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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002328-35 | EudraCT Number |
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This is a Phase IIIb, interventional, single arm, multicentre study to evaluate safety, effectivenees, use of resources and patient reporting outcomes in patients with ES-SCLC treated with durvalumab in combination with platinum-etoposide as first-line treatment in Spain.
This trial will provide an opportunity to further evaluate the safety profile and efficacy of durvalumab + EP in patient population that is reflective of real-world clinical practice, Durvalumab will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered as monotherapy post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity.
Prophylactic cranial irradiation (PCI) is allowed in patients showing complete or partial responses after the durvalumab + EP combination cycles, at the discretion of the investigator according to their local clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Durvalumab in Combination with Platinum-Etoposide | Experimental | Durvalumab 1500 mg via IV infusion will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | Durvalumab 1500 mg via IV infusion over 60 minutes on Day 1 of each cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events (AEs) Grade ≥ 3 | Patients with AEs grade ≥ 3 acording to NCI CTCAE v5.0 | During study treatment, until disease progression (median 6 months) |
| Number of Patients With Immune-mediated Adverse Events (imAE) | Patients with immune-mediated adverse events (imAE) per patient | During study treatment, until disease progression (median 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS). | PFS: Defined as the time from the first date of treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from investigational product or receives another anticancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable assessment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dolores Isla, M.D. | Hospital Clínico Lozano Blesa, Zaragoza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | A Coruña | 15006 | Spain | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41764558 | Derived | Piedra A, Guinart-Cuadra A, Martinez-Recio S, Mulet M, Zamora C, Osuna-Gomez R, Canto E, Ortiz MA, Alejandre J, Barba A, Sanz-Beltran J, Serra-Lopez J, Isla D, Arriola E, Paz-Ares L, Diz-Tain MP, Moreno AL, Callejo A, Vidal S, Majem M. Baseline PD-L1 expression on circulating immune cells as a predictor of survival and immune-related adverse events in extensive-stage small-cell lung cancer patients treated with durvalumab and carboplatin-etoposide (NCT04712903 Trial). J Transl Med. 2026 Feb 28;24(1):471. doi: 10.1186/s12967-026-07896-7. | |
| 41033130 |
| Label | URL |
|---|---|
| CSR Synopsis | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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 refer 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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101 patients were included in the study have been analysed. All patients included in the analysis started treatment with chemotherapy and durvalumab and 81 of them started maintenance treatment with durvalumab.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Arm | Received study intervention |
| 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 | Feb 2, 2021 | Dec 13, 2024 |
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| Cisplatin | Drug | Cisplatin as an IV infusion per local standards (usually over 60 to 120 minutes on Day 1) of each cycle. |
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| Etoposide | Drug | Etoposide sequentially administered per local standards (usually over 30 to 60 minutes IV infusion) on Days 1, 2, and 3 of each cycle. |
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| Carboplatin | Drug | Carboplatin as an IV infusion per local standards (usually over 30 to 60 minutes on Day 1) of each cycle. |
|
| From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years |
| Objetive Response Rate (ORR) | Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) Criteria for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR | At least every 12 weeks, up to 18 monts |
| Duration of Response (DoR) | DoR: Defined as the time from the date of first documented response per RECIST1.1 until the first date of documented progression per RECIST1.1 or death in the absence of disease progression. | From the date of first documented response until the first date of documented progression or death in the absence of disease progression, assessed up to 2 years. |
| Time to Treatment Discontinuation (TTD) | TTD: Defined as the time from the first date of treatment until the end of treatment date. | From the first date of treatment until the end of treatment date, assessed up to 2 years. |
| Overal Survival (OS) | OS: Defined as the time from the first date of treatment until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive. | From date of inclusion until the date of death, assessed up to 30 months |
| PFS Rate at 6 Months | Percentage of participants remaining alive without disease progression at 6 months after initiation of study treatment. | Every 12 weeks |
| PFS Rate at 12 Months | Percentage of participants remaining alive without disease progression at 12 months after initiation of study treatment. | Every 12 weeks |
| DoR Rate at 12 Months | Percentage of responders remaining alive without disease progression at 12 months after first response. | Every 12 weeks |
| OS Rate at 6 Months | Percentage of participants remaining alive at 6 months after initiation of study treatment. | Every 12 weeks |
| OS Rate at 12 Months | Percentage of participants remaining alive at 12 months after initiation of study treatment. | Every 12 weeks |
| OS Rate at 18 Months | Percentage of participants remaining alive at 18 months after initiation of study treatment. | Every 12 weeks |
| EORTC QLQ-C30: Global Health Status Domain, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-C30: Physical Functioning Domain, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-C30: Role Functioning Domain, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-C30: Emotional Functioning Domain, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-C30: Cognitive Functioning Domain, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-C30: Social Functioning Domain, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-C30: Fatigue, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| . EORTC QLQ-C30: Pain, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-C30: Nausea and Vomiting, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-C30: Dyspnoea, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-C30: Insomnia, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-C30: Appetite Loss, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORCT QLQ-C30: Constipation, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-C30: Diarrhoea, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-C30: Financial Difficulties, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-LC13: Coughing, Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-LC13: Haemoptysis, Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-LC13: Dyspnoea, Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-LC13: Pain in Arm or Shoulder, Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-LC13: Pain in Other Parts, Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-LC13: Sore Mouth, Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-LC13: Peripheral Neuropathy, Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-LC13: Alopecia, Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-LC13: Dysphagia, Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| EORTC QLQ-LC13: Chest Pain Item Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Baseline (cycle 1 day 1) and end of treatment visit. |
| Alicante |
| 03010 |
| Spain |
| Research Site | Badajoz | 6006 | Spain |
| Research Site | Badalona | 08916 | Spain |
| Research Site | Barcelona | 08036 | Spain |
| Research Site | Barcelona | 08908 | Spain |
| Research Site | Barcelona | 8003 | Spain |
| Research Site | Barcelona | ?08041 | Spain |
| Research Site | Castellon | 12004 | Spain |
| Research Site | Córdoba | 14004 | Spain |
| Research Site | Galdakao | 48960 | Spain |
| Research Site | Granada | 18014 | Spain |
| Research Site | Jaén | 23007 | Spain |
| Research Site | León | 24071 | Spain |
| Research Site | Madrid | 28027 | Spain |
| Research Site | Madrid | 28034 | Spain |
| Research Site | Madrid | 28040 | Spain |
| Research Site | Madrid | 28041 | Spain |
| Research Site | Majadahonda | 28222 | Spain |
| Research Site | Mataró | 08304 | Spain |
| Research Site | Málaga | 29011 | Spain |
| Research Site | Murcia | 30008 | Spain |
| Research Site | Ourense | 32005 | Spain |
| Research Site | Oviedo | 33011 | Spain |
| Research Site | Palma | 07198 | Spain |
| Research Site | Reus,Tarragona | 43204 | Spain |
| Research Site | San Cristóbal de La Laguna | 38320 | Spain |
| Research Site | San Sebastián | 20014 | Spain |
| Research Site | Santander | 39008 | Spain |
| Research Site | Santiago de Compostela | 15706 | Spain |
| Research Site | Toledo | 45004 | Spain |
| Research Site | Valencia | 46026 | Spain |
| Research Site | Valladolid | 47003 | Spain |
| Research Site | Zaragoza | 50009 | Spain |
| Derived |
| Isla D, Zugazagoitia J, Arriola E, Garcia-Campelo R, Marti Blanco C, Diz-Tain MP, Lopez-Brea M, Moreno-Vega AL, Leon-Mateos L, Oramas J, Gutierrez-Calderon V, Majem M, Sanchez-Hernandez A, Aguado C, Alvarez-Cabellos R, Massuti B, Moreno A, Firvida-Perez JL, Valdivia J, Gonzalez-Cordero M, Zafra-Poves M, Domine M, Garcia-Navalon FJ, Villanueva N, Provencio M, Juan-Vidal O, Rivas-Corredor C, Olmedo Garcia ME, Palmero R, Lopez-Castro R, Carcereny E, Lechuga JL, Dominguez M, Callejo A, Paz-Ares L. Durvalumab plus platinum-etoposide in the first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): A single-arm clinical trial. Lung Cancer. 2025 Nov;209:108763. doi: 10.1016/j.lungcan.2025.108763. Epub 2025 Sep 24. |
| SAP | View source |
| Protocol | View source |
| COMPLETED | 101 |
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| NOT COMPLETED |
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| ID | Title | Description |
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| BG000 | Experimental Arm | Received study intervention |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years | Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Weight | Mean | Standard Deviation | Kg | Participants |
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| Smoking status | Count of Participants | 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 | Number of Patients With Adverse Events (AEs) Grade ≥ 3 | Patients with AEs grade ≥ 3 acording to NCI CTCAE v5.0 | All patients who received at least one dose of study treatment. | Posted | Count of Participants | Participants | During study treatment, until disease progression (median 6 months) |
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| Primary | Number of Patients With Immune-mediated Adverse Events (imAE) | Patients with immune-mediated adverse events (imAE) per patient | All participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | During study treatment, until disease progression (median 6 months) |
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| Secondary | Progression Free Survival (PFS). | PFS: Defined as the time from the first date of treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from investigational product or receives another anticancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable assessment. | Posted | Median | 95% Confidence Interval | Months | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years |
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| Secondary | Objetive Response Rate (ORR) | Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) Criteria for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR | Posted | Number | 95% Confidence Interval | Percentage of patients | At least every 12 weeks, up to 18 monts |
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| Secondary | Duration of Response (DoR) | DoR: Defined as the time from the date of first documented response per RECIST1.1 until the first date of documented progression per RECIST1.1 or death in the absence of disease progression. | Patients who achieved complete response or partial response. | Posted | Median | 95% Confidence Interval | Months | From the date of first documented response until the first date of documented progression or death in the absence of disease progression, assessed up to 2 years. |
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| Secondary | Time to Treatment Discontinuation (TTD) | TTD: Defined as the time from the first date of treatment until the end of treatment date. | Posted | Median | Inter-Quartile Range | Months | From the first date of treatment until the end of treatment date, assessed up to 2 years. |
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| Secondary | Overal Survival (OS) | OS: Defined as the time from the first date of treatment until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive. | Posted | Median | 95% Confidence Interval | Months | From date of inclusion until the date of death, assessed up to 30 months |
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| Secondary | PFS Rate at 6 Months | Percentage of participants remaining alive without disease progression at 6 months after initiation of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of patients | Every 12 weeks |
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| Secondary | PFS Rate at 12 Months | Percentage of participants remaining alive without disease progression at 12 months after initiation of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of patients | Every 12 weeks |
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| Secondary | DoR Rate at 12 Months | Percentage of responders remaining alive without disease progression at 12 months after first response. | Patients who achieved complete response or partial response. | Posted | Number | 95% Confidence Interval | Percentage of patients | Every 12 weeks |
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| Secondary | OS Rate at 6 Months | Percentage of participants remaining alive at 6 months after initiation of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of patients | Every 12 weeks |
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| Secondary | OS Rate at 12 Months | Percentage of participants remaining alive at 12 months after initiation of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of patients | Every 12 weeks |
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| Secondary | OS Rate at 18 Months | Percentage of participants remaining alive at 18 months after initiation of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of patients | Every 12 weeks |
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| Secondary | EORTC QLQ-C30: Global Health Status Domain, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-C30: Physical Functioning Domain, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-C30: Role Functioning Domain, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-C30: Emotional Functioning Domain, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-C30: Cognitive Functioning Domain, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-C30: Social Functioning Domain, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-C30: Fatigue, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | . EORTC QLQ-C30: Pain, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-C30: Nausea and Vomiting, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-C30: Dyspnoea, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-C30: Insomnia, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-C30: Appetite Loss, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORCT QLQ-C30: Constipation, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-C30: Diarrhoea, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-C30: Financial Difficulties, Change From Baseline to End of Treatment Visit | EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties). For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-LC13: Coughing, Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-LC13: Haemoptysis, Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-LC13: Dyspnoea, Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-LC13: Pain in Arm or Shoulder, Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-LC13: Pain in Other Parts, Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-LC13: Sore Mouth, Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-LC13: Peripheral Neuropathy, Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-LC13: Alopecia, Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-LC13: Dysphagia, Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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| Secondary | EORTC QLQ-LC13: Chest Pain Item Change From Baseline to End of Treatment Visit | EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. Change from baseline is the difference in the score between the end of treatment visit and the first visit. | Enrolled participants who completed baseline and end of treatment questionnaires. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (cycle 1 day 1) and end of treatment visit. |
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During study treatment, until disease progression (median 6 months)
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 | Experimental Arm | Received study intervention | 76 | 101 | 57 | 101 | 100 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Pancytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiac failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardio-respiratory arrest | Cardiac disorders | Non-systematic Assessment |
| ||
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | Non-systematic Assessment |
| ||
| Diplopia | Eye disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Haematemesis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Chest pain | General disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Bile duct stone | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Hepatitis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Non-systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Non-systematic Assessment |
| ||
| COVID-19 pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Herpes zoster reactivation | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Staphylococcal infection | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Radial head dislocation | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Non-systematic Assessment |
| ||
| Transaminases increased | Investigations | Non-systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Rectal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Cerebellar syndrome | Nervous system disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Haemorrhage intracranial | Nervous system disorders | Non-systematic Assessment |
| ||
| Immune-mediated neurological disorder | Nervous system disorders | Non-systematic Assessment |
| ||
| Multiple sclerosis | Nervous system disorders | Non-systematic Assessment |
| ||
| Neurological decompensation | Nervous system disorders | Non-systematic Assessment |
| ||
| Seizure | Nervous system disorders | Non-systematic Assessment |
| ||
| Spinal cord compression | Nervous system disorders | Non-systematic Assessment |
| ||
| Syncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Confusional state | Psychiatric disorders | Non-systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Nephritis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Renal tubular disorder | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Skin reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Peripheral ischaemia | Vascular disorders | Non-systematic Assessment |
| ||
| Superior vena cava syndrome | Vascular disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Asthenia | General disorders | Non-systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Hypothyroidism | Endocrine disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Platelet count decreased | Investigations | Non-systematic Assessment |
| ||
| Mucosal inflammation | General disorders | Non-systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Hypomagnesaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Oedema peripheral | General disorders | Non-systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Hyperthyroidism | Endocrine disorders | Non-systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Amylase increased | Investigations | Non-systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Illness | General disorders | Non-systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Non-systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Gamma-glutamyltransferase increased | Investigations | Non-systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Non-systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 10, 2021 | Dec 13, 2024 | SAP_005.pdf |
Not provided
| ID | Term |
|---|---|
| C000613593 | durvalumab |
| D002945 | Cisplatin |
| D005047 | Etoposide |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Unknown or Not Reported |
|
| Not available |
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