| Primary | Overall Survival (OS) in PD-L1-positive Population | OS was defined as time from randomization to death from any cause. Participants without a reported death event at the time of the analysis were censored on the date they were last known to be alive. If no post-baseline data were available, OS was censored at the date of randomization +1 day. | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | Posted | | Median | 95% Confidence Interval | months | | Time from randomization to death (Up to 68 months) | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. | | OG001 | Atezolizumab + Chemotherapy | Participants received atezolizumab 1200 mg, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle = 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00011.24(9.00 to 13.31)
- OG00112.09(10.12 to 15.08)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Log Rank | | 0.5891 | | Hazard Ratio (HR) | 0.93 | | | 2-Sided | 95 | 0.73 | 1.20 | | | | | Superiority | | |
|
| Primary | OS in Modified Intent-to-treat (mITT) Population | OS was defined as time from randomization to death from any cause. Participants without a reported death event at the time of the analysis were censored on the date they were last known to be alive. If no post-baseline data were available, OS was censored at the date of randomization +1 day. | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | Posted | | Median | 95% Confidence Interval | months | | Time from randomization to death (Up to 68 months) | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. | | OG001 | Atezolizumab + Chemotherapy | Participants received atezolizumab 1200 mg, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle = 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
|
| Secondary | 12-month Survival Rate in PD-L1-positive Population | 12-month survival rate was defined as the percentage of participants alive 12 months after randomization. The 12-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to the nearest whole number. | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. | | OG001 | Atezolizumab + Chemotherapy | Participants received atezolizumab 1200 mg, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle = 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
|
| Secondary | 12-month Survival Rate in mITT Population | 12-month survival rate was defined as the percentage of participants alive 12 months after randomization. The 12-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to nearest whole number. | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. | | OG001 | Atezolizumab + Chemotherapy | Participants received atezolizumab 1200 mg, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle = 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
|
| Secondary | 18-month Survival Rate in PD-L1-positive Population | 18-month survival rate was defined as the percentage of participants alive 18 months after randomization. The 18-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to nearest whole number. | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. | | OG001 | Atezolizumab + Chemotherapy | Participants received atezolizumab 1200 mg, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle = 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
|
| Secondary | 18-month Survival Rate in mITT Population | 18-month survival rate was defined as the percentage of participants alive 18 months after randomization. The 18-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to nearest whole number. | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. | | OG001 | Atezolizumab + Chemotherapy | Participants received atezolizumab 1200 mg, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle = 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
|
| Secondary | Progression-free Survival (PFS) in PD-L1-positive Population | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 millimeters (mm). Data for participants not experiencing PD or death were censored at the last tumour assessment date. If no tumor assessment was performed after randomisation, data were censored at the date of randomisation +1 day. | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | Posted | | Median | 95% Confidence Interval | months | | Time from randomization to the first occurrence of PD or death (Up to 68 months) | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
|
| Secondary | PFS in mITT Population | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Data for participants not experiencing PD or death were censored at the last tumour assessment date. If no tumor assessment was performed after randomisation, data were censored at the date of randomisation +1 day. | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | Posted | | Median | 95% Confidence Interval | months | | Time from randomization to the first occurrence of PD or death (Up to 68 months) | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
|
| Secondary | Objective Response Rate (ORR) in Response-evaluable Population, Subset of PD-L1-positive Population | ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented unconfirmed objective response (OR). OR was defined as either a complete response (CR) or a partial response (PR), as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number. | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. Response-evaluable Population included participants randomized in the study with measurable disease at baseline. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline up to end of study (Up to 68 months) | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
|
| Secondary | ORR in Response-evaluable Population, Subset of mITT Population | ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented unconfirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number. | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1 (SP142)-positive and PD-L1 (SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. Response-evaluable Population included participants randomized in the study with measurable disease at baseline. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline up to end of study (Up to 68 months) | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
|
| Secondary | Duration of Objective Response (DoR) in DoR-evaluable Population Subset of PD-L1-positive Population | DoR was defined as the time from the first occurrence of a documented unconfirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. DOR-evaluable population included participants randomized in the study with measurable disease at baseline and an OR. | Posted | | Median | 95% Confidence Interval | months | | Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months) | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
|
| Secondary | DoR in DoR-evaluable Population Subset of mITT Population | DoR was defined as the time from the first occurrence of a documented unconfirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. DOR-evaluable population included participants randomized in the study with measurable disease at baseline and an OR. | Posted | | Median | 95% Confidence Interval | months | | Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months) | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
|
| Secondary | Clinical Benefit Rate (CBR) in Response-evaluable Population Subset of PD-L1-positive Population | CBR was defined as the percentage of participants with either an unconfirmed CR or PR or stable disease (SD) that lasts at least 6 months as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Percentages have been rounded off to nearest whole number. | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating immune cells IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. Response-evaluable population included participants randomized in the study with measurable disease at baseline. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 68 months | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
|
| Secondary | CBR in Response-evaluable Population Subset of mITT Population | CBR was defined as the percentage of participants with either an unconfirmed CR or PR or SD that lasts at least 6 months as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Percentages have been rounded off to nearest whole number. | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. Response-evaluable population included participants randomized in the study with measurable disease at baseline. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 68 months | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
|
| Secondary | Confirmed Objective Response Rate (C-ORR) in Response-evaluable Population Subset of PD-L1-positive Population | C-ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented confirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number. | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. Response-evaluable population included participants randomized in the study with measurable disease at baseline. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 68 months | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
|
| Secondary | C-ORR in Response-evaluable Population Subset of mITT Population | C-ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented confirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number. | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. Response-evaluable population included participants randomized in the study with measurable disease at baseline. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 68 months | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
|
| Secondary | DoR for Confirmed Responders (C-DoR) in C-DoR-evaluable Population Subset of PD-L1-positive Population | C-DoR was defined as the time from the first occurrence of a documented confirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. | PD-L1 population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. C-DOR-evaluable population included participants randomized in the study with measurable disease at baseline and a confirmed OR. | Posted | | Median | 95% Confidence Interval | months | | Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months) | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
|
| Secondary | C-DoR in C-DoR-evaluable Population Subset of mITT Population | C-DoR was defined as the time from the first occurrence of a documented confirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. C-DOR-evaluable population included participants randomized in the study with measurable disease at baseline and a confirmed OR. | Posted | | Median | 95% Confidence Interval | months | | Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months) | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
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| Secondary | Time to Confirmed Deterioration (TTD) in Global Health Status/Quality of Life (GHS/QoL) According to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) in PD-L1-positive Population | TTD in GHS/QoL, defined by a minimally important decrease of ≥10 points at 2 consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of EORTC QLQ-C30, which consists of 30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, & six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Participant responses to questions regarding GHS (Question 29: GHS; "How would you rate your overall health during the past week?") & QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were assessed & were scored on a 7-point scale (1= Very poor; 7=Excellent). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better QoL. | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | Posted | | Median | 95% Confidence Interval | months | | Up to 68 months | | | | ID | Title | Description |
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| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
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| Secondary | TTD in GHS/QoL According to EORTC QLQ-C30 in mITT Population | TTD in GHS/QoL, defined by a minimally important decrease of ≥10 points at 2 consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of EORTC QLQ-C30, which consists of 30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, & six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Participant responses to questions regarding GHS (Question 29: GHS; "How would you rate your overall health during the past week?") & QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were assessed & were scored on a 7-point scale (1= Very poor; 7=Excellent). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better QoL. | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | Posted | | Median | 95% Confidence Interval | months | | Up to 68 months | | | | ID | Title | Description |
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| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
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| Secondary | Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions that worsen during a study are also considered AEs. | Safety-evaluable population included participants who received any amount of any study drug (atezolizumab/placebo or chemotherapy). | Posted | | Count of Participants | | Participants | | From treatment initiation up to 90 days after last dose (up to 71 months) | | | | ID | Title | Description |
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| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. | | OG001 | Atezolizumab + Chemotherapy | Participants received atezolizumab 1200 mg, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle = 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
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| Secondary | Serum Concentration of Atezolizumab | | Pharmacokinetic (PK)-evaluable population included participants who received any dose of study medication and who had at least one evaluable post-baseline PK sample. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | micrograms/millilitre (µg/mL) | | Pre-dose on Day 1 of Cycles 1, 2, 3 and 4; Post-dose on Day 1 of Cycles 1 and 3 and Treatment Discontinuation Visit (up to 69 months) (1 Cycle= 3 weeks) | | | | ID | Title | Description |
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| OG000 | Atezolizumab + Chemotherapy | Participants received atezolizumab 1200 mg, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle = 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
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| Secondary | Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab | Number of ADA-positive participants after drug administration was determined for participants exposed to atezolizumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result. The sum of participants who were ADA-positive at postbaseline visits of Cycles 1 to 4 and treatment discontinuation has been reported here. | Safety-evaluable population included participants who received any amount of any study drug (atezolizumab/placebo or chemotherapy). Overall number analyzed included participants with data available for analysis. | Posted | | Count of Participants | | Participants | | Cycles 1 to 4 and Treatment Discontinuation visit (up to 69 months) | | | | ID | Title | Description |
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| OG000 | Atezolizumab + Chemotherapy | Participants received atezolizumab 1200 mg, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle = 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
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| Secondary | Number of Participants With PD-L1 Protein Expression in Screening Tumour Tissue and Post-baseline Assessment | | FAS population included all participants randomized in the study, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | Posted | | Count of Participants | | Participants | | Baseline up to 68 months | | | | ID | Title | Description |
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| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. | | OG001 | Atezolizumab + Chemotherapy | Participants received atezolizumab 1200 mg, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle = 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
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| Other Pre-specified | OS in China Population | OS was defined as time from randomization to death from any cause. | As pre-specified in the SAP, analysis for China population was to be conducted based on data maturity and the estimated treatment effect from the global population. As the results for global population did not meet pre-specified criteria, a separate analysis for China subpopulation was not conducted. | Posted | | | | | | Time from randomization to death (Up to 68 months) | | | | ID | Title | Description |
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| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. | | OG001 | Atezolizumab + Chemotherapy | Participants received atezolizumab 1200 mg, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle = 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
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| Other Pre-specified | 12-month Survival Rate in China Population | 12-month survival rate was defined as the percentage of participants alive 12 months after randomization. | As pre-specified in the SAP, analysis for China population was to be conducted based on data maturity and estimated treatment effect from the global population. As the results for global population did not meet pre-specified criteria, a separate analysis for China subpopulation was not conducted. | Posted | | | | | | 12 months | | | | ID | Title | Description |
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| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. | | OG001 | Atezolizumab + Chemotherapy | Participants received atezolizumab 1200 mg, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle = 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
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| Other Pre-specified | 18-month Survival Rate in China Population | 18-month survival rate was defined as the percentage of participants alive 18 months after randomization. | As pre-specified in the SAP, analysis for China population was to be conducted based on data maturity and estimated treatment effect from the global population. As the results for the global population did not meet pre-specified criteria, a separate analysis for China subpopulation was not conducted. | Posted | | | | | | 18 months | | | | ID | Title | Description |
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| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. | | OG001 | Atezolizumab + Chemotherapy | Participants received atezolizumab 1200 mg, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle = 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
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| Other Pre-specified | PFS in China Population | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST 1.1, or death from any cause, whichever occurs first. | As pre-specified in the SAP, analysis for China population was to be conducted based on data maturity and estimated treatment effect from the global population. As the results for the global population did not meet pre-specified criteria, a separate analysis for China subpopulation was not conducted. | Posted | | | | | | Time from randomization to the first occurrence of PD or death (Up to 68 months) | | | | ID | Title | Description |
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| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. | | OG001 | Atezolizumab + Chemotherapy | Participants received atezolizumab 1200 mg, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle = 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
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| Other Pre-specified | ORR in China Population | ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented unconfirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. | As pre-specified in the SAP, analysis for China population was to be conducted based on data maturity and estimated treatment effect from the global population. As the results for the global population were did not meet pre-specified criteria, a separate analysis for China subpopulation was not conducted. | Posted | | | | | | Baseline up to end of study (Up to 68 months) | | | | ID | Title | Description |
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| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. | | OG001 | Atezolizumab + Chemotherapy | |
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| Other Pre-specified | DoR in China Population | DoR was defined as the time from the first occurrence of a documented unconfirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. | As pre-specified in the SAP, analysis for China population was to be conducted based on data maturity and estimated treatment effect from the global population. As the results for the global population were did not meet pre-specified criteria, a separate analysis for China subpopulation was not conducted. | Posted | | | | | | Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months) | | | | ID | Title | Description |
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| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
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| Other Pre-specified | CBR in China Population | CBR was defined as the percentage of participants with either an unconfirmed CR or PR or SD that lasts at least 6 months as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. | As pre-specified in the SAP, analysis for China population was to be conducted based on data maturity and estimated treatment effect from the global population. As the results for the global population were did not meet pre-specified criteria, a separate analysis for China subpopulation was not conducted. | Posted | | | | | | Up to 68 months | | | | ID | Title | Description |
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| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
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| Other Pre-specified | C-ORR in China Population | C-ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented confirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. | As pre-specified in the SAP, analysis for China population was to be conducted based on data maturity and estimated treatment effect from the global population. As the results for the global population were did not meet pre-specified criteria, a separate analysis for China subpopulation was not conducted. | Posted | | | | | | Up to 68 months | | | | ID | Title | Description |
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| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. | | OG001 | Atezolizumab + Chemotherapy | Participants received atezolizumab 1200 mg, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle = 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
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| Other Pre-specified | C-DoR in China Population | C-DoR was defined as the time from the first occurrence of a documented confirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. | As pre-specified in the SAP, analysis for China population was to be conducted based on data maturity and estimated treatment effect from the global population. As the results for the global population did not meet pre-specified criteria, a separate analysis for China subpopulation was not conducted. | Posted | | | | | | Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months) | | | | ID | Title | Description |
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| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
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| Other Pre-specified | TTD in GHS/QoL According to EORTC QLQ-C30 in China Population | TTD in GHS/QoL, defined by a minimally important decrease of ≥10 points at 2 consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of EORTC QLQ-C30, which consists of 30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, & six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Participant responses to questions regarding GHS (Question 29: GHS; "How would you rate your overall health during the past week?") & QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were assessed & were scored on a 7-point scale (1= Very poor; 7=Excellent). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better QoL. | As pre-specified in the SAP, analysis for China population was to be conducted based on data maturity and estimated treatment effect from the global population. As the results for the global population did not meet pre-specified criteria, a separate analysis for China subpopulation was not conducted. | Posted | | | | | | Up to 68 months | | | | ID | Title | Description |
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| OG000 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. |
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