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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003331-30 | EudraCT Number |
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This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 [anti-PD-L1] antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody | Experimental | Atezolizumab 1200 milligrams (mg) was administered via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first. |
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| Docetaxel | Active Comparator | Docetaxel 75 milligrams per meter square (mg/m^2) was administered via IV infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | 1200 mg IV infusion on Day 1 of each 21-day cycle |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Died: PP-ITT | Baseline until death due to any cause (up to approximately 2.25 years) | |
| Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP | Percentage of participants who died among TC1/2/3 or IC1/2/3 subgroup of PP-ITT were reported. TC1 = presence of discernible programmed death-ligand 1 (PD-L1) staining of any intensity in >/=1% and <5% TCs; TC2: presence of discernible PD-L1 staining of any intensity in >/=5% and <50% TCs; TC3 = presence of discernible PD-L1 staining of any intensity in >/=50% TCs; IC1 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=1% and <5% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC2 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=5% and <10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC3 = presence of discernible PD-L1 staining of any intensity in ICs covering >/=10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma. | Baseline until death due to any cause (up to approximately 2.25 years) |
| Overall Survival (OS): PP-ITT | OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology. | Baseline until death due to any cause (up to approximately 2.25 years) |
| OS: TC1/2/3 or IC1/2/3 Subgroup of PP | OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT | PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeters (mm), or presence of new lesions. | Baseline up to PD or Death (up to approximately 2.25 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Blood/Cancer Ctr | Bakersfield | California | 93309 | United States | ||
| Roy & Patricia Disney Family Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41592891 | Derived | Melchionna R, Di Modugno F, Di Carlo A, D'Ambrosio L, Palermo B, Tocci A, Paolini F, Sperduti I, Campo G, Taje R, Gallina F, Visca P, D'Andrea D, Nistico P. Reciprocal regulation of hMENA and TGF-beta signaling in cancer-associated fibroblasts promotes EMT, immunosuppression, poor prognosis, and ICT resistance in NSCLC. J Immunother Cancer. 2026 Jan 27;14(1):e013098. doi: 10.1136/jitc-2025-013098. | |
| 37696652 |
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Twelve hundred and twenty-five participants were randomized in the study and were considered the Secondary Population (SP), out of which first 850 randomized participants were considered the Primary Population (PP).
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| ID | Title | Description |
|---|---|---|
| FG000 | Docetaxel | Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
| FG001 | Atezolizumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Docetaxel | Drug | 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle |
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| Baseline until death due to any cause (up to approximately 2.25 years) |
| OS: SP-ITT | OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology. | Baseline until death due to any cause (up to approximately 2.87 years) |
| OS: TC1/2/3 Or IC1/2/3 Subgroup of SP | OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology. | Baseline until death from any cause (approximately 2.87 years) |
| OS: TC2/3 or IC2/3 Subgroup of SP | OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology. | Baseline until death due to any cause (up to approximately 2.87 years) |
| OS: TC3 or IC3 Subgroup of SP | OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology. | Baseline until death due to any cause (up to approximately 2.87 years) |
| Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP | PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions. | Baseline up to PD or Death (up to approximately 2.25 years) |
| Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT | PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions. | Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years) |
| PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP | PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions. | Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years) |
| Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT | Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions. | Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years) |
| Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP | Objective response is defined as a CR or PR as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions. | Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years) |
| Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT | DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology. | From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years) |
| DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP | DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology. | From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years) |
| Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab | Baseline up to approximately 2.25 years (assessed at predose [Hour {Hr} 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, then every 8 cycles up to end of treatment (EOT) [approximately 2.25 years]; 120 days after EOT [approximately 2.25 years] [1 Cycle=21 days]) |
| Maximum Observed Serum Atezolizumab Concentration (Cmax) | Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days) |
| Minimum Observed Serum Atezolizumab Concentration (Cmin) | Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days) |
| Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13) | TTD in patient-reported lung cancer symptoms (pain in chest or in arm/shoulder, dyspnea, or cough) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the symptoms. A >/=10-point change in the score perceived by participants was considered as clinically significant. The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity. | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days) |
| EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items | EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement). | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
| EORTC QLQ-C30 Questionnaire Score: Functional Subscales | EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement). | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
| EORTC QLQ-C30 Questionnaire Score: GHS Scale | EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement). | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
| EORTC QLQ-C30 Questionnaire Score: Symptom Subscale | EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement). | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
| EORTC QLQ-LC13 Questionnaire Score: Alopecia | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for alopecia. | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
| EORTC QLQ-LC13 Questionnaire Score: Coughing | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for coughing. | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
| EORTC QLQ-LC13 Questionnaire Score: Dysphagia | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dysphagia. | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
| EORTC QLQ-LC13 Questionnaire Score: Dyspnea | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dyspnea. | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
| EORTC QLQ-LC13 Questionnaire Score: Hemoptysis | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for hemoptysis. | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
| EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in arm or shoulder. | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
| EORTC QLQ-LC13 Questionnaire Score: Pain in Chest | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in chest. | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
| EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for peripheral neuropathy. | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
| EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in other parts. | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
| EORTC QLQ-LC13 Questionnaire Score: Sore Mouth | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for sore mouth. | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
| PFS as Determined by Investigator Using RECIST v1.1: SP-ITT | PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions. | Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years) |
| Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT | Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions. | Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years) |
| DOR as Determined by Investigator Using RECIST v1.1: SP ITT | DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology. | From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years) |
| Burbank |
| California |
| 91505 |
| United States |
| St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr | Fullerton | California | 92835 | United States |
| Kaiser Permanente - Hayward | Hayward | California | 94545 | United States |
| Scripps Clinic; Hematology & Oncology | La Jolla | California | 92037-1027 | United States |
| Pacific Shores Medical Group | Long Beach | California | 90813 | United States |
| Univ of Calif, Los Angeles; Hematology/Oncology | Los Angeles | California | 90095 | United States |
| North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can Ctr | Northridge | California | 91328 | United States |
| Kaiser Permanente - Oakland | Oakland | California | 94611 | United States |
| TMPN/ Cancer Care Associates | Redondo Beach | California | 90277 | United States |
| Kaiser Permanente - Roseville | Roseville | California | 95661 | United States |
| Kaiser Permanente Sacramento Medical Center | Sacramento | California | 95814 | United States |
| UC Davis; Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| Kaiser Permanente - San Francisco (2238 Geary) | San Francisco | California | 94115 | United States |
| K. Permanente - San Jose | San Jose | California | 95119 | United States |
| Coastal Integrative Cancer Care | San Luis Obispo | California | 93401 | United States |
| Kaiser Permanente - San Marcos | San Marcos | California | 92069 | United States |
| K. Permanente - Santa Clara | Santa Clara | California | 95051 | United States |
| Central Coast Medical Oncology | Santa Maria | California | 93454 | United States |
| K. Permanente - S. San Fran | South San Francisco | California | 94080 | United States |
| Kaiser Permanente - Vallejo | Vallejo | California | 94589 | United States |
| K. Permanente - Walnut Creek | Walnut Creek | California | 94596 | United States |
| St. Mary's Hospital Regional Cancer Center | Grand Junction | Colorado | 81501 | United States |
| Kaiser Permanente - Franklin; Kaiser Permanente - Lone Tree | Lone Tree | Colorado | United States |
| Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy) | Jacksonville | Florida | 32256 | United States |
| AMPM Research Clinic | Miami | Florida | 33145 | United States |
| Orlando Health Inc. | Orlando | Florida | 32806 | United States |
| Georgia Cancer Specialists | Atlanta | Georgia | 30341 | United States |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Illinois Cancer Care | Peoria | Illinois | 61615 | United States |
| Quincy Medical Group | Quincy | Illinois | 62301 | United States |
| Hematology-Oncology; Associates of the Quad Cities | Bettendorf | Iowa | 52722 | United States |
| New England Cancer Specialists | Scarborough | Maine | 04074 | United States |
| Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building | Detroit | Michigan | 48201 | United States |
| US Oncology Research at Minnesota Oncology | Minneapolis | Minnesota | 55404 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Billings Clinic; Research Center | Billings | Montana | 59101 | United States |
| Montana Cancer Specialists | Missoula | Montana | 59802 | United States |
| Oncology Hematology West Midwest | Omaha | Nebraska | 68130 | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89014 | United States |
| Comprehensive Cancer Centers of Nevada - Eastern Avenue | Las Vegas | Nevada | 89169 | United States |
| Summit Medical Center | Florham Park | New Jersey | 07932 | United States |
| Luckow Pavillion, Valley Hosp; Office of Clinical Trials | Paramus | New Jersey | 07652 | United States |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | United States |
| Roswell Park Cancer Inst. | Buffalo | New York | 14263 | United States |
| New York Oncology Hematology PC - Latham | Clifton Park | New York | 12065 | United States |
| Mid Ohio Onc Hematology Inc | Columbus | Ohio | 43219 | United States |
| Cancer Treatment Centers of America-Tulsa | Tulsa | Oklahoma | 74133 | United States |
| Willamette Valley Cancer Ctr - 520 Country Club | Eugene | Oregon | 97401-8122 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Texas Onc-Central Austin CA Ct | Austin | Texas | 78731 | United States |
| The Methodist Cancer Center | Houston | Texas | 77030 | United States |
| Texas Oncology, P.A. - Tyler; Tyler Cancer Center | Tyler | Texas | 75702 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | United States |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |
| Northwest Cancer Specialists - Vancouver | Vancouver | Washington | 98684 | United States |
| Aurora Health Care; Patient Centered Research | Milwaukee | Wisconsin | 53215 | United States |
| Instituto Medico Rio Cuarto | Córdoba | Argentina |
| COIBA | Provincia de Buenos Aires | B1884BBF | Argentina |
| Instituto de Oncología de Rosario | Rosario | S2000KZE | Argentina |
| Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin | Innsbruck | 6020 | Austria |
| Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt. | Salzburg | 5020 | Austria |
| Lkh Vöcklabruck; I. Abt. Für Innere Medizin | Vöcklabruck | 4840 | Austria |
| Hospital das Clinicas - UFRGS | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Windsor Regional Cancer Centre | Windsor | Ontario | N8W 2X3 | Canada |
| Cite de La Sante de Laval; Hemato-Oncologie | Laval | Quebec | H7M 3L9 | Canada |
| McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology | Montreal | Quebec | H3T 1E2 | Canada |
| Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas | Recoleta | 8420383 | Chile |
| Sociedad de Investigaciones Medicas Ltda (SIM) | Temuco | 4810469 | Chile |
| ONCOCENTRO APYS; Oncología | Viña del Mar | 2520598 | Chile |
| Helsinki University Central Hospital; Dep. of Pulmonary Medicine | Helsinki | 00290 | Finland |
| Oulu University Hospital; Oncology | Oulu | 90029 | Finland |
| Tampere University Hospital; Dept of Oncology | Tampere | 33520 | Finland |
| Institut Sainte Catherine | Avignon | 84918 | France |
| Hopital Jean Minjoz; Pneumologie | Besançon | 25030 | France |
| Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie | Bordeaux | 33077 | France |
| Centre Francois Baclesse | Caen | 14076 | France |
| Centre Hospitalier Intercommunal; Service de Pneumologie | Créteil | 94010 | France |
| Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie | Grenoble | 38043 | France |
| Centre Jean Bernard; Radiotherapie Chimiotherapie | Le Mans | 72000 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique | Marseille | 13915 | France |
| Hopital Emile Muller;Pneumologie | Mulhouse | 68070 | France |
| Hopital Cochin; Unite Fonctionnelle D Oncologie | Paris | 75014 | France |
| Hopital Saint Louis; Oncologie Medicale | Paris | 75475 | France |
| GH Paris Saint Joseph; Pneumologie | Paris | 75674 | France |
| Hopital Tenon;Pneumologie | Paris | 75970 | France |
| Centre Hospitalier Lyon Sud; Pneumologie | Pierre-Bénite | 69495 | France |
| CH de la region d Annecy | Pringy | 74374 | France |
| Hopital de Pontchaillou; Service de Pneumologie | Rennes | 35033 | France |
| Centre Paul Strauss; Oncologie Medicale | Strasbourg | 67065 | France |
| Hopital Foch; Pneumologie | Suresnes | 92151 | France |
| Hia Sainte Anne; Pneumologie | Toulon | 83041 | France |
| Hopital Larrey; Pneumologie | Toulouse | 31059 | France |
| Helios Klinikum Emil von Behring GmbH | Berlin | 14165 | Germany |
| Krankenhaus Merheim Lungenklinik | Cologne | 51109 | Germany |
| Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie | Frankfurt | 60488 | Germany |
| Asklepios-Fachkliniken Muenchen-Gauting; Onkologie | Gauting | 82131 | Germany |
| Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II | Halle | 06120 | Germany |
| Thoraxklinik Heidelberg gGmbH | Heidelberg | 69126 | Germany |
| Lungenklinik Hemer | Hemer | 58675 | Germany |
| Fachklinik für Lungenerkrankungen | Immenhausen | 34376 | Germany |
| Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie | Regensburg | 93053 | Germany |
| Uoa Sotiria Hospital; Oncology | Athens | 115 27 | Greece |
| University Hospital of Patras Medical Oncology | Pátrai | 265 04 | Greece |
| Thermi Clinic; Oncology Clinic | Thermi Thessalonikis | 570 01 | Greece |
| Grupo Angeles | Guatemala City | 01015 | Guatemala |
| Semmelweis Egyetem X; Pulmonologiai Klinika | Budapest | 1083 | Hungary |
| University of Pecs, I st Dept of Internal Medicine | Pécs | 7624 | Hungary |
| Tudogyogyintezet Torokbalint | Törökbálint | 2045 | Hungary |
| Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica | Bari | Apulia | 70124 | Italy |
| Azienda Ospedaliera San Giuseppe Moscati | Avellino | Campania | 83100 | Italy |
| Seconda Universita' Degli Studi; Divsione Di Oncologia Medica | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliera Univ Parma; Dept Oncologia Medica | Parma | Emilia-Romagna | 43100 | Italy |
| Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica | Aviano | Friuli Venezia Giulia | 33081 | Italy |
| Azienda Ospedaliero-Uni Ria Di Udine; Dept. Di Oncologia - Padiglione Pennato | Udine | Friuli Venezia Giulia | 33100 | Italy |
| Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna | Rome | Lazio | 00168 | Italy |
| Istituto Nazionale per la Ricerca sul Cancro di Genova | Genoa | Liguria | 16132 | Italy |
| Irccs Ospedale San Raffaele;Oncologia Medica | Milan | Lombardy | 20132 | Italy |
| Istituto Europeo Di Oncologia | Milan | Lombardy | 20141 | Italy |
| ASST DI MONZA; Oncologia Medica | Monza | Lombardy | 20900 | Italy |
| POLICLINICO RODOLICO, U.O. di Oncologia Medica | Catania | Sicily | 95100 | Italy |
| Ospedale San Luca; Oncologia | Lucca | Tuscany | 55100 | Italy |
| A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii | Pisa | Tuscany | 56124 | Italy |
| IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda | Padova | Veneto | 35128 | Italy |
| A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina | Verona | Veneto | 37134 | Italy |
| Aichi Cancer Center Hospital; Respiratory Medicine | Aichi | 464-8681 | Japan |
| National Cancer Center Hospital East; Thoracic Oncology | Chiba | 277-8577 | Japan |
| National Hospital Organization Shikoku Cancer Center; Internal Medicine | Ehime | 791-0280 | Japan |
| National Hospital Organization Kyushu Cancer Center, Thoracic Oncology | Fukuoka | 811-1395 | Japan |
| Kobe City Medical Center General Hospital; Respiratory Medicine | Hyōgo | 650-0047 | Japan |
| Hyogo Cancer Center; Thoracic Oncology | Hyōgo | 673-8558 | Japan |
| Miyagi Cancer Center; Respiratory Medicine | Miyagi | 981-1293 | Japan |
| Okayama University Hospital; Respiratory and Allergy Medicine | Okayama | 700-8558 | Japan |
| Kindai University Hospital; Medical Oncology | Osaka | 589-8511 | Japan |
| National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine | Osaka | 591-8555 | Japan |
| Saitama Cancer Center; Thoracic Oncology | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center; Thoracic Oncology | Shizuoka | 411-8777 | Japan |
| National Cancer Center Hospital; Thoracic Medical Oncology | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital of JFCR, Respiratory Medicine | Tokyo | 135-8550 | Japan |
| Tokyo Medical University Hospital; Dept of Surgery | Tokyo | 160-0023 | Japan |
| National Hospital Organization, Yamaguchi - Ube Medical Center; Oncology Medicine | Yamaguchi | 755-0241 | Japan |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | 5223 GZ | Netherlands |
| Catharina Ziekenhuis; Dept of Lung Diseases | Eindhoven | 5623 EJ | Netherlands |
| Antonius Ziekenhuis; Dept of Lung Diseases | Nieuwegein | 3435 CM | Netherlands |
| Auckland city hospital; Auckland Regional Cancer Centre and Blood Service | Auckland | 1023 | New Zealand |
| Dunedin Hospital | Dunedin | New Zealand |
| Waikato Hospital; Dept of Medical Oncology | Hamilton | 3240 | New Zealand |
| Oslo Universitetssykehus HF; Radiumhospitalet | Oslo | 0310 | Norway |
| Centro Hemato Oncologico Panama | Panama City | 0832 | Panama |
| Medical University of Gdansk | Gdansk | 80-952 | Poland |
| Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii | Lodz | 93-513 | Poland |
| Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii | Otwock | 05-400 | Poland |
| Med.-Polonia Sp. z o.o. NSZOZ | Poznan | 60-693 | Poland |
| Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii | Warsaw | 02-781 | Poland |
| Hospital Geral; Servico de Pneumologia | Coimbra | 3041-801 | Portugal |
| Hospital Pulido Valente; Servico de Pneumologia | Lisbon | 1796-001 | Portugal |
| IPO do Porto; Servico de Oncologia Medica | Porto | 4200-072 | Portugal |
| N.N.Burdenko Main Military Clinical Hospital; Oncology Dept | Moscow | 105229 | Russia |
| City Clinical Onc. | Saint Petersburg | 198255 | Russia |
| SBI of Healthcare Samara Regional Clinical Oncology Dispensary | Samara | 443031 | Russia |
| Clinic for Pulmonology, Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| Institute for pulmonary diseases of Vojvodina | Kamenitz | 21204 | Serbia |
| National Cancer Center; Medical Oncology | Gyeonggi-do | 410-769 | South Korea |
| Seoul National University Bundang Hospital; Hematology Medical Oncology | Gyeonggi-do | 463-707 | South Korea |
| Seoul National Uni Hospital; Internal Medicine | Seoul | 03080 | South Korea |
| Yonsei University Severance Hospital; Medical Oncology | Seoul | 120-752 | South Korea |
| Samsung Medical Center; Gastroenterology | Seoul | 135-710 | South Korea |
| Seoul St.Mary's Hospital; Medical Oncology | Seoul | 137-807 | South Korea |
| Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia | Las Palmas de Gran Canaria | LAS Palmas | 35016 | Spain |
| Hospital Universitario Puerta de Hierro; Servicio de Oncologia | Majadahonda | Madrid | 28222 | Spain |
| Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología | A Coruña | 15006 | Spain |
| Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | 28034 | Spain |
| Fundacion Jimenez Diaz; Servicio de Oncologia | Madrid | 28040 | Spain |
| Hospital Universitario Clínico San Carlos; Servicio de Oncologia | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | 28041 | Spain |
| Hospital Universitario La Paz; Servicio de Oncologia | Madrid | 28046 | Spain |
| Hospital Regional Universitario Carlos Haya; Servicio de Oncologia | Málaga | 29010 | Spain |
| Hospital Universitario Miguel Servet; Servicio Oncologia | Zaragoza | 50009 | Spain |
| Sahlgrenska Universitetssjukhuset, Lungmedicinkliniken | Gothenburg | 41345 | Sweden |
| Universitetssjukhuset Linköping; Lungmedicinkliniken | Linköping | 581 85 | Sweden |
| Karolinska Universitetssjukhuset, Solna; Lung Allergikliniken N10:02 | Stockholm | 171 76 | Sweden |
| Kantonsspital Baden; Medizinische Klinik, Onkologie | Baden | 5404 | Switzerland |
| HUG; Oncologie | Geneva | 1211 | Switzerland |
| Luzerner Kantonsspital; Medizinische Onkologie | Lucerne | 6004 | Switzerland |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| National Taiwan Uni Hospital; Internal Medicine | Taipei | 100 | Taiwan |
| Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology | Taipei | 112 | Taiwan |
| Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology | Taoyuan | 333 | Taiwan |
| Chulalongkorn Hospital; Medical Oncology | Bangkok | 10330 | Thailand |
| Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc | Bangkok | 10400 | Thailand |
| Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology | Bangkok | 10700 | Thailand |
| Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology | Istanbul | 34300 | Turkey (Türkiye) |
| Izmir Suat Seren Chest Diseases and Surgery Research Hospital | Izmir | 35110 | Turkey (Türkiye) |
| State Medical Academy; Oncology | Dnipropetrovsk | 43102 | Ukraine |
| Karkiv Regional Oncology Center | Kharkiv | 61070 | Ukraine |
| Uzhgorod Nat. University Central Municip Hosp; Onc Center | Uzhhorod | 88000 | Ukraine |
| Diana Princess of Wales Hosp. | Grimsby | DN33 2BA | United Kingdom |
| University College London Hospital | London | NW1 - 2PG | United Kingdom |
| Royal Free Hospital | London | NW3 2QS | United Kingdom |
| Guys and St Thomas NHS Foundation Trust, Guys Hospital | London | SE1 9RT | United Kingdom |
| St George's Hospital | London | SW17 0QT | United Kingdom |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| Christie Hospital NHS Trust | Manchester | M20 4BX | United Kingdom |
| Kings Mill Hospital | Sutton in Ashfield | NG17 4JL | United Kingdom |
| Derived |
| Mhatre SK, Machado RJM, Ton TGN, Trinh H, Mazieres J, Rittmeyer A, Bretscher MT. Real-World Progression-Free Survival as an Endpoint in Lung Cancer: Replicating Atezolizumab and Docetaxel Arms of the OAK Trial Using Real-World Data. Clin Pharmacol Ther. 2023 Dec;114(6):1313-1322. doi: 10.1002/cpt.3045. Epub 2023 Sep 28. |
| 37004206 | Derived | Saal J, Bald T, Eckstein M, Ritter M, Brossart P, Ellinger J, Holzel M, Klumper N. Early C-reactive protein kinetics predicts immunotherapy response in non-small cell lung cancer in the phase III OAK trial. JNCI Cancer Spectr. 2023 Mar 1;7(2):pkad027. doi: 10.1093/jncics/pkad027. |
| 36428744 | Derived | Dong Y, Zhu Y, Zhuo M, Chen X, Xie Y, Duan J, Bai H, Hao S, Yu Z, Yi Y, Guan Y, Yuan J, Xia X, Yi X, Wang J, Wang Z. Maximum Somatic Allele Frequency-Adjusted Blood-Based Tumor Mutational Burden Predicts the Efficacy of Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer. Cancers (Basel). 2022 Nov 17;14(22):5649. doi: 10.3390/cancers14225649. |
| 35727053 | Derived | Cortellini A, Ricciuti B, Borghaei H, Naqash AR, D'Alessio A, Fulgenzi CAM, Addeo A, Banna GL, Pinato DJ. Differential prognostic effect of systemic inflammation in patients with non-small cell lung cancer treated with immunotherapy or chemotherapy: A post hoc analysis of the phase 3 OAK trial. Cancer. 2022 Aug 15;128(16):3067-3079. doi: 10.1002/cncr.34348. Epub 2022 Jun 21. |
| 34226144 | Derived | Gadgeel S, Hirsch FR, Kerr K, Barlesi F, Park K, Rittmeyer A, Zou W, Bhatia N, Koeppen H, Paul SM, Shames D, Yi J, Matheny C, Ballinger M, McCleland M, Gandara DR. Comparison of SP142 and 22C3 Immunohistochemistry PD-L1 Assays for Clinical Efficacy of Atezolizumab in Non-Small Cell Lung Cancer: Results From the Randomized OAK Trial. Clin Lung Cancer. 2022 Jan;23(1):21-33. doi: 10.1016/j.cllc.2021.05.007. Epub 2021 May 30. |
| 33737340 | Derived | Gandara D, Reck M, Moro-Sibilot D, Mazieres J, Gadgeel S, Morris S, Cardona A, Mendus D, Ballinger M, Rittmeyer A, Peters S. Fast progression in non-small cell lung cancer: results from the randomized phase III OAK study evaluating second-line atezolizumab versus docetaxel. J Immunother Cancer. 2021 Mar;9(3):e001882. doi: 10.1136/jitc-2020-001882. |
| 33241650 | Derived | Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685. |
| 32115349 | Derived | Chalabi M, Cardona A, Nagarkar DR, Dhawahir Scala A, Gandara DR, Rittmeyer A, Albert ML, Powles T, Kok M, Herrera FG; imCORE working group of early career investigators. Efficacy of chemotherapy and atezolizumab in patients with non-small-cell lung cancer receiving antibiotics and proton pump inhibitors: pooled post hoc analyses of the OAK and POPLAR trials. Ann Oncol. 2020 Apr;31(4):525-531. doi: 10.1016/j.annonc.2020.01.006. Epub 2020 Jan 16. |
| 31542806 | Derived | Morrissey KM, Marchand M, Patel H, Zhang R, Wu B, Phyllis Chan H, Mecke A, Girish S, Jin JY, Winter HR, Bruno R. Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting. Cancer Chemother Pharmacol. 2019 Dec;84(6):1257-1267. doi: 10.1007/s00280-019-03954-8. Epub 2019 Sep 21. |
| 30642441 | Derived | Gadgeel SM, Lukas RV, Goldschmidt J, Conkling P, Park K, Cortinovis D, de Marinis F, Rittmeyer A, Patel JD, von Pawel J, O'Hear C, Lai C, Hu S, Ballinger M, Sandler A, Gandhi M, Fehrenbacher L. Atezolizumab in patients with advanced non-small cell lung cancer and history of asymptomatic, treated brain metastases: Exploratory analyses of the phase III OAK study. Lung Cancer. 2019 Feb;128:105-112. doi: 10.1016/j.lungcan.2018.12.017. Epub 2018 Dec 19. |
| 30017645 | Derived | Bordoni R, Ciardiello F, von Pawel J, Cortinovis D, Karagiannis T, Ballinger M, Sandler A, Yu W, He P, Matheny C, Felizzi F, Rittmeyer A. Patient-Reported Outcomes in OAK: A Phase III Study of Atezolizumab Versus Docetaxel in Advanced Non-Small-cell Lung Cancer. Clin Lung Cancer. 2018 Sep;19(5):441-449.e4. doi: 10.1016/j.cllc.2018.05.011. Epub 2018 May 31. |
| 29525239 | Derived | Hida T, Kaji R, Satouchi M, Ikeda N, Horiike A, Nokihara H, Seto T, Kawakami T, Nakagawa S, Kubo T. Atezolizumab in Japanese Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer: A Subgroup Analysis of the Phase 3 OAK Study. Clin Lung Cancer. 2018 Jul;19(4):e405-e415. doi: 10.1016/j.cllc.2018.01.004. Epub 2018 Feb 1. |
| 27979383 | Derived | Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J, Gadgeel SM, Hida T, Kowalski DM, Dols MC, Cortinovis DL, Leach J, Polikoff J, Barrios C, Kabbinavar F, Frontera OA, De Marinis F, Turna H, Lee JS, Ballinger M, Kowanetz M, He P, Chen DS, Sandler A, Gandara DR; OAK Study Group. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017 Jan 21;389(10066):255-265. doi: 10.1016/S0140-6736(16)32517-X. Epub 2016 Dec 13. |
Atezolizumab 1200 milligrams (mg) was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
SP-Intent to Treat (ITT) analysis set included all randomized ITT participants regardless of whether they received any study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Docetaxel | Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
| BG001 | Atezolizumab | Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
| BG002 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | SP-ITT Population | Number | 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 | Percentage of Participants Who Died: PP-ITT | PP-ITT analysis set included the first 850 randomized ITT participants regardless of whether they received any study drug. | Posted | Number | Percentage of Participants | Baseline until death due to any cause (up to approximately 2.25 years) |
|
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| Primary | Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP | Percentage of participants who died among TC1/2/3 or IC1/2/3 subgroup of PP-ITT were reported. TC1 = presence of discernible programmed death-ligand 1 (PD-L1) staining of any intensity in >/=1% and <5% TCs; TC2: presence of discernible PD-L1 staining of any intensity in >/=5% and <50% TCs; TC3 = presence of discernible PD-L1 staining of any intensity in >/=50% TCs; IC1 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=1% and <5% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC2 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=5% and <10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC3 = presence of discernible PD-L1 staining of any intensity in ICs covering >/=10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma. | TC1/2/3 or IC1/2/3 subgroup within PP included ITT participants with the corresponding programmed death-ligand 1 (PD-L1) expression status. | Posted | Number | Percentage of Participants | Baseline until death due to any cause (up to approximately 2.25 years) |
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| Primary | Overall Survival (OS): PP-ITT | OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology. | The PP-ITT analysis set. | Posted | Median | 95% Confidence Interval | Months | Baseline until death due to any cause (up to approximately 2.25 years) |
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| Primary | OS: TC1/2/3 or IC1/2/3 Subgroup of PP | OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology. | TC1/2/3 or IC1/2/3 subgroup of PP | Posted | Median | 95% Confidence Interval | Months | Baseline until death due to any cause (up to approximately 2.25 years) |
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| Secondary | Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT | PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeters (mm), or presence of new lesions. | The PP-ITT analysis set | Posted | Number | Percentage of Participants | Baseline up to PD or Death (up to approximately 2.25 years) |
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| Secondary | Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP | PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions. | TC1/2/3 or IC1/2/3 subgroup of PP | Posted | Number | Percentage of Participants | Baseline up to PD or Death (up to approximately 2.25 years) |
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| Secondary | Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT | PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions. | The PP-ITT analysis set. | Posted | Median | 95% Confidence Interval | Months | Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years) |
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| Secondary | PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP | PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions. | The TC1/2/3 or IC1/2/3 subgroup of PP | Posted | Median | 95% Confidence Interval | Months | Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years) |
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| Secondary | Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT | Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions. | The PP-ITT analysis set. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years) |
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| Secondary | Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP | Objective response is defined as a CR or PR as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions. | The TC1/2/3 or IC1/2/3 subgroup of PP | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years) |
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| Secondary | Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT | DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology. | The PP-ITT analysis set. | Posted | Median | 95% Confidence Interval | Months | From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years) |
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| Secondary | DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP | DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology. | The TC1/2/3 or IC1/2/3 subgroup of PP | Posted | Median | 95% Confidence Interval | Months | From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years) |
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| Secondary | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab | ATA evaluable population included all participants who received atezolizumab treatment and had at least one post treatment ATA result. | Posted | Number | Percentage of Participants | Baseline up to approximately 2.25 years (assessed at predose [Hour {Hr} 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, then every 8 cycles up to end of treatment (EOT) [approximately 2.25 years]; 120 days after EOT [approximately 2.25 years] [1 Cycle=21 days]) |
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| Secondary | Maximum Observed Serum Atezolizumab Concentration (Cmax) | Pharmacokinetic (PK) evaluable population included participants who received atezolizumab treatment and had at least one measurable PK concentration. | Posted | Mean | Standard Deviation | Microgram per milliliter (mcg/mL) | Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days) |
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| Secondary | Minimum Observed Serum Atezolizumab Concentration (Cmin) | PK evaluable participants. Here, 'n' signifies those participants evaluated for this measure at specific time point. All 606 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number. | Posted | Mean | Standard Deviation | mcg/mL | Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days) |
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| Secondary | Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13) | TTD in patient-reported lung cancer symptoms (pain in chest or in arm/shoulder, dyspnea, or cough) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the symptoms. A >/=10-point change in the score perceived by participants was considered as clinically significant. The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity. | The PP-ITT analysis set. | Posted | Median | 95% Confidence Interval | Months | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days) |
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| Secondary | EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items | EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement). | The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
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| Secondary | EORTC QLQ-C30 Questionnaire Score: Functional Subscales | EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement). | The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
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| Secondary | EORTC QLQ-C30 Questionnaire Score: GHS Scale | EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement). | The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
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| Secondary | EORTC QLQ-C30 Questionnaire Score: Symptom Subscale | EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement). | The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
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| Secondary | EORTC QLQ-LC13 Questionnaire Score: Alopecia | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for alopecia. | The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
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| Secondary | EORTC QLQ-LC13 Questionnaire Score: Coughing | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for coughing. | The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
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| Secondary | EORTC QLQ-LC13 Questionnaire Score: Dysphagia | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dysphagia. | The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
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| Secondary | EORTC QLQ-LC13 Questionnaire Score: Dyspnea | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dyspnea. | The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
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| Secondary | EORTC QLQ-LC13 Questionnaire Score: Hemoptysis | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for hemoptysis. | The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
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| Secondary | EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in arm or shoulder. | The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
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| Secondary | EORTC QLQ-LC13 Questionnaire Score: Pain in Chest | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in chest. | The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
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| Secondary | EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for peripheral neuropathy. | The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
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| Secondary | EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in other parts. | The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
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| Secondary | EORTC QLQ-LC13 Questionnaire Score: Sore Mouth | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for sore mouth. | The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days) |
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| Primary | OS: SP-ITT | OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology. | Secondary population (SP) ITT analysis set included all 1225 randomized participants regardless of whether they received any study drug. | Posted | Median | 95% Confidence Interval | Months | Baseline until death due to any cause (up to approximately 2.87 years) |
| ||||||||||||||||||||||||||||||
| Primary | OS: TC1/2/3 Or IC1/2/3 Subgroup of SP | OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology. | TC1/2/3 Or IC1/2/3 Subgroup of SP. | Posted | Median | 95% Confidence Interval | Months | Baseline until death from any cause (approximately 2.87 years) |
|
| |||||||||||||||||||||||||||||
| Primary | OS: TC2/3 or IC2/3 Subgroup of SP | OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology. | TC2/3 or IC2/3 Subgroup of SP. | Posted | Median | 95% Confidence Interval | Months | Baseline until death due to any cause (up to approximately 2.87 years) |
|
| |||||||||||||||||||||||||||||
| Primary | OS: TC3 or IC3 Subgroup of SP | OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology. | TC3 or IC3 Subgroup of SP. | Posted | Median | 95% Confidence Interval | Months | Baseline until death due to any cause (up to approximately 2.87 years) |
|
| |||||||||||||||||||||||||||||
| Secondary | PFS as Determined by Investigator Using RECIST v1.1: SP-ITT | PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions. | SP-ITT analysis set. | Posted | Median | 95% Confidence Interval | Months | Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT | Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions. | SP-ITT analysis set. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years) |
| ||||||||||||||||||||||||||||||
| Secondary | DOR as Determined by Investigator Using RECIST v1.1: SP ITT | DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology. | The SP-ITT analysis set. | Posted | Median | 95% Confidence Interval | Months | From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years) |
|
Baseline up to approximately 5.28 years.
Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
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 | Docetaxel | Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. | 180 | 578 | 535 | 578 | ||
| EG001 | Atezolizumab | Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. | 200 | 609 | 541 | 609 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Tachycardia paroxysmal | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Retinopathy | Eye disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Duodenal perforation | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Oesophageal fistula | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Gastrointestinal fungal infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pleural infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Burns third degree | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
| |
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | Non-systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Cerebral artery embolism | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Cerebral thrombosis | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Henoch-Schonlein purpura nephritis | Renal and urinary disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pleural fistula | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Fracture displacement | Injury, poisoning and procedural complications | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Mental status change | Psychiatric disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA v22.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v22.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
|
|
|
| Asian |
|
|
| Black or African American |
|
|
| Native Hawaiian or other Pacific Islander |
|
|
| White |
|
|
| Other |
|
|
| Multiple |
|
|
| Unknown |
|
|
| OG001 | Atezolizumab | Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
|
|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
|
|
|
| Atezolizumab |
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
|
|
|
|
|
|
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
|
|
|
| OG001 | Atezolizumab | Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
|
|
| OG001 | Atezolizumab | Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
|
|
| OG001 | Atezolizumab | Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
|
|
| OG001 | Atezolizumab | Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
|
|
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
|
|
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
|
|
| Atezolizumab |
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
|
|
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
|
|
| Atezolizumab |
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
|
|
| Atezolizumab |
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
|
|
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
|
|
| Atezolizumab |
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
|
|
| Atezolizumab |
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
|
|
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. |
|
|
|