Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001402-20 | EudraCT Number |
Not provided
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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
| Parexel | INDUSTRY |
| Medidata Solutions | INDUSTRY |
| CISCRP |
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The aims of the study are to monitor the long-term safety of durvalumab, to provide continued treatment or retreatment with durvalumab to eligible patients, and to collect overall survival (OS) information.
This is a multicenter, open-label, global study that will enroll patients who are currently receiving durvalumab monotherapy, or have previously received durvalumab as monotherapy or in combination with any other approved or investigational anticancer agents, in an eligible AstraZeneca/MedImmune-sponsored clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Durvalumab Monotherapy |
|
| Off Treatment | No Intervention | Follow up Only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | IV infusion q4w with 1500mg durvalumab until progressive disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was the development of any untoward medical occurrence (other than progression of the malignancy under evaluation) in a participant or clinical study participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A SAE was an AE occurring during any study phase that fulfilled one or more of the following: resulted in death; was immediately life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital abnormality or birth defect; was an important medical event that jeopardized the participant or required medical treatment to prevent one of the outcomes listed above. | From the time of signing the informed consent form until the follow-up period is completed (90 days after the last dose of durvalumab); approximately 37 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 2: Overall Response Rate (ORR) | The ORR was defined as the percentage of participants with a confirmed investigator-assessed response of either complete response (CR) or partial response (PR) from the date of re-initiation of treatment with durvalumab monotherapy. Tumor assessments were performed according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target lesions (TLs) since baseline and reduction in short axis diameter to <10 millimeters (mm) for any pathological lymph nodes selected as TLs. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameter. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
The following exclusion criteria apply only to patients receiving treatment or retreatment:
Not provided
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Jared Weiss, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fullerton | California | 92835 | United States | ||
| Research Site |
Not provided
| Label | URL |
|---|---|
| Redacted CSP | View source |
| Redacted SAP | View source |
Not provided
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment.
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.
A total of 163 participants were enrolled in this study.
This Phase IV, open-label study was conducted at 112 investigational sites across 31 countries in participants who were receiving durvalumab monotherapy and/or those who previously received durvalumab as a monotherapy or in combination with any other approved or investigational anticancer agent in previously enrolled parent study between 05 Sep 2019 and 31 Oct 2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Durvalumab Continuation | Cohort 1 included participants who had received durvalumab monotherapy or durvalumab combination therapy under the parent clinical study (including those who underwent retreatment per the parent study) who had not clinically progressed and who were eligible to continue durvalumab treatment after completing dosing of all other anticancer agents, including other investigational agents. Participants received durvalumab monotherapy 1500 milligrams (mg) via intravenous (IV) infusion every 4 weeks on Day 1 of each cycle until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 12, 2022 | Aug 13, 2024 |
Not provided
Not provided
Not provided
All involved know the identity of the intervention assignment.
Not provided
| Tumor assessments as determined by the Investigator (at least every 12 weeks) until withdrawal of consent, progression or death; approximately 30 months |
| Cohort 2: Duration of Response (DOR) | The DOR was defined as the time from first documented CR or PR to time of first documented disease progression or death in the absence of disease progression. Tumor assessments were performed according to RECIST v1.1. | Tumor assessments as determined by the Investigator (at least every 12 weeks) until withdrawal of consent, progression or death; approximately 30 months |
| Number of Participants Who Were Alive | Number of participants who were alive are reported in this outcome measure. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. | Up to approximately 37 months |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Research Site | Augusta | Georgia | 30912 | United States |
| Research Site | Baltimore | Maryland | 21201 | United States |
| Research Site | Minneapolis | Minnesota | 55407 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | Mineola | New York | 11501 | United States |
| Research Site | Chapel Hill | North Carolina | 27514 | United States |
| Research Site | Huntersville | North Carolina | 28078 | United States |
| Research Site | Greenville | South Carolina | 29605 | United States |
| Research Site | Nashville | Tennessee | 37203 | United States |
| Research Site | Dallas | Texas | 75251 | United States |
| Research Site | Rosario | S2000KZE | Argentina |
| Research Site | Box Hill | 3128 | Australia |
| Research Site | Melbourne | 3000 | Australia |
| Research Site | Brussels | 1090 | Belgium |
| Research Site | Kortrijk | 8500 | Belgium |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Florianópolis | 88034-000 | Brazil |
| Research Site | Ijuí | 98700-000 | Brazil |
| Research Site | Porto Alegre | 90035-903 | Brazil |
| Research Site | São José do Rio Preto | 15090-000 | Brazil |
| Research Site | Sofia | 1612 | Bulgaria |
| Research Site | Calgary | Alberta | T2N 4N2 | Canada |
| Research Site | Toronto | CA | M5G 2M9 | Canada |
| Research Site | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| Research Site | Newmarket | Ontario | L3Y 2P9 | Canada |
| Research Site | Santiago | 7500000 | Chile |
| Research Site | Olomouc | 775 20 | Czechia |
| Research Site | Brest | 29609 | France |
| Research Site | Lille | 59037 | France |
| Research Site | Lyon | 69373 | France |
| Research Site | Dresden | 1307 | Germany |
| Research Site | Hanover | 30625 | Germany |
| Research Site | Holargos, Athens | 155 62 | Greece |
| Research Site | Budapest | 1121 | Hungary |
| Research Site | Miskolc | 3526 | Hungary |
| Research Site | Chennai | 600006 | India |
| Research Site | Haifa | 91096 | Israel |
| Research Site | Bunkyō City | 113-8677 | Japan |
| Research Site | Fukushima | 960-1295 | Japan |
| Research Site | Isehara-shi | 259-1193 | Japan |
| Research Site | Izumi-shi | 594-0073 | Japan |
| Research Site | Kishiwada-shi | 596-8501 | Japan |
| Research Site | Kōtoku | 135-8550 | Japan |
| Research Site | Nagaoka-shi | 940-2085 | Japan |
| Research Site | Nagoya | 466-8560 | Japan |
| Research Site | Natori-shi | 981-1293 | Japan |
| Research Site | Okayama | 700-8558 | Japan |
| Research Site | Osaka | 541-8567 | Japan |
| Research Site | Saga | 840-8571 | Japan |
| Research Site | Suita-shi | 565-0871 | Japan |
| Research Site | Sunto-gun | 411-8777 | Japan |
| Research Site | Tokushima | 770-8503 | Japan |
| Research Site | Yokohama | 241-8515 | Japan |
| Research Site | Kuching | 93586 | Malaysia |
| Research Site | Amsterdam | 1066 CX | Netherlands |
| Research Site | Arnhem | 6815 AD | Netherlands |
| Research Site | Lodz | 90-302 | Poland |
| Research Site | Lodz | 93-509 | Poland |
| Research Site | Olsztyn | 10-357 | Poland |
| Research Site | Craiova | 200347 | Romania |
| Research Site | Suceava | 720237 | Romania |
| Research Site | Arkhangelsk | 163045 | Russia |
| Research Site | Moscow | 111123 | Russia |
| Research Site | Moscow | 115280 | Russia |
| Research Site | Omsk | 644013 | Russia |
| Research Site | pos.Pesochnyi | 197758 | Russia |
| Research Site | Saint Petersburg | 197022 | Russia |
| Research Site | Saint Petersburg | 197758 | Russia |
| Research Site | Kamenitz | 21204 | Serbia |
| Research Site | Daegu | 41931 | South Korea |
| Research Site | Gwangju | 61469 | South Korea |
| Research Site | Gyeongsangnam-do | 52727 | South Korea |
| Research Site | Seogu | 49241 | South Korea |
| Research Site | Seongnam-si | 13620 | South Korea |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 06351 | South Korea |
| Research Site | Badalona | 08916 | Spain |
| Research Site | Barcelona | 08028 | Spain |
| Research Site | Barcelona | 08035 | Spain |
| Research Site | Barcelona | 08041 | Spain |
| Research Site | Girona | 17007 | Spain |
| Research Site | Jaén | 23007 | Spain |
| Research Site | Madrid | 28041 | Spain |
| Research Site | Madrid | 28046 | Spain |
| Research Site | Marbella | 29600 | Spain |
| Research Site | Málaga | 29010 | Spain |
| Research Site | Valencia | 46026 | Spain |
| Research Site | Bellinzona | CH-6500 | Switzerland |
| Research Site | Lausanne | 1011 | Switzerland |
| Research Site | New Taipei City | 23561 | Taiwan |
| Research Site | Taichung | 40447 | Taiwan |
| Research Site | Taichung | 40705 | Taiwan |
| Research Site | Tainan | 704 | Taiwan |
| Research Site | Taipei | 11217 | Taiwan |
| Research Site | Bangkok | 10330 | Thailand |
| Research Site | Songkhla | 90110 | Thailand |
| Research Site | Adana | 01120 | Turkey (Türkiye) |
| Research Site | Istanbul | 34098 | Turkey (Türkiye) |
| Research Site | Chernivtsі | 58013 | Ukraine |
| Research Site | Ivano-Frankivsk | 76018 | Ukraine |
| Research Site | Kharkiv | 61070 | Ukraine |
| Research Site | Kirovohrad | 25006 | Ukraine |
| Research Site | Kryvyi Rih | 50048 | Ukraine |
| Research Site | Kyiv | 03022 | Ukraine |
| Research Site | Kyiv | 03115 | Ukraine |
| Research Site | Kyiv | 8112 | Ukraine |
| Research Site | Sumy | 40005 | Ukraine |
| Research Site | Uzhhorod | 88014 | Ukraine |
| Research Site | Vinnytsia | 21029 | Ukraine |
| Research Site | London | EC1A 7BE | United Kingdom |
| Research Site | London | WC1N 3BG | United Kingdom |
| Research Site | Manchester | M20 4BX | United Kingdom |
| Research Site | Hanoi | 100000 | Vietnam |
| Redacted CSR Synopsis | View source |
| FG001 | Cohort 2: Durvalumab Restart | Cohort 2 included participants who had completed durvalumab monotherapy or combination therapy with any other approved or investigational anticancer agents in a parent study, without confirmed PD during the period of treatment, and who were potentially eligible for retreatment with durvalumab. Participants received durvalumab monotherapy 1500 mg via IV infusion every 4 weeks on Day 1 of each cycle until confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| FG002 | Cohort 3: No Restart of Durvalumab | Cohort 3 included participants previously treated with durvalumab monotherapy or in combination with any other approved or investigational anticancer agents who were no longer receiving durvalumab and were not eligible to receive retreatment. Participants did not receive any study drug. |
| Received Treatment in This Study/Within 90 Days Prior Enrolment in This Study(Safety Analysis Set) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Full analysis set included all participants enrolled in the study, regardless of the treatment received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Durvalumab Continuation | Cohort 1 included participants who had received durvalumab monotherapy or durvalumab combination therapy under the parent clinical study (including those who underwent retreatment per the parent study) who had not clinically progressed and who were eligible to continue durvalumab treatment after completing dosing of all other anticancer agents, including other investigational agents. Participants received durvalumab monotherapy 1500 mg via IV infusion every 4 weeks on Day 1 of each cycle until confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| BG001 | Cohort 2: Durvalumab Restart | Cohort 2 included participants who had completed durvalumab monotherapy or combination therapy with any other approved or investigational anticancer agents in a parent study, without confirmed PD during the period of treatment, and who were potentially eligible for retreatment with durvalumab. Participants received durvalumab monotherapy 1500 mg via IV infusion every 4 weeks on Day 1 of each cycle until confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| BG002 | Cohort 3: No Restart of Durvalumab | Cohort 3 included participants previously treated with durvalumab monotherapy or in combination with any other approved or investigational anticancer agents who were no longer receiving durvalumab and were not eligible to receive retreatment. Participants did not receive any study drug. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was the development of any untoward medical occurrence (other than progression of the malignancy under evaluation) in a participant or clinical study participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A SAE was an AE occurring during any study phase that fulfilled one or more of the following: resulted in death; was immediately life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital abnormality or birth defect; was an important medical event that jeopardized the participant or required medical treatment to prevent one of the outcomes listed above. | The Safety analysis set included those participants who received at least 1 dose of durvalumab in this study or enrolled in this study within 90 days of the last dose of durvalumab or durvalumab combination in the respective parent clinical study. The data is from this study only, parent study data is not included in this table. | Posted | Count of Participants | Participants | From the time of signing the informed consent form until the follow-up period is completed (90 days after the last dose of durvalumab); approximately 37 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Cohort 2: Overall Response Rate (ORR) | The ORR was defined as the percentage of participants with a confirmed investigator-assessed response of either complete response (CR) or partial response (PR) from the date of re-initiation of treatment with durvalumab monotherapy. Tumor assessments were performed according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target lesions (TLs) since baseline and reduction in short axis diameter to <10 millimeters (mm) for any pathological lymph nodes selected as TLs. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameter. | The Response evaluable analysis set included those participants who underwent retreatment with durvalumab in Cohort 2. | Posted | Number | 95% Confidence Interval | percentage of participants | Tumor assessments as determined by the Investigator (at least every 12 weeks) until withdrawal of consent, progression or death; approximately 30 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Cohort 2: Duration of Response (DOR) | The DOR was defined as the time from first documented CR or PR to time of first documented disease progression or death in the absence of disease progression. Tumor assessments were performed according to RECIST v1.1. | The Response evaluable analysis set included those participants who underwent retreatment with durvalumab in Cohort 2. | Posted | Median | 95% Confidence Interval | months | Tumor assessments as determined by the Investigator (at least every 12 weeks) until withdrawal of consent, progression or death; approximately 30 months |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Were Alive | Number of participants who were alive are reported in this outcome measure. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. | The Full analysis set included all participants enrolled in the study, regardless of the treatment received. | Posted | Count of Participants | Participants | Up to approximately 37 months |
|
From the time of signing the informed consent form until the follow-up period is completed (90 days after the last dose of durvalumab); approximately 37 months
The Safety analysis set included those participants who received at least 1 dose of durvalumab on this study or enrolled on this study within 90 days of the last dose of durvalumab or durvalumab combination on the respective parent clinical study. All-cause mortality was reported for Full analysis set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Durvalumab Continuation | Cohort 1 included participants who had received durvalumab monotherapy or durvalumab combination therapy under the parent clinical study (including those who underwent retreatment per the parent study) who had not clinically progressed and who were eligible to continue durvalumab treatment after completing dosing of all other anticancer agents, including other investigational agents. Participants received durvalumab monotherapy 1500 mg via IV infusion every 4 weeks on Day 1 of each cycle until confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. | 10 | 100 | 23 | 100 | 72 | 100 |
| EG001 | Cohort 2: Durvalumab Restart | Cohort 2 included participants who had completed durvalumab monotherapy or combination therapy with any other approved or investigational anticancer agents in a parent study, without confirmed PD during the period of treatment, and who were potentially eligible for retreatment with durvalumab. Participants received durvalumab monotherapy 1500 mg via IV infusion every 4 weeks on Day 1 of each cycle until confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. | 2 | 25 | 0 | 7 | 1 | 7 |
| EG002 | Cohort 3: No Restart of Durvalumab | Cohort 3 included participants previously treated with durvalumab monotherapy or in combination with any other approved or investigational anticancer agents who were no longer receiving durvalumab and were not eligible to receive retreatment. Participants did not receive any study drug. | 12 | 38 | 0 | 2 | 0 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA version 25.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA version 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 25.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA version 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 23, 2022 | Aug 13, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613593 | durvalumab |
Not provided
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| Not Hispanic or Latino |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG002 | Cohort 3: No Restart of Durvalumab | Cohort 3 included participants previously treated with durvalumab monotherapy or in combination with any other approved or investigational anticancer agents who were no longer receiving durvalumab and were not eligible to receive retreatment. Participants did not receive any study drug. |
|
|