confidence Interval | Months | From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | OS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC | The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. | The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control | Posted | Median | 95% Confidence Interval | Months | From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | OS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy | The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. | The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: <25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND <25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control. | Posted | Median | 95% Confidence Interval | Months | From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | Alive at 24 Months (OS24), Full Analysis Set | Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months. | Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020). |
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| Secondary | Alive at 24 Months (OS24), PD-L1-High Analysis Set | Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months. | The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020). |
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| Secondary | Alive at 24 Months (OS24), PD-L1-Low/Negative Analysis Set | Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months. | The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: <25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND <25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020). |
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| Secondary | PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | Progression free survival (PFS) (per RECIST 1.1, as assessed by investigator) was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. | Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis. | Posted | Median | 95% Confidence Interval | Months | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | PFS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC | Progression free survival (PFS) (per RECIST 1.1, as assessed by investigator) was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. | The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control | Posted | Median | 95% Confidence Interval | Months | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | PFS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy | Progression free survival (PFS) (per RECIST 1.1, as assessed by investigator) was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. | The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: <25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND <25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control. | Posted | Median | 95% Confidence Interval | Months | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | Alive and Progression-free at 12 Months (APF12), Full Analysis Set | Alive and progression-free at 12 months (APF12) was defined as the Kaplan-Meier estimate of PFS (per RECIST 1.1 as assessed by investigator) at 12 months. | Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis. | Posted | Number | 95% Confidence Interval | percentage of participants | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020). |
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| Secondary | Alive and Progression-free at 12 Months (APF12), PD-L1-High Analysis Set | Alive and progression-free at 12 months (APF12) was defined as the Kaplan-Meier estimate of PFS (per RECIST 1.1 as assessed by investigator) at 12 months. | The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control | Posted | Number | 95% Confidence Interval | percentage of participants | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020). |
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| Secondary | Alive and Progression-free at 12 Months (APF12), PD-L1-Low/Negative Analysis Set | Alive and progression-free at 12 months (APF12) was defined as the Kaplan-Meier estimate of PFS (per RECIST 1.1 as assessed by investigator) at 12 months. | The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: <25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND <25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control. | Posted | Number | 95% Confidence Interval | percentage of participants | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020). |
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| Secondary | PFS2, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1). Median PFS2 was calculated using the Kaplan-Meier technique. | Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis. | Posted | Median | 95% Confidence Interval | Months | Tumour scans performed at baseline then every 8 weeks since randomization until first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | PFS2, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC | Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1). Median PFS2 was calculated using the Kaplan-Meier technique. | The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control | Posted | Median | 95% Confidence Interval | Months | Tumour scans performed at baseline then every 8 weeks since randomization until first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | PFS2, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy | Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1). Median PFS2 was calculated using the Kaplan-Meier technique. | The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: <25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND <25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control. | Posted | Median | 95% Confidence Interval | Months | Tumour scans performed at baseline then every 8 weeks since randomization until first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | Objective Response Rate (ORR), Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR. | Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis. | Posted | Number | percentage of participants | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | Objective Response Rate (ORR), PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC | Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR. | The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control | Posted | Number | percentage of participants | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | Objective Response Rate (ORR), PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy | Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR. | The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: <25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND <25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control. | Posted | Number | percentage of participants | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | Objective Response Rate (ORR) Based on BICR Assessment According to RECIST 1.1 - Responses Are Confirmed - Durvalumab Cisplatin Ineligible Population | Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR. unconfirmed responses are excluded. | Durvalumab Cisplatin Ineligible Population include all patients who had received D monotherapy and were not eligible for cisplatin treatment at baseline (per eCRF). | Posted | Number | percentage of participants | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (01NOV2017, a maximum of 3 years). |
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| Secondary | Disease Control Rate (DCR) at 6 Months, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | Disease control rate (DCR) at 6 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 24 weeks (-7 days, i.e., 161 days), following the start of study treatment. | Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis. | Posted | Number | percentage of participants | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 6 months or the data cut-off date (27JAN2020). |
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| Secondary | Disease Control Rate (DCR) at 6 Months, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC | Disease control rate (DCR) at 6 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 24 weeks (-7 days, i.e., 161 days), following the start of study treatment. | The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control | Posted | Number | percentage of participants | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 6 months or the data cut-off date (27JAN2020). |
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| Secondary | Disease Control Rate (DCR) at 6 Months, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy | Disease control rate (DCR) at 6 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 24 weeks (-7 days, i.e., 161 days), following the start of study treatment. | The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: <25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND <25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control. | Posted | Number | percentage of participants | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 6 months or the data cut-off date (27JAN2020). |
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| Secondary | Disease Control Rate (DCR) at 12 Months, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | Disease control rate (DCR) at 12 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 48 weeks (-7 days, i.e., 329 days), following the start of study treatment. | Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis. | Posted | Number | percentage of participants | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020) |
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| Secondary | Disease Control Rate (DCR) at 12 Months, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC | Disease control rate (DCR) at 12 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 48 weeks (-7 days, i.e., 329 days), following the start of study treatment. | The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control | Posted | Number | percentage of participants | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020). |
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| Secondary | Disease Control Rate (DCR) at 12 Months, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy | Disease control rate (DCR) at 12 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 48 weeks (-7 days, i.e., 329 days), following the start of study treatment. | The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: <25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND <25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control. | Posted | Number | percentage of participants | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020). |
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| Secondary | Duration of Response (DoR), Full Analysis Set | Duration of response (DoR) (per RECIST 1.1 as assessed by investigator) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). | Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis. | Posted | Median | Inter-Quartile Range | Months | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | Duration of Response (DoR), PD-L1-High Analysis Set | Duration of response (DoR) (per RECIST 1.1 as assessed by investigator) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). | The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control | Posted | Median | Inter-Quartile Range | Months | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | Duration of Response (DoR), PD-L1-Low/Negative Analysis Set | Duration of response (DoR) (per RECIST 1.1 as assessed by investigator) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). | The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: <25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND <25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control. | Posted | Median | Inter-Quartile Range | Months | Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | Serum Concentrations of Durvalumab, Pharmacokinetic Analysis Set | Blood samples were collected to determine the serum concentration of durvalumab. | Pharmacokinetic analysis set included all patients who received at least 1 dose of durvalumab or tremelimumab per the protocol and had at least one post dose evaluable PK data of durvalumab or tremelimumab | Posted | Mean | Standard Deviation | μg/mL | Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, pre-dose at week 4, and at follow-up Month 3. |
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| Secondary | Serum Concentrations of Tremelimumab, Pharmacokinetic Analysis Set | Blood samples were collected to determine the serum concentration of tremelimumab. | Pharmacokinetic analysis set included all patients who received at least 1 dose of durvalumab or tremelimumab per the protocol and had at least one post dose evaluable PK data of durvalumab or tremelimumab | Posted | Mean | Standard Deviation | μg/mL | Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, pre-dose at week 4, and at follow-up Month 3. |
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| Secondary | Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab, Safety Analysis Set - ADA Evaluable Patients | Serum Samples will be measured for the presence of ADAs and ADA-neutralizing antibodies for Durvalumab using validated assays. Tiered analysis will be performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples will be used. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The category may include patients meeting these criteria who are ADA positive at baseline. | ADA evaluable patients is defined as patients in the safety analysis set who have a non-missing baseline ADA and at least one non-missing post-baseline result | Posted | Count of Participants | Participants | At week 0, 4, 12 and 24, and at follow-up Month 3. |
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| Secondary | Number of Participants With Anti-Drug Antibody (ADA) Response to Tremelimumab, Safety Analysis Set - ADA Evaluable Patients | Serum Samples will be measured for the presence of ADAs and ADA-neutralizing antibodies for Tremelimumab using validated assays. Tiered analysis will be performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples will be used. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The category may include patients meeting these criteria who are ADA positive at baseline. | ADA evaluable patients is defined as patients in the safety analysis set who have a non-missing baseline ADA and at least one non-missing post-baseline result | Posted | Count of Participants | Participants | At week 0, 4, 12 and at follow-up Month 3. |
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| Secondary | Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score. All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104). NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items "I feel weak all overall" and "I feel light-headed (dizzy)". The range of each item is 0-4. Higher score represent worse outcome. | Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis. | Posted | Mean | Standard Error | Scores on a scale | At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score. All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104). NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items "I feel weak all overall" and "I feel light-headed (dizzy)". The range of each item is 0-4. Higher score represent worse | The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control | Posted | Mean | Standard Error | Scores on a scale | At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score. All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104). NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items "I feel weak all overall" and "I feel light-headed (dizzy)". The range of each item is 0-4. Higher score represent worse | The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: <25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND <25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control. | Posted | Mean | Standard Error | Scores on a scale | At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | Improvement in Fatigue and Deterioration in Pain Per FACT-BL, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | Fatigue will be based on the question of "I have a lack of energy" and pain will be based on the question of "I have pain", according to GP1 and GP4 in PWB, respectively. Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL. Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL. | Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis. | Posted | Count of Participants | Participants | At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | Fatigue will be based on the question of "I have a lack of energy" and pain will be based on the question of "I have pain", according to GP1 and GP4 in PWB, respectively. Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL. Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL. | The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control. | Posted | Count of Participants | Participants | At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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| Secondary | Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | Fatigue will be based on the question of "I have a lack of energy" and pain will be based on the question of "I have pain", according to GP1 and GP4 in PWB, respectively. Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL. Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL. | The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: <25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND <25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control. | Posted | Count of Participants | Participants | At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). |
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From first administration of study treatment up to 90 days after last dose of study medication or date of initiation of the first subsequent therapy, whichever occurs first, approximately 5 years. All-cause mortality, from screening up to data cut-off date (27JAN2020, approximately 5 years).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Combination Therapy | MEDI4736 (Durvalumab) + Tremelimumab | 255 | 342 | 179 | 340 | 306 | 340 |
| EG001 | Monotherapy | MEDI4736 (Durvalumab) | 263 | 346 | 139 | 345 | 312 | 345 |
| EG002 | Standard of Care | Standard of Care Chemotherapy Treatment | 270 | 344 | 125 | 313 | 299 | 313 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
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| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
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| Haematotoxicity | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| Left ventricular dysfunction | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| Myocarditis | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| Stress cardiomyopathy | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA 22.1 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA 22.1 | Systematic Assessment |
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| Hypophysitis | Endocrine disorders | MedDRA 22.1 | Systematic Assessment |
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| Hypopituitarism | Endocrine disorders | MedDRA 22.1 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA 22.1 | Systematic Assessment |
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| Thyroiditis | Endocrine disorders | MedDRA 22.1 | Systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA 22.1 | Systematic Assessment |
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| Abdominal hernia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Colonic fistula | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hernia pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Liver abscess | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Contrast media reaction | Immune system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Amoebic dysentery | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Listeriosis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Otitis media chronic | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Prostatic abscess | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Scrotal abscess | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Post procedural fever | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Stoma obstruction | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Urostomy complication | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Autoimmune arthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Neuroendocrine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Renal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Transitional cell carcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cerebral thrombosis | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Immune-mediated neuropathy | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Myasthenic syndrome | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 22.1 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 22.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Bladder tamponade | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Obstructive nephropathy | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Postrenal failure | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Renal vein thrombosis | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary bladder rupture | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Penile haemorrhage | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diaphragmatic paralysis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Science Director | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 4, 2019 | Jan 25, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000613593 | durvalumab |
| C520704 | tremelimumab |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| >= 50 - < 65 |
|
| >= 65 - < 75 |
|
| >= 75 |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| Native Hawaiian or other Pacific islander |
|
| American Indian or Alaska Native |
|
| Other |
|
| Unknown or Not Reported |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Standard of Care |
Standard of Care Chemotherapy Treatment |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG002 |
| Standard of Care |
Standard of Care Chemotherapy Treatment |
|
|
|
| OG002 | Standard of Care | Standard of Care Chemotherapy Treatment |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Standard of Care |
Standard of Care Chemotherapy Treatment |
|
|
|
| OG002 | Standard of Care | Standard of Care Chemotherapy Treatment |
|
|
|
|
|
|
|
|
|
Standard of Care Chemotherapy Treatment
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
|
Standard of Care Chemotherapy Treatment |
|
|
|
| Standard of Care |
Standard of Care Chemotherapy Treatment |
|
|
|
| Counts |
|---|
| Participants |
|
|
|
Standard of Care Chemotherapy Treatment |
|
|
|
| Standard of Care |
Standard of Care Chemotherapy Treatment |
|
|
|
| Participants |
|
|
Standard of Care Chemotherapy Treatment
|
|
Standard of Care Chemotherapy Treatment
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Standard of Care |
Standard of Care Chemotherapy Treatment |
|
|
|
| OG001 | Monotherapy | MEDI4736 (Durvalumab) |
| OG002 | Standard of Care | Standard of Care Chemotherapy Treatment |
|
|
|
| OG001 | Monotherapy | MEDI4736 (Durvalumab) |
| OG002 | Standard of Care | Standard of Care Chemotherapy Treatment |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG002 |
| Standard of Care |
Standard of Care Chemotherapy Treatment |
|
|
|
| OG002 |
| Standard of Care |
Standard of Care Chemotherapy Treatment |
|
|
|