Trial Outcomes & Findings for Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer (NCT NCT02027428)

NCT ID: NCT02027428

Last Updated: 2020-08-17

Results Overview

Progression-free survival is defined as the time in months from the date of randomization to the date of disease progression based on the investigator's assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by computerized axial tomography \[CT scan\], not including symptomatic deterioration) or death (any cause) on or prior to 01 Aug 2019. RECIST 1.1 Definition: - Complete response (CR) -disappearance of all target lesions; - Partial response (PR) -at least a 30% decrease in the sum of diameters of target lesions from baseline - Stable disease (SD) -neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase of lesions to qualify for progressive disease (PD) - Progressive Disease (PD) - At least a 20% increase in the sum of diameters of target lesions from nadir, and/or the appearance of new lesions.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

427 participants

Primary outcome timeframe

From the date of randomization to the date of disease progression or death of any cause; up to data cut off date of 15 September 2017; up to 27.6 months

Results posted on

2020-08-17

Participant Flow

The study was conducted at 87 sites in Germany, Italy, Spain, the United Kingdom and the United States.

Participants with a response or stable disease during Induction were randomised 2:1 into investigative treatment (nab-paclitaxel plus best supportive care \[BSC\] or BSC only) stratified by disease stage, response during induction and Eastern Cooperative Oncology Group (ECOG) performance status.

Participant milestones

Participant milestones
Measure	All Participants - Induction During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m\^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg\*min/mL IV on Day 1 of each 21-day cycle. If the participant had radiological or clinical progressive disease (PD), they were discontinued from the study and not followed. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she were eligible to be randomised to the maintenance phase	Nab-Paclitaxel + Best Supportive Care (BSC) Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.	Best Supportive Care (BSC) Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.
Induction STARTED	427	0	0
Induction Received Study Drug	420	0	0
Induction COMPLETED	202	0	0
Induction NOT COMPLETED	225	0	0
Maintenance STARTED	0	136	66
Maintenance COMPLETED	0	12	6
Maintenance NOT COMPLETED	0	124	60
Survival Follow-up STARTED	0	117	55
Survival Follow-up COMPLETED	0	38	9
Survival Follow-up NOT COMPLETED	0	79	46

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants - Induction During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m\^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg\*min/mL IV on Day 1 of each 21-day cycle. If the participant had radiological or clinical progressive disease (PD), they were discontinued from the study and not followed. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she were eligible to be randomised to the maintenance phase	Nab-Paclitaxel + Best Supportive Care (BSC) Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.	Best Supportive Care (BSC) Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.
Induction Never treated	7	0	0
Induction Progressive disease	77	0	0
Induction Adverse Event	51	0	0
Induction Withdrawal by Subject	22	0	0
Induction Death	21	0	0
Induction Symptomatic deterioration	16	0	0
Induction Study terminated by sponsor	12	0	0
Induction Protocol Violation	1	0	0
Induction Miscellaneous	14	0	0
Induction Induction Treatment Ongoing	4	0	0
Maintenance Death	0	3	2
Maintenance Adverse Event	0	21	1
Maintenance Progressive disease	0	84	47
Maintenance Symptomatic deterioration	0	4	1
Maintenance Withdrawal by Subject	0	6	5
Maintenance Protocol Violation	0	0	1
Maintenance Other	0	6	3
Survival Follow-up Death	0	78	45
Survival Follow-up Lost to Follow-up	0	1	1

Baseline Characteristics

Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nab-Paclitaxel + Best Supportive Care (BSC) n=136 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.	Best Supportive Care (BSC) n=66 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	Total n=202 Participants Total of all reporting groups
Age, Continuous	67.1 years STANDARD_DEVIATION 9.02 • n=5 Participants	66.8 years STANDARD_DEVIATION 8.06 • n=7 Participants	67.0 years STANDARD_DEVIATION 8.70 • n=5 Participants
Age, Customized <65 years	48 Participants n=5 Participants	27 Participants n=7 Participants	75 Participants n=5 Participants
Age, Customized >=65 years	88 Participants n=5 Participants	39 Participants n=7 Participants	127 Participants n=5 Participants
Age, Customized <70 years	79 Participants n=5 Participants	41 Participants n=7 Participants	120 Participants n=5 Participants
Age, Customized >=70 years	57 Participants n=5 Participants	25 Participants n=7 Participants	82 Participants n=5 Participants
Age, Customized <75 years	110 Participants n=5 Participants	55 Participants n=7 Participants	165 Participants n=5 Participants
Age, Customized >=75 years	26 Participants n=5 Participants	11 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	23 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants	43 Participants n=7 Participants	130 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	132 Participants n=5 Participants	61 Participants n=7 Participants	193 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	9 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized White	125 Participants n=5 Participants	62 Participants n=7 Participants	187 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0=fully active, no restriction	41 Participants n=5 Participants	19 Participants n=7 Participants	60 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1=fully ambulatory; restricted strenuous activity	95 Participants n=5 Participants	47 Participants n=7 Participants	142 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) >=2=ambulatory/self care; no work or worse	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Overall Tumor Response at End of Induction Complete response	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Overall Tumor Response at End of Induction Partial response	92 Participants n=5 Participants	42 Participants n=7 Participants	134 Participants n=5 Participants
Overall Tumor Response at End of Induction Stable disease	41 Participants n=5 Participants	21 Participants n=7 Participants	62 Participants n=5 Participants
Overall Tumor Response at End of Induction Progressive disease	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Overall Tumor Response at End of Induction Not evaluable	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Confirmed Histology Squamous cell carcinoma	136 Participants n=5 Participants	66 Participants n=7 Participants	202 Participants n=5 Participants
Confirmed Histology Squamous cell carcinoma not confirmed	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Disease Stage at Enrollment Stage IIIB	18 Participants n=5 Participants	8 Participants n=7 Participants	26 Participants n=5 Participants
Disease Stage at Enrollment Stage IV	118 Participants n=5 Participants	58 Participants n=7 Participants	176 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the date of randomization to the date of disease progression or death of any cause; up to data cut off date of 15 September 2017; up to 27.6 months

Population: Intent to treat (ITT) population of participants randomized to Maintenance. The ITT population in the Maintenance part included all randomized subjects regardless of whether the subject received any study drug or had any efficacy assessments collected.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + Best Supportive Care (BSC) n=136 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.	Best Supportive Care (BSC) n=66 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: Induction + Maintenance Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m\^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg\*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	Nab-Paclitaxel + BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the Nab-Paclitaxel + BSC treatment arm. BSC was administered during Maintenance.	BSC: Induction + Maintenance Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: TEAE Specific to Nab-Paclitaxel TEAE categories specific to nab-paclitaxel intervention, as determined by the investigator, for participants randomized to the BSC treatment arm. Nab-paclitaxel was administered during Induction.	BSC: TEAE Specific to Carboplatin TEAE categories specific to carboplatin intervention as determined by the investigator, for participants randomized to the BSC treatment arm. Carboplatin was administered during Induction.	BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the BSC treatment arm. BSC was administered during Maintenance.
Kaplan-Meier Estimate of Progression-Free Survival (PFS) From Randomization Into Maintenance	3.12 months Interval 2.73 to 4.6	2.60 months Interval 1.64 to 3.45	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the date of randomization to death from any cause; up to 01 August 2019; survival follow up was 55.89 months

Population: Intent to Treat population of participants randomized to maintenance.

Overall survival was defined as the duration in months between randomization and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off (01 August 2019 whichever was earlier. The last contact date was the date of the last record in the database, or if the subject was lost to follow-up, the last known date that the subject was alive.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + Best Supportive Care (BSC) n=136 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.	Best Supportive Care (BSC) n=66 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: Induction + Maintenance Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m\^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg\*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	Nab-Paclitaxel + BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the Nab-Paclitaxel + BSC treatment arm. BSC was administered during Maintenance.	BSC: Induction + Maintenance Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: TEAE Specific to Nab-Paclitaxel TEAE categories specific to nab-paclitaxel intervention, as determined by the investigator, for participants randomized to the BSC treatment arm. Nab-paclitaxel was administered during Induction.	BSC: TEAE Specific to Carboplatin TEAE categories specific to carboplatin intervention as determined by the investigator, for participants randomized to the BSC treatment arm. Carboplatin was administered during Induction.	BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the BSC treatment arm. BSC was administered during Maintenance.
Kaplan-Meier Estimate of Overall Survival (OS) From Randomization Into Maintenance	17.61 months Interval 13.86 to 21.09	12.16 months Interval 7.56 to 18.99	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 of treatment in the induction period and subsequent anticancer therapy, death or discontinuation up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study

Population: Intent to treat population of participants randomized to Maintenance

Overall response was defined as the percentage of participants with a confirmed assessment of complete response (CR) or partial response (PR) according to RECIST 1.1 criteria and confirmed in no less than 28 days. The 95% confidence interval (CI) was calculated using Clopper-Pearson method. RECIST 1.1 Definition: - Complete response-disappearance of all target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to \< 10 mm. - Partial response-at least a 30% decrease in the sum of diameters of target lesions from baseline.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + Best Supportive Care (BSC) n=136 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.	Best Supportive Care (BSC) n=66 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: Induction + Maintenance Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m\^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg\*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	Nab-Paclitaxel + BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the Nab-Paclitaxel + BSC treatment arm. BSC was administered during Maintenance.	BSC: Induction + Maintenance Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: TEAE Specific to Nab-Paclitaxel TEAE categories specific to nab-paclitaxel intervention, as determined by the investigator, for participants randomized to the BSC treatment arm. Nab-paclitaxel was administered during Induction.	BSC: TEAE Specific to Carboplatin TEAE categories specific to carboplatin intervention as determined by the investigator, for participants randomized to the BSC treatment arm. Carboplatin was administered during Induction.	BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the BSC treatment arm. BSC was administered during Maintenance.
Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) Over Entire Study	69.1 percentage of participants Interval 60.6 to 76.8	57.6 percentage of participants Interval 44.8 to 69.7	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Between Day 1 of the Induction Part through to the date of disease progression or death; up to 01 August 2019; the maximum treatment duration was 234.1 weeks for entire study

Population: Intent to treat population of participants randomized to Maintenance

PFS was defined as the time in months from Day 1 of treatment for the Induction part to the date of disease progression according to RECIST 1.1 criteria (documented by CT-scan, not including symptomatic deterioration) or death (any cause) on or prior to 01 August 2019, whichever occurred earlier. RECIST 1.1 Definition: - Progressive Disease (PD) - At least a 20% increase in the sum of diameters of target lesions from nadir; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of new lesions is also considered progression.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + Best Supportive Care (BSC) n=136 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.	Best Supportive Care (BSC) n=66 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: Induction + Maintenance Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m\^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg\*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	Nab-Paclitaxel + BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the Nab-Paclitaxel + BSC treatment arm. BSC was administered during Maintenance.	BSC: Induction + Maintenance Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: TEAE Specific to Nab-Paclitaxel TEAE categories specific to nab-paclitaxel intervention, as determined by the investigator, for participants randomized to the BSC treatment arm. Nab-paclitaxel was administered during Induction.	BSC: TEAE Specific to Carboplatin TEAE categories specific to carboplatin intervention as determined by the investigator, for participants randomized to the BSC treatment arm. Carboplatin was administered during Induction.	BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the BSC treatment arm. BSC was administered during Maintenance.
Kaplan-Meier Estimate of Progression-Free Survival (PFS) Over Entire Study	6.47 months Interval 5.65 to 7.79	5.55 months Interval 4.96 to 6.67	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Between Day 1 of treatment in the Induction Part to death from any cause; up to 01 August 2019; survival follow up was 55.89 months

Population: ITT population of participants randomized to Maintenance.

Overall survival was defined as the time in months from Day 1 of treatment for the Induction part to death from any cause. Subjects who were alive at the time of analysis had their OS censored at the date or last contact of 01 August 2019, whichever was earlier. The last contact date was the date of the last record in the database, or if the subject was lost to follow-up, the last known date that the subject was alive.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + Best Supportive Care (BSC) n=136 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.	Best Supportive Care (BSC) n=66 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: Induction + Maintenance Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m\^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg\*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	Nab-Paclitaxel + BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the Nab-Paclitaxel + BSC treatment arm. BSC was administered during Maintenance.	BSC: Induction + Maintenance Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: TEAE Specific to Nab-Paclitaxel TEAE categories specific to nab-paclitaxel intervention, as determined by the investigator, for participants randomized to the BSC treatment arm. Nab-paclitaxel was administered during Induction.	BSC: TEAE Specific to Carboplatin TEAE categories specific to carboplatin intervention as determined by the investigator, for participants randomized to the BSC treatment arm. Carboplatin was administered during Induction.	BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the BSC treatment arm. BSC was administered during Maintenance.
Kaplan-Meier Estimate of Overall Survival (OS) Over Entire Study	20.57 months Interval 17.05 to 24.05	15.05 months Interval 10.81 to 22.14	—	—	—	—	—	—

SECONDARY outcome

Timeframe: For the induction period the maximum treatment was 19 weeks for the maintenance period the maximum treatment was 150 weeks.

Population: Intent to treat population of participants randomized to the maintenance period.

Overall response in the maintenance period was defined as the percentage of participants who showed an improvement in best overall response from stable disease (SD) or partial response (PR) during Induction to a Complete Response (CR) or PR during Maintenance according to RECIST 1.1 criteria and confirmed in no less than 28 days. Evaluation takes as reference the lesion measurement or status at the last tumor assessment before randomization to Maintenance. The 95% CI was calculated using Clopper-Pearson method. RECIST 1.1 Definition: - Complete response-disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. - Partial response-at least a 30% decrease in the sum of diameters of target lesions from baseline. - Stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + Best Supportive Care (BSC) n=136 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.	Best Supportive Care (BSC) n=66 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: Induction + Maintenance Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m\^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg\*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	Nab-Paclitaxel + BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the Nab-Paclitaxel + BSC treatment arm. BSC was administered during Maintenance.	BSC: Induction + Maintenance Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: TEAE Specific to Nab-Paclitaxel TEAE categories specific to nab-paclitaxel intervention, as determined by the investigator, for participants randomized to the BSC treatment arm. Nab-paclitaxel was administered during Induction.	BSC: TEAE Specific to Carboplatin TEAE categories specific to carboplatin intervention as determined by the investigator, for participants randomized to the BSC treatment arm. Carboplatin was administered during Induction.	BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the BSC treatment arm. BSC was administered during Maintenance.
Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) In Maintenance Beyond the Response in Induction	9.6 percentage of participants Interval 5.2 to 15.8	3.0 percentage of participants Interval 0.4 to 10.5	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Induction is from Day 1 to a maximum treatment time of 19 weeks; entire study from Day 1 induction through maintenance up to PD; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study

Population: Induction includes the ITT population of participants treated during Induction. Entire Study includes the entire experience of the ITT population of participants randomized to maintenance.

Disease control rate was defined as the percentage of participants who had radiologic CR, PR or SD for \>= 6 weeks according to RECIST 1.1 criteria as determined by the investigator. Only participants with a confirmed CR/PR are included in this summary. Two timeframes are offered: - Time to confirmed response within the Induction timeframe. - Time to Confirmed Response Over the Entire Study, i.e. the time from Day 1 of treatment in Induction to the first occurrence of confirmed CR/PR any time during the study. RECIST 1.1 Definition: - CR- disappearance of all target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to \< 10 mm. - PR- at least a 30% decrease in the sum of diameters of target lesions from baseline; - SD- neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for PD. The 95% CI was calculated using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + Best Supportive Care (BSC) n=420 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.	Best Supportive Care (BSC) n=136 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: Induction + Maintenance n=66 Participants Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m\^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg\*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	Nab-Paclitaxel + BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the Nab-Paclitaxel + BSC treatment arm. BSC was administered during Maintenance.	BSC: Induction + Maintenance Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: TEAE Specific to Nab-Paclitaxel TEAE categories specific to nab-paclitaxel intervention, as determined by the investigator, for participants randomized to the BSC treatment arm. Nab-paclitaxel was administered during Induction.	BSC: TEAE Specific to Carboplatin TEAE categories specific to carboplatin intervention as determined by the investigator, for participants randomized to the BSC treatment arm. Carboplatin was administered during Induction.	BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the BSC treatment arm. BSC was administered during Maintenance.
Percentage of Participants Who Achieved Disease Control (Disease Control Rate) by Investigator Assessment During Induction and Over the Entire Study	47.9 percentage of participants Interval 43.0 to 52.8	99.3 percentage of participants Interval 96.0 to 100.0	100.0 percentage of participants Interval 94.6 to 100.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Induction is from Day 1 to a maximum treatment time of 19 weeks; entire study from Day 1 Induction through Maintenance up to PD; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study

Population: Includes the ITT population of participants who had a response. Induction includes the ITT population of participants treated during Induction who had a response. Induction+Maintenance includes the ITT population of participants randomized to Maintenance who had a response.

Time to confirmed complete or partial response (CR/PR) is defined as the time from day 1 of treatment in Induction to the first occurrence of confirmed CR/PR. Two timeframes are offered: - Time to confirmed response within the Induction timeframe. - Time to Confirmed Response Over the Entire Study, i.e. the time from Day 1 of treatment in Induction to the first occurrence of confirmed CR/PR any time during the study. Only participants with a confirmed CR or PR are included in this summary.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + Best Supportive Care (BSC) n=126 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.	Best Supportive Care (BSC) n=94 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: Induction + Maintenance n=38 Participants Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m\^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg\*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	Nab-Paclitaxel + BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the Nab-Paclitaxel + BSC treatment arm. BSC was administered during Maintenance.	BSC: Induction + Maintenance Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: TEAE Specific to Nab-Paclitaxel TEAE categories specific to nab-paclitaxel intervention, as determined by the investigator, for participants randomized to the BSC treatment arm. Nab-paclitaxel was administered during Induction.	BSC: TEAE Specific to Carboplatin TEAE categories specific to carboplatin intervention as determined by the investigator, for participants randomized to the BSC treatment arm. Carboplatin was administered during Induction.	BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the BSC treatment arm. BSC was administered during Maintenance.
Time to Confirmed Response During Induction and Over the Entire Study	1.446 months Interval 1.15 to 4.6	1.478 months Interval 1.15 to 8.51	1.413 months Interval 1.18 to 4.21	—	—	—	—	—

SECONDARY outcome

Timeframe: Between Day 1 of the Induction Period through to the date of disease progression or death; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study.

Population: The ITT population of participants randomized to the maintenance period and had a confirmed partial or complete response.

Duration of overall response was measured from the time criteria were first met for CR/PR until the first date the recurrent or progressive disease (PD) was radiologically documented. Participants who did not have PD after the response were censored on the date of last tumor assessment. If a participant died before PD, the participant was censored on the date of death.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + Best Supportive Care (BSC) n=94 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.	Best Supportive Care (BSC) n=38 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: Induction + Maintenance Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m\^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg\*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	Nab-Paclitaxel + BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the Nab-Paclitaxel + BSC treatment arm. BSC was administered during Maintenance.	BSC: Induction + Maintenance Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: TEAE Specific to Nab-Paclitaxel TEAE categories specific to nab-paclitaxel intervention, as determined by the investigator, for participants randomized to the BSC treatment arm. Nab-paclitaxel was administered during Induction.	BSC: TEAE Specific to Carboplatin TEAE categories specific to carboplatin intervention as determined by the investigator, for participants randomized to the BSC treatment arm. Carboplatin was administered during Induction.	BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the BSC treatment arm. BSC was administered during Maintenance.
Kaplan-Meier Estimate for Duration of Response Over the Entire Study	5.95 months Interval 4.6 to 7.06	4.60 months Interval 3.68 to 5.49	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Induction up to Week 23 (maximum treatment in Induction plus 4 weeks if not continuing into Maintenance)

Population: Safety population of participants treated during induction period.

TEAE in the Induction part is defined as any adverse event (AE) with an onset on or after Day 1 of treatment for the Induction part, and on or before the day of randomization for subjects who entered into the Maintenance part, or, for subjects who did not enter into the Maintenance part, before the treatment discontinuation date plus 28 days or any serious AE which occurred thereafter but was determined to be related to any study drug by the investigator. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild, Grade 2 = Moderate Grade, 3 = Severe Grade, 4 = Life threatening, Grade 5 = Death. Relation to study drug was determined by the investigator.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + Best Supportive Care (BSC) n=420 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.	Best Supportive Care (BSC) n=420 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: Induction + Maintenance n=420 Participants Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m\^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg\*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	Nab-Paclitaxel + BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the Nab-Paclitaxel + BSC treatment arm. BSC was administered during Maintenance.	BSC: Induction + Maintenance Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: TEAE Specific to Nab-Paclitaxel TEAE categories specific to nab-paclitaxel intervention, as determined by the investigator, for participants randomized to the BSC treatment arm. Nab-paclitaxel was administered during Induction.	BSC: TEAE Specific to Carboplatin TEAE categories specific to carboplatin intervention as determined by the investigator, for participants randomized to the BSC treatment arm. Carboplatin was administered during Induction.	BSC: TEAE Specific to BSC TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the BSC treatment arm. BSC was administered during Maintenance.
Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period Severity Grade 3/4 TEAE	337 Participants	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	—	—	—	—	—
Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period TEAE	419 Participants	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	—	—	—	—	—
Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period Serious TEAE	177 Participants	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	—	—	—	—	—
Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period Severity Grade 3 or higher TEAE	340 Participants	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	—	—	—	—	—
Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period Trt-related serious TEAE	82 Participants	80 Participants	73 Participants	—	—	—	—	—
Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period TEAE-study drug dose reduced or interrupted	341 Participants	340 Participants	291 Participants	—	—	—	—	—
Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period TEAE-study drug withdrawn	55 Participants	55 Participants	53 Participants	—	—	—	—	—
Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period Trt-related TEAE-study drug withdrawn	35 Participants	34 Participants	29 Participants	—	—	—	—	—
Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period TEAE-outcome of death	32 Participants	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	—	—	—	—	—
Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period Trt-related TEAE-outcome of death	7 Participants	7 Participants	6 Participants	—	—	—	—	—
Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period Treatment-related (trt-related) TEAE	408 Participants	407 Participants	394 Participants	—	—	—	—	—
Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period Trt-related TEAE-dose reduced or interrupted	301 Participants	292 Participants	236 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 up to 01 August 2019; (maximum treatment length plus 28 days); the maximum treatment duration was 234.1 weeks for entire study

Population: Safety population of participants randomized into maintenance, inclusive of both the induction and maintenance periods.

TEAE over entire study is defined as any adverse event (AE) with an onset on or after Day 1 of treatment for the Induction part, and before the treatment discontinuation date plus 28 days, or any serious AE which occurred thereafter but was determined to be related to any study drug by the investigator. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life threatening, Grade 5 = Death. Relation to study drug was determined by the investigator.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + Best Supportive Care (BSC) n=130 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression.	Best Supportive Care (BSC) n=130 Participants Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: Induction + Maintenance n=130 Participants Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m\^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg\*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	Nab-Paclitaxel + BSC: TEAE Specific to BSC n=130 Participants TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the Nab-Paclitaxel + BSC treatment arm. BSC was administered during Maintenance.	BSC: Induction + Maintenance n=62 Participants Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression.	BSC: TEAE Specific to Nab-Paclitaxel n=62 Participants TEAE categories specific to nab-paclitaxel intervention, as determined by the investigator, for participants randomized to the BSC treatment arm. Nab-paclitaxel was administered during Induction.	BSC: TEAE Specific to Carboplatin n=62 Participants TEAE categories specific to carboplatin intervention as determined by the investigator, for participants randomized to the BSC treatment arm. Carboplatin was administered during Induction.	BSC: TEAE Specific to BSC n=62 Participants TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the BSC treatment arm. BSC was administered during Maintenance.
Participants With Treatment-Emergent Adverse Events (TEAEs) Over the Entire Study TEAE	130 Participants	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	62 Participants	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention
Participants With Treatment-Emergent Adverse Events (TEAEs) Over the Entire Study Serious TEAE	54 Participants	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	21 Participants	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention
Participants With Treatment-Emergent Adverse Events (TEAEs) Over the Entire Study Severity Grade 3/4 TEAE	108 Participants	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	48 Participants	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention
Participants With Treatment-Emergent Adverse Events (TEAEs) Over the Entire Study Severity Grade 3 or higher TEAE	109 Participants	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	48 Participants	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention
Participants With Treatment-Emergent Adverse Events (TEAEs) Over the Entire Study Treatment-related (trt-related) TEAE	129 Participants	129 Participants	123 Participants	18 Participants	61 Participants	61 Participants	58 Participants	1 Participants
Participants With Treatment-Emergent Adverse Events (TEAEs) Over the Entire Study Trt-related serious TEAE	22 Participants	22 Participants	16 Participants	1 Participants	8 Participants	8 Participants	7 Participants	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAEs) Over the Entire Study TEAE-study drug dose reduced or interrupted	115 Participants	113 Participants	95 Participants	17 Participants	52 Participants	52 Participants	45 Participants	1 Participants
Participants With Treatment-Emergent Adverse Events (TEAEs) Over the Entire Study Trt-related TEAE-dose reduced or interrupted	107 Participants	104 Participants	85 Participants	0 Participants	45 Participants	45 Participants	37 Participants	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAEs) Over the Entire Study TEAE-study drug withdrawn	22 Participants	22 Participants	1 Participants	20 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAEs) Over the Entire Study Trt-related TEAE- study drug withdrawn	18 Participants	18 Participants	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAEs) Over the Entire Study TEAE-outcome of death	4 Participants	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	2 Participants	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention	NA Participants category not specific to study intervention
Participants With Treatment-Emergent Adverse Events (TEAEs) Over the Entire Study Trt-related TEAE-outcome of death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

All Participants - Induction

Serious events: 177 serious events

Other events: 417 other events

Deaths: 80 deaths

Nab-Paclitaxel + Best Supportive Care (Maintenance)

Serious events: 32 serious events

Other events: 122 other events

Deaths: 82 deaths

Best Supportive Care (Maintenance)

Serious events: 13 serious events

Other events: 45 other events

Deaths: 48 deaths

Serious adverse events

Other adverse events

Additional Information

Anne McClain, Senior Manager

Celgene Corporation

Phone: 888-260-1599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Results from a center cannot be submitted for publication before results of multicenter study are published unless it is \> 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.
Publication restrictions are in place

Restriction type: OTHER