A Phase 3 interventional study of Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody and Carboplatin in Squamous Non-Small Cell Lung Cancer, sponsored by Hoffmann-La Roche. Completed at 242 sites in 26 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-21.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 1,021 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The induction phase of the study will consist of four or six cycles; atezolizumab, paclitaxel, and carboplatin will be administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration is as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experience no further clinical benefit at any time during the induction phase will discontinue all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants will begin maintenance therapy with atezolizumab. Atezolizumab will be continued as long as there is a clinical benefit to the participant.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody · Drug: Carboplatin · Drug: Paclitaxel
The induction phase of the study will consist of four or six cycles; atezolizumab and carboplatin will be administered on Day 1 of each 21-day cycle. Nab-Paclitaxel will be administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration is as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experience no further clinical benefit at any time during the induction phase will discontinue all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants will begin maintenance therapy with atezolizumab. Atezolizumab will be continued as long as there is a clinical benefit to the participant.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody · Drug: Carboplatin · Drug: Nab-Paclitaxel
The induction phase of the study will consist of four or six cycles; carboplatin will be administered on Day 1 of each 21-day cycle, nab-paclitaxel will be administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration is as follows: nab-paclitaxel, then carboplatin. Participants who experience disease progression at any time during the induction phase will discontinue all study treatment. In the maintenance phase, participants will receive best supportive care.
Drug: Carboplatin · Drug: Nab-Paclitaxel
Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.
Also known as: Tecentriq
Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.
Nab-paclitaxel 100 milligrams per meter squared (mg/m\^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles.
Paclitaxel 200 mg/m\^2 IV on Day 1 of each 21-day cycle for 4 or 6 cycles. Participants of Asian race/ethnicity will be administered paclitaxel 175 mg/m\^2 IV.
Progression Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population
PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the ITT population.
Time frame: Up to approximately 30 months after first participant enrolled
Overall Survival (OS) in the ITT Population
OS is defined as the time between the date of randomization and date of death from any cause in the ITT population.
Time frame: Up to approximately 39 months after first participant enrolled
OS in the in the Teff Population
OS is defined as the time between the date of randomization and date of death from any cause in the in the Teff Population.
Time frame: Up to approximately 39 months after first participant enrolled
PFS as Determined by the Investigator Using RECIST v1.1 in the Teff Population
PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the Teff Population.
Time frame: Up to approximately 30 months after first participant enrolled
PFS as Determined by the Investigator Using RECIST v1.1 in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population
PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population.
Time frame: Up to approximately 30 months after first participant enrolled
PFS as Determined by the Investigator Using RECIST v1.1 in the TC1/2/3 or IC1/2/3 Population
PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the TC1/2/3 or IC1/2/3 Population.
Time frame: Up to approximately 30 months after first participant enrolled
OS in the TC2/3 or IC2/3 Population
OS is defined as the time between the date of randomization and date of death from any cause, in the TC2/3 or IC2/3 Population.
Time frame: Up to approximately 39 months after first participant enrolled
OS in the TC1/2/3 or IC1/2/3 Population
OS is defined as the time between the date of randomization and date of death from any cause in the TC1/2/3 or IC1/2/3 Population.
Time frame: Up to approximately 39 months after first participant enrolled
Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population
Proportion of participants with an objective response (CR or PR) in the ITT population.
Time frame: Up to approximately 30 months after first participant enrolled
Duration of Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population
Duration of response is defined as the time from the first documented objective response to documented PD or death from any cause, whichever occurred first, in the ITT Population.
Time frame: Up to approximately 30 months after first participant enrolled
Event Free Rate at 1 and 2 Years in the ITT Population
Event free rate at 1 and 2 years is defined as the proportion of participants alive at 1 and 2 years after randomization estimated using Kaplan-Meier (KM) methodology for the ITT population.
Time frame: 1 and 2 years
Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population
TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population. The EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC scales and single-item measures will be linearly transformed so that each score has a range of 0-100. A high score for a functional scale represents a high or healthy level of functioning, and a high score for the global health status and HRQoL represents a high HRQoL; however, a high score for a symptom scale or item represents a high level of symptomatology or problems.
Time frame: Up to approximately 30 months after first participant enrolled
TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-LC13 Symptom Subscales in the ITT Population
TTD was documented for a 3-symptom composite endpoint using the following EORTC QLQ-LC13 symptom scores: cough, chest pain, and dyspnea multi--item scale. In this instance, symptom deterioration will be determined as a \>= 10-point increase above baseline in any of the listed symptom scores, whichever occurs first (cough, chest pain, and dyspnea multi-item scale). Confirmed clinically meaningful symptom deterioration will need to be held for the original symptom; a \>= 10-point increase above baseline in a symptom score must be held for at least two consecutive assessments or an initial\>=10-point increase above baseline followed by death within 3 weeks from the last assessment. A \>= 10-point change in the EORTC scale score is perceived by patients as clinically significant.
Time frame: Up to approximately 30 months after the first participant enrolled
Change From Baseline in Patient-reported Lung Cancer Symptoms Score Using the SILC Scale Symptom Severity Score in the ITT Population
Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms \& are scored at individual symptom level, thus have a dyspnea score, chest pain score, \& cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 \& maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 \& 2, 'Cough' score is mean of question 3 \& 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea \& cough symptom scores is considered to be clinically significant; whereas a score change of ≥0.5 points for chest pain score is considered to be clinically significant. (Note: PD=progression of disease)
Time frame: Baseline up to approximately 30 months after first participant enrolled
PFS as Determined by the Investigator Using RECIST v1.1 in the ITT Population (Arm A and Arm B)
PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the ITT Population Arm A and Arm B.
Time frame: Up to approximately 30 months after first participant enrolled
OS in the ITT Population (Arm A and Arm B)
OS is defined as the time between the date of randomization and date of death from any cause in the ITT Population, Arm A and Arm B.
Time frame: Up to approximately 39 months after first participant enrolled
Percentage of Participants With Adverse Events
Percentage of participants with at least one adverse event.
Time frame: Up to approximately 68 months after first participant enrolled
Percentage of Participants With Anti-therapeutic Antibody (ATA) Response to Atezolizumab
Percentage of participants with Anti-therapeutic Antibody (ATA) response to atezolizumab.
Time frame: Up to approximately 30 months after first participant enrolled
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Maximum observed serum atezolizumab concentration (Cmax). The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.
Time frame: Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length = 21 days)
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Minimum observed serum atezolizumab concentration (Cmin). The predose samples will be collected on the same day of treatment administration.
Time frame: Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle thereafter (up to 30 months), at treatment discontinuation (up to 30 months), and at 120 days after the last dose of atezolizumab (up to approximately 30 months, each cycle is 21 days)
Plasma Concentrations for Paclitaxel
Plasma concentrations for paclitaxel.
Time frame: Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 180 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days)
Plasma Concentrations for Nab-Paclitaxel
Plasma concentrations for nab-paclitaxel.
Time frame: Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days)
Plasma Concentrations for Carboplatin
Plasma concentrations for carboplatin.
Time frame: Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 15 to 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days)
'Study Terminated By Sponsor' Reason for Not Completed is a data entry error; reason for not completed is unknown. The study was Completed and not Terminated.
| Milestone | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|---|
| Started | 340 | 343 | 338 |
| Completed | 0 | 0 | 0 |
| Not completed | 340 | 343 | 338 |
| Withdrew: Death | 252 | 245 | 243 |
| Withdrew: Lost to follow-up | 1 | 2 | 2 |
| Withdrew: Physician decision | 0 | 5 | 3 |
| Withdrew: Protocol violation | 1 | 0 | 1 |
| Withdrew: Withdrawal by subject | 25 | 12 | 20 |
| Withdrew: Brain metastasis | 1 | 0 | 0 |
| Withdrew: Randomized in error | 0 | 0 | 1 |
| Withdrew: Patient unable to receive carboplatin | 0 | 0 | 1 |
| Withdrew: Hypercalcemia prior to c1d1 | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 0 | 2 |
| Withdrew: Study terminated by sponsor | 0 | 1 | 1 |
| Withdrew: Moved to roll-over study | 0 | 15 | 13 |
| Withdrew: Sponsor request | 60 | 57 | 45 |
| Withdrew: Moved into ptap study | 0 | 2 | 3 |
| Withdrew: Moved to commercial atezolizumab use | 0 | 2 | 1 |
| Withdrew: Investigational product availability in commercial stock | 0 | 1 | 0 |
| Withdrew: Participant enrolled in extended protocol | 0 | 1 | 0 |
| Withdrew: Discontinuation matched treatment discontinuation | 0 | 0 | 1 |
PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the ITT population.
| Months | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|---|
| Progression Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population | 5.6 (5.5 to 5.7) | 6.5 (5.7 to 7.1) | 5.6 (5.5 to 6.9) |
OS is defined as the time between the date of randomization and date of death from any cause in the ITT population.
| Months | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|---|
| Overall Survival (OS) in the ITT Population | 13.5 (12.2 to 15.1) | 14.2 (12.3 to 16.8) | 12.6 (11.6 to 14.7) |
OS is defined as the time between the date of randomization and date of death from any cause in the in the Teff Population.
| Month | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|---|
| Teff >=-1.91 | 16.4 (12.2 to 19.7) | 17.4 (12.3 to 23.8) | 15.2 (13.4 to 22.8) |
| Teff<-1.91 | 12.4 (11.2 to 14.3) | 13.0 (11.4 to 14.8) | 10.5 (9.1 to 12.6) |
PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the Teff Population.
| Months | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|---|
| Teff >=-1.91 | 5.6 (5.1 to 5.7) | 7.0 (5.5 to 8.5) | 7.0 (5.6 to 9.7) |
| Teff<-1.91 | 5.7 (5.5 to 6.6) | 6.2 (5.6 to 7.0) | 5.5 (4.5 to 5.6) |
PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population.
| Months | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|---|
| PFS as Determined by the Investigator Using RECIST v1.1 in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population | 5.6 (5.1 to 5.7) | 8.4 (6.8 to 10.4) | 7.0 (5.6 to 8.3) |
PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the TC1/2/3 or IC1/2/3 Population.
| Months | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|---|
| PFS as Determined by the Investigator Using RECIST v1.1 in the TC1/2/3 or IC1/2/3 Population | 5.6 (5.3 to 5.7) | 7.1 (5.8 to 8.3) | 7.0 (5.6 to 8.3) |
OS is defined as the time between the date of randomization and date of death from any cause, in the TC2/3 or IC2/3 Population.
| Months | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|---|
| OS in the TC2/3 or IC2/3 Population | 14.5 (12.1 to 17.2) | 20.4 (13.8 to 24.1) | 14.8 (11.1 to 23.7) |
OS is defined as the time between the date of randomization and date of death from any cause in the TC1/2/3 or IC1/2/3 Population.
| Months | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|---|
| OS in the TC1/2/3 or IC1/2/3 Population | 15.0 (12.4 to 17.2) | 14.8 (12.1 to 19.6) | 14.9 (12.5 to 18.2) |
Proportion of participants with an objective response (CR or PR) in the ITT population.
| Percentage of participants | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|---|
| Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population | 41.0 | 49.7 | 49.3 |
Duration of response is defined as the time from the first documented objective response to documented PD or death from any cause, whichever occurred first, in the ITT Population.
| Months | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|---|
| Duration of Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population | 5.2 (4.4 to 5.6) | 7.2 (6.8 to 9.5) | 7.0 (5.7 to 8.3) |
Event free rate at 1 and 2 years is defined as the proportion of participants alive at 1 and 2 years after randomization estimated using Kaplan-Meier (KM) methodology for the ITT population.
| Percentage of participants | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|---|
| 1 Year | 56.28 | 56.34 | 52.30 |
| 2 Year | 26.58 | 32.51 | 27.79 |
TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population. The EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC scales and single-item measures will be linearly transformed so that each score has a range of 0-100. A high score for a functional scale represents a high or healthy level of functioning, and a high score for the global health status and HRQoL represents a high HRQoL; however, a high score for a symptom scale or item represents a high level of symptomatology or problems.
| Months | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|---|
| Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population | 3.2 (2.6 to 4.1) | 4.2 (3.2 to 5.6) | 3.0 (2.6 to 3.9) |
TTD was documented for a 3-symptom composite endpoint using the following EORTC QLQ-LC13 symptom scores: cough, chest pain, and dyspnea multi--item scale. In this instance, symptom deterioration will be determined as a \>= 10-point increase above baseline in any of the listed symptom scores, whichever occurs first (cough, chest pain, and dyspnea multi-item scale). Confirmed clinically meaningful symptom deterioration will need to be held for the original symptom; a \>= 10-point increase above baseline in a symptom score must be held for at least two consecutive assessments or an initial\>=10-point increase above baseline followed by death within 3 weeks from the last assessment. A \>= 10-point change in the EORTC scale score is perceived by patients as clinically significant.
| Months | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|---|
| TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-LC13 Symptom Subscales in the ITT Population | 2.6 (2.2 to 3.0) | 3.4 (2.7 to 5.1) | 2.8 (2.1 to 3.7) |
Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms \& are scored at individual symptom level, thus have a dyspnea score, chest pain score, \& cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 \& maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 \& 2, 'Cough' score is mean of question 3 \& 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea \& cough symptom scores is considered to be clinically significant; whereas a score change of ≥0.5 points for chest pain score is considered to be clinically significant. (Note: PD=progression of disease)
| Units on a scale | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|---|
| Chest Pain, Week 1 | 0.04 ± 0.93 | 0.14 ± 0.87 | 0.44 ± 1.03 |
| Chest Pain, Week 2 | -0.08 ± 0.89 | 0.09 ± 0.98 | 0.28 ± 1.00 |
| Chest Pain, Week 3 | -0.14 ± 0.95 | -0.03 ± 0.78 | -0.05 ± 1.00 |
| Chest Pain, Week 4 | -0.19 ± 0.98 | -0.05 ± 0.98 | 0.09 ± 1.12 |
| Chest Pain, Week 5 | -0.17 ± 1.10 | -0.08 ± 0.99 | -0.16 ± 1.09 |
| Chest Pain, Week 6 | -0.35 ± 1.08 | -0.13 ± 0.99 | -0.20 ± 1.02 |
| Chest Pain, Week 7 | -0.38 ± 1.12 | -0.18 ± 0.92 | -0.14 ± 1.16 |
| Chest Pain, Week 8 | -0.35 ± 1.12 | -0.17 ± 1.02 | -0.17 ± 1.09 |
| Chest Pain, Week 9 | -0.36 ± 1.00 | -0.19 ± 0.97 | -0.21 ± 1.10 |
| Chest Pain, Week 10 | -0.20 ± 1.09 | -0.16 ± 1.00 | -0.08 ± 1.19 |
| Chest Pain, Week 11 | -0.27 ± 1.08 | -0.24 ± 0.91 | -0.09 ± 1.16 |
| Chest Pain, Week 12 | -0.34 ± 1.05 | -0.21 ± 1.01 | -0.30 ± 1.05 |
| Chest Pain, Week 13 | -0.31 ± 1.24 | -0.22 ± 1.02 | -0.17 ± 1.10 |
| Chest Pain, Week 14 | -0.32 ± 1.18 | -0.24 ± 0.88 | -0.15 ± 1.13 |
| Chest Pain, Week 15 | -0.45 ± 1.19 | -0.28 ± 0.99 | -0.17 ± 1.00 |
| Chest Pain, Week 16 | -0.28 ± 1.10 | -0.14 ± 1.00 | -0.23 ± 1.10 |
| Chest Pain, Week 17 | -0.32 ± 1.11 | -0.17 ± 0.99 | -0.24 ± 1.10 |
| Chest Pain, Week 18 | -0.28 ± 1.08 | -0.13 ± 0.99 | -0.17 ± 1.09 |
| Chest Pain, Week 19 | -0.18 ± 1.09 | -0.10 ± 0.99 | -0.16 ± 1.07 |
| Chest Pain, Week 20 | -0.23 ± 1.07 | -0.15 ± 0.94 | -0.17 ± 1.13 |
| Chest Pain, Week 21 | -0.37 ± 1.02 | -0.07 ± 1.02 | -0.18 ± 1.14 |
| Chest Pain, Week 22 | -0.27 ± 1.18 | -0.08 ± 1.01 | -0.14 ± 1.16 |
| Chest Pain, Week 23 | -0.29 ± 1.16 | 0.04 ± 0.96 | -0.10 ± 1.07 |
| Chest Pain, Week 24 | -0.43 ± 1.15 | -0.15 ± 0.97 | -0.17 ± 1.14 |
| Chest Pain, Week 25 | -0.25 ± 1.24 | -0.17 ± 1.06 | -0.20 ± 1.10 |
| Chest Pain, Week 26 | -0.50 ± 1.20 | -0.06 ± 1.08 | -0.11 ± 1.09 |
| Chest Pain, Week 27 | -0.35 ± 1.29 | -0.17 ± 1.03 | 0.04 ± 1.14 |
| Chest Pain, Week 28 | -0.22 ± 1.27 | -0.12 ± 1.09 | -0.19 ± 1.24 |
| Chest Pain, Week 29 | -0.30 ± 1.23 | -0.11 ± 0.96 | -0.18 ± 1.11 |
| Chest Pain, Week 30 | -0.15 ± 1.36 | -0.21 ± 1.02 | -0.08 ± 1.09 |
| Chest Pain, Week 31 | -0.49 ± 1.25 | -0.16 ± 0.99 | -0.15 ± 1.08 |
| Chest Pain, Week 32 | -0.29 ± 1.16 | -0.15 ± 0.88 | -0.16 ± 1.01 |
| Chest Pain, Week 33 | -0.29 ± 1.35 | -0.20 ± 0.97 | -0.10 ± 1.09 |
| Chest Pain, Week 34 | -0.15 ± 1.42 | -0.04 ± 0.89 | 0.02 ± 1.16 |
| Chest Pain, Week 35 | -0.26 ± 1.31 | -0.14 ± 0.88 | -0.19 ± 1.09 |
| Chest Pain, Week 36 | -0.24 ± 1.34 | -0.06 ± 0.88 | -0.06 ± 1.12 |
| Chest Pain, Week 37 | -0.27 ± 1.37 | 0.05 ± 1.06 | -0.08 ± 1.08 |
| Chest Pain, Week 38 | -0.19 ± 1.30 | -0.09 ± 0.97 | -0.14 ± 1.13 |
| Chest Pain, Week 39 | -0.06 ± 1.53 | -0.18 ± 0.96 | -0.13 ± 1.13 |
| Chest Pain, Week 40 | 0.06 ± 1.31 | -0.11 ± 0.85 | -0.06 ± 1.01 |
| Chest Pain, Week 41 | 0.14 ± 1.21 | -0.14 ± 0.92 | -0.13 ± 1.05 |
| Chest Pain, Week 42 | -0.10 ± 1.50 | -0.05 ± 0.94 | -0.11 ± 1.02 |
| Chest Pain, Week 43 | 0.13 ± 1.59 | -0.08 ± 0.99 | 0.05 ± 1.13 |
| Chest Pain, Week 44 | -0.08 ± 1.52 | -0.25 ± 0.99 | -0.10 ± 1.07 |
| Chest Pain, Week 45 | 0.15 ± 1.70 | -0.21 ± 0.97 | -0.05 ± 1.20 |
| Chest Pain, Week 46 | 0.00 ± 1.39 | -0.16 ± 1.04 | -0.07 ± 1.33 |
| Chest Pain, Week 47 | 0.18 ± 1.29 | -0.16 ± 0.99 | 0.04 ± 1.29 |
| Chest Pain, Week 48 | -0.08 ± 1.53 | -0.17 ± 0.97 | 0.00 ± 1.32 |
| Chest Pain, Week 49 | -0.23 ± 1.59 | -0.24 ± 1.05 | -0.09 ± 1.31 |
| Chest Pain, Week 50 | 0.00 ± 1.73 | -0.17 ± 0.98 | -0.14 ± 1.36 |
| Chest Pain, Week 51 | 0.55 ± 1.39 | -0.16 ± 1.07 | -0.19 ± 1.24 |
| Chest Pain, Week 52 | 0.15 ± 1.30 | -0.09 ± 0.98 | 0.02 ± 1.30 |
| Chest Pain, Week 53 | 0.18 ± 1.27 | -0.12 ± 0.95 | -0.20 ± 1.22 |
| Chest Pain, Week 54 | 0.08 ± 1.17 | -0.18 ± 0.92 | -0.24 ± 1.34 |
| Chest Pain, Week 55 | 0.21 ± 1.37 | -0.11 ± 0.79 | -0.15 ± 1.19 |
| Chest Pain, Week 56 | 0.05 ± 1.39 | -0.22 ± 0.91 | -0.08 ± 1.36 |
| Chest Pain, Week 57 | 0.05 ± 1.46 | -0.22 ± 0.95 | -0.27 ± 1.22 |
| Chest Pain, Week 58 | 0.13 ± 1.25 | -0.22 ± 0.86 | -0.24 ± 1.12 |
| Chest Pain, Week 59 | 0.00 ± 1.32 | -0.20 ± 1.01 | -0.28 ± 1.17 |
| Chest Pain, Week 60 | 0.09 ± 1.59 | -0.27 ± 0.97 | -0.26 ± 1.22 |
| Chest Pain, Week 61 | 0.61 ± 1.29 | -0.23 ± 0.83 | -0.34 ± 1.23 |
| Chest Pain, Week 62 | 0.05 ± 1.34 | -0.03 ± 1.00 | -0.36 ± 0.96 |
| Chest Pain, Week 63 | -0.44 ± 1.21 | -0.12 ± 0.92 | -0.55 ± 1.13 |
| Chest Pain, Week 64 | 0.19 ± 1.49 | -0.13 ± 0.99 | -0.42 ± 1.33 |
| Chest Pain, Week 65 | 0.25 ± 1.37 | -0.13 ± 0.95 | -0.25 ± 1.21 |
| Chest Pain, Week 66 | 0.42 ± 1.53 | 0.00 ± 1.26 | -0.47 ± 1.18 |
| Chest Pain, Week 67 | -0.50 ± 1.27 | -0.08 ± 1.04 | -0.43 ± 1.27 |
| Chest Pain, Week 68 | 0.08 ± 1.77 | -0.09 ± 1.02 | -0.53 ± 1.23 |
| Chest Pain, Week 69 | 0.70 ± 1.60 | -0.15 ± 1.08 | -0.03 ± 1.14 |
| Chest Pain, Week 70 | 0.30 ± 1.79 | -0.06 ± 0.97 | -0.32 ± 1.08 |
| Chest Pain, Week 71 | 0.08 ± 1.72 | -0.13 ± 0.91 | -0.43 ± 1.22 |
| Chest Pain, Week 72 | 0.25 ± 1.70 | -0.20 ± 0.94 | -0.14 ± 1.00 |
| Chest Pain, Week 73 | 0.42 ± 1.53 | -0.02 ± 1.09 | -0.08 ± 1.27 |
| Chest Pain, Week 74 | 0.43 ± 1.62 | -0.10 ± 1.14 | -0.38 ± 1.21 |
| Chest Pain, Week 75 | 0.25 ± 1.70 | -0.17 ± 0.89 | -0.21 ± 1.18 |
| Chest Pain, Week 76 | 0.00 ± 1.76 | -0.02 ± 1.03 | -0.21 ± 1.25 |
| Chest Pain, Week 77 | 0.00 ± 1.76 | 0.00 ± 1.15 | -0.05 ± 1.21 |
| Chest Pain, Week 78 | 0.07 ± 1.62 | -0.11 ± 1.11 | 0.00 ± 1.02 |
| Chest Pain, Week 79 | 0.08 ± 1.72 | -0.13 ± 0.86 | 0.17 ± 0.94 |
| Chest Pain, Week 80 | 0.14 ± 1.65 | -0.35 ± 0.99 | 0.09 ± 1.14 |
| Chest Pain, Week 81 | 0.25 ± 1.70 | -0.25 ± 0.90 | 0.22 ± 0.97 |
| Chest Pain, Week 82 | 0.07 ± 1.62 | -0.31 ± 1.03 | 0.22 ± 1.12 |
| Chest Pain, Week 83 | 0.00 ± 1.77 | -0.32 ± 1.03 | -0.05 ± 1.01 |
| Chest Pain, Week 84 | 0.00 ± 1.84 | -0.33 ± 1.08 | 0.35 ± 1.00 |
| Chest Pain, Week 85 | 1.13 ± 1.31 | -0.35 ± 1.03 | 0.30 ± 1.14 |
| Chest Pain, Week 86 | 1.33 ± 1.53 | -0.37 ± 0.95 | 0.33 ± 1.37 |
| Chest Pain, Week 87 | 1.00 ± 1.73 | -0.25 ± 1.10 | 0.13 ± 0.99 |
| Chest Pain, Week 88 | 0.83 ± 1.44 | -0.20 ± 1.22 | 0.00 ± 1.00 |
| Chest Pain, Week 89 | 0.67 ± 2.08 | -0.14 ± 1.08 | -0.29 ± 1.25 |
| Chest Pain, Week 90 | 0.67 ± 2.08 | -0.04 ± 1.25 | 0.00 ± 1.29 |
| Chest Pain, Week 91 | 1.17 ± 1.61 | -0.42 ± 1.13 | 0.14 ± 1.07 |
| Chest Pain, Week 92 | 0.88 ± 1.44 | -0.15 ± 1.20 | 0.19 ± 1.25 |
| Chest Pain, Week 93 | 1.50 ± 2.12 | 0.00 ± 1.24 | -0.05 ± 1.01 |
| Chest Pain, Week 94 | 0.67 ± 2.08 | -0.23 ± 1.35 | 0.00 ± 1.20 |
| Chest Pain, Week 95 | 0.67 ± 2.08 | 0.14 ± 1.19 | 0.25 ± 1.00 |
| Chest Pain, Week 96 | 1.17 ± 1.61 | 0.09 ± 1.53 | 0.19 ± 0.92 |
| Chest Pain, Week 97 | 1.17 ± 1.61 | -0.18 ± 1.54 | -0.11 ± 1.17 |
| Chest Pain, Week 98 | 0.83 ± 2.02 | 0.05 ± 1.48 | 0.00 ± 1.00 |
| Chest Pain, Week 99 | 0.67 ± 2.08 | 0.00 ± 1.53 | 0.07 ± 1.02 |
| Chest Pain, Week 100 | 1.25 ± 1.77 | -0.15 ± 1.43 | 0.00 ± 1.20 |
| Chest Pain, Week 101 | 1.17 ± 1.61 | -0.10 ± 1.54 | 0.21 ± 0.99 |
| Chest Pain, Week 102 | 1.00 ± 1.32 | -0.25 ± 0.88 | 0.08 ± 1.11 |
| Chest Pain, Week 103 | -0.50 ± 0.71 | -0.56 ± 1.04 | 0.17 ± 1.17 |
| Chest Pain, Week 104 | 0.25 ± 0.35 | -0.56 ± 1.05 | 0.00 ± 1.41 |
| Chest Pain, Week 105 | 0.50 ± 0.00 | -0.50 ± 0.84 | 0.00 ± 1.10 |
| Chest Pain, Week 106 | 0.00 ± 0.00 | -0.72 ± 1.06 | -0.40 ± 1.14 |
| Chest Pain, Week 107 | 0.25 ± 0.35 | -0.57 ± 1.17 | -0.50 ± 0.58 |
| Chest Pain, Week 108 | 0.25 ± 0.35 | -0.30 ± 1.25 | -0.38 ± 0.75 |
| Chest Pain, Week 109 | -0.50 ± 0.71 | -0.90 ± 1.24 | 0.25 ± 1.77 |
| Chest Pain, Week 110 | 0.00 ± 0.71 | -0.50 ± 1.32 | -0.38 ± 1.11 |
| Chest Pain, Week 111 | 0.25 ± 0.35 | -0.25 ± 1.26 | -0.38 ± 0.48 |
| Chest Pain, Week 112 | 0.50 ± 0.00 | -0.67 ± 1.15 | -1.00 ± 0.00 |
| Chest Pain, Week 113 | 0.00 | -0.50 ± 1.00 | -0.67 ± 0.58 |
| Chest Pain, Week 114 | -0.25 ± 1.06 | -0.50 ± 1.32 | -1.00 ± 0.00 |
| Chest Pain, Week 115 | -0.25 ± 1.06 | -0.50 ± 1.00 | -0.67 ± 0.58 |
| Chest Pain, Week 116 | -0.50 ± 0.71 | -0.67 ± 1.15 | -0.67 ± 0.58 |
| Chest Pain, Week 117 | -0.25 ± 1.06 | -1.00 ± 1.41 | -1.00 ± 0.00 |
| Chest Pain, Week 118 | 0.00 | 0.00 | -1.00 ± 0.00 |
| Chest Pain, Week 119 | — | 0.00 | -1.00 ± 0.00 |
| Chest Pain, Week 120 | — | 0.00 | -1.00 ± 0.00 |
| Chest Pain, Week 121 | — | 0.00 | -1.00 ± 0.00 |
| Chest Pain, Week 122 | — | 0.00 | -1.00 ± 0.00 |
| Chest Pain, Week 123 | — | 0.00 | -1.00 |
| Chest Pain, Week 124 | — | 0.00 | -0.50 |
| Chest Pain, Week 125 | — | — | -0.50 |
| Chest Pain, Week 126 | — | — | -0.50 |
| Chest Pain, Week 127 | — | — | -1.00 |
| Chest Pain, Time of First Pd | -0.19 ± 1.13 | 0.10 ± 1.12 | -0.11 ± 1.21 |
| Chest Pain, Time of Last Tx Dose | -0.18 ± 1.06 | 0.01 ± 1.09 | 0.05 ± 1.14 |
| Chest Pain, Survival Follow-Up Month 1 | 0.03 ± 1.30 | — | — |
| Chest Pain, Survival Follow-Up Month 2 | -0.10 ± 1.23 | — | — |
| Chest Pain, Survival Follow-Up Month 3 | -0.09 ± 1.13 | — | — |
| Chest Pain, Survival Follow-Up Month 4 | -0.13 ± 1.15 | — | — |
| Chest Pain, Survival Follow-Up Month 5 | -0.02 ± 1.34 | — | — |
| Chest Pain, Survival Follow-Up Month 6 | -0.22 ± 0.99 | — | — |
| Chest Pain, Survival Follow-Up Month 7 | 0.33 ± 0.58 | — | — |
| Chest Pain, Survival Follow-Up Month 8 | -0.75 ± 1.06 | — | — |
| Cough, Week 1 | 0.01 ± 0.78 | 0.03 ± 0.82 | -0.02 ± 0.74 |
| Cough, Week 2 | -0.02 ± 0.91 | 0.00 ± 0.90 | 0.17 ± 0.87 |
| Cough, Week 3 | -0.09 ± 0.90 | -0.10 ± 1.03 | -0.08 ± 0.95 |
| Cough, Week 4 | -0.26 ± 0.92 | -0.16 ± 1.04 | -0.33 ± 1.07 |
| Cough, Week 5 | -0.18 ± 1.02 | -0.24 ± 1.08 | -0.19 ± 1.13 |
| Cough, Week 6 | -0.27 ± 1.05 | -0.22 ± 1.01 | -0.35 ± 1.11 |
| Cough, Week 7 | -0.27 ± 1.06 | -0.27 ± 1.07 | -0.47 ± 1.11 |
| Cough, Week 8 | -0.26 ± 1.11 | -0.26 ± 0.97 | -0.36 ± 1.09 |
| Cough, Week 9 | -0.32 ± 1.16 | -0.27 ± 1.01 | -0.34 ± 1.09 |
| Cough, Week 10 | -0.28 ± 1.02 | -0.28 ± 1.09 | -0.42 ± 1.08 |
| Cough, Week 11 | -0.31 ± 0.98 | -0.27 ± 1.14 | -0.50 ± 1.06 |
| Cough, Week 12 | -0.30 ± 1.08 | -0.25 ± 1.13 | -0.46 ± 1.06 |
| Cough, Week 13 | -0.23 ± 1.14 | -0.28 ± 1.17 | -0.46 ± 1.10 |
| Cough, Week 14 | -0.31 ± 1.09 | -0.29 ± 1.13 | -0.50 ± 1.16 |
| Cough, Week 15 | -0.39 ± 1.11 | -0.23 ± 1.03 | -0.47 ± 1.18 |
| Cough, Week 16 | -0.19 ± 1.19 | -0.18 ± 1.14 | -0.52 ± 1.25 |
| Cough, Week 17 | -0.18 ± 1.08 | -0.21 ± 1.06 | -0.48 ± 1.16 |
| Cough, Week 18 | -0.26 ± 1.09 | -0.34 ± 1.12 | -0.48 ± 1.05 |
| Cough, Week 19 | -0.29 ± 1.05 | -0.29 ± 1.12 | -0.37 ± 1.04 |
| Cough, Week 20 | -0.29 ± 1.09 | -0.24 ± 1.00 | -0.51 ± 1.15 |
| Cough, Week 21 | -0.36 ± 1.01 | -0.26 ± 1.06 | -0.46 ± 1.09 |
| Cough, Week 22 | -0.25 ± 1.13 | -0.27 ± 1.09 | -0.44 ± 1.11 |
| Cough, Week 23 | -0.26 ± 1.19 | -0.30 ± 1.07 | -0.45 ± 1.17 |
| Cough, Week 24 | -0.28 ± 1.14 | -0.33 ± 1.00 | -0.46 ± 1.11 |
| Cough, Week 25 | -0.28 ± 1.18 | -0.31 ± 1.09 | -0.52 ± 1.06 |
| Cough, Week 26 | -0.41 ± 1.08 | -0.32 ± 1.09 | -0.54 ± 1.24 |
| Cough, Week 27 | -0.27 ± 1.11 | -0.39 ± 1.10 | -0.31 ± 1.20 |
| Cough, Week 28 | -0.34 ± 1.10 | -0.36 ± 1.07 | -0.52 ± 1.21 |
| Cough, Week 29 | -0.38 ± 1.15 | -0.33 ± 1.06 | -0.48 ± 1.13 |
| Cough, Week 30 | -0.29 ± 1.15 | -0.31 ± 1.02 | -0.54 ± 1.14 |
| Cough, Week 31 | -0.46 ± 1.14 | -0.34 ± 1.11 | -0.49 ± 1.10 |
| Cough, Week 32 | -0.17 ± 0.98 | -0.41 ± 1.02 | -0.53 ± 1.04 |
| Cough, Week 33 | -0.31 ± 1.11 | -0.35 ± 0.97 | -0.53 ± 1.13 |
| Cough, Week 34 | -0.03 ± 0.93 | -0.34 ± 0.84 | -0.41 ± 1.14 |
| Cough, Week 35 | -0.14 ± 1.01 | -0.38 ± 0.91 | -0.47 ± 1.05 |
| Cough, Week 36 | -0.05 ± 0.93 | -0.39 ± 0.96 | -0.43 ± 0.99 |
| Cough, Week 37 | -0.08 ± 1.11 | -0.22 ± 0.94 | -0.54 ± 1.12 |
| Cough, Week 38 | 0.02 ± 1.09 | -0.36 ± 0.97 | -0.45 ± 1.16 |
| Cough, Week 39 | 0.00 ± 1.05 | -0.46 ± 1.05 | -0.50 ± 1.06 |
| Cough, Week 40 | 0.10 ± 1.12 | -0.39 ± 1.04 | -0.47 ± 1.02 |
| Cough, Week 41 | 0.07 ± 1.21 | -0.43 ± 1.10 | -0.58 ± 1.06 |
| Cough, Week 42 | -0.04 ± 1.16 | -0.41 ± 1.05 | -0.68 ± 1.05 |
| Cough, Week 43 | -0.02 ± 0.87 | -0.38 ± 1.04 | -0.45 ± 0.99 |
| Cough, Week 44 | -0.05 ± 1.24 | -0.48 ± 1.21 | -0.56 ± 1.09 |
| Cough, Week 45 | 0.10 ± 1.24 | -0.32 ± 1.11 | -0.69 ± 1.00 |
| Cough, Week 46 | 0.03 ± 0.95 | -0.38 ± 1.11 | -0.67 ± 1.10 |
| Cough, Week 47 | 0.10 ± 1.15 | -0.38 ± 1.13 | -0.54 ± 0.97 |
| Cough, Week 48 | 0.00 ± 1.22 | -0.41 ± 1.09 | -0.55 ± 1.09 |
| Cough, Week 49 | -0.12 ± 1.04 | -0.44 ± 1.10 | -0.63 ± 1.06 |
| Cough, Week 50 | 0.23 ± 0.98 | -0.29 ± 1.16 | -0.72 ± 1.07 |
| Cough, Week 51 | 0.05 ± 0.88 | -0.22 ± 1.20 | -0.69 ± 1.11 |
| Cough, Week 52 | 0.12 ± 0.79 | -0.33 ± 1.19 | -0.64 ± 1.03 |
| Cough, Week 53 | 0.21 ± 0.78 | -0.28 ± 1.14 | -0.53 ± 1.19 |
| Cough, Week 54 | 0.08 ± 0.89 | -0.45 ± 1.06 | -0.63 ± 1.23 |
| Cough, Week 55 | 0.29 ± 1.05 | -0.38 ± 1.12 | -0.68 ± 1.17 |
| Cough, Week 56 | 0.14 ± 1.05 | -0.46 ± 1.13 | -0.51 ± 1.07 |
| Cough, Week 57 | 0.10 ± 0.81 | -0.36 ± 1.25 | -0.74 ± 1.10 |
| Cough, Week 58 | 0.06 ± 0.94 | -0.51 ± 1.14 | -0.67 ± 1.06 |
| Cough, Week 59 | 0.18 ± 0.81 | -0.45 ± 1.19 | -0.81 ± 1.12 |
| Cough, Week 60 | 0.14 ± 0.71 | -0.41 ± 1.26 | -0.69 ± 1.04 |
| Cough, Week 61 | 0.00 ± 0.97 | -0.38 ± 1.27 | -0.84 ± 1.08 |
| Cough, Week 62 | -0.05 ± 0.86 | -0.29 ± 1.29 | -0.78 ± 1.04 |
| Cough, Week 63 | 0.19 ± 0.70 | -0.30 ± 1.09 | -0.82 ± 0.99 |
| Cough, Week 64 | 0.13 ± 1.16 | -0.27 ± 1.21 | -0.81 ± 0.93 |
| Cough, Week 65 | 0.08 ± 0.97 | -0.28 ± 1.26 | -0.70 ± 1.15 |
| Cough, Week 66 | 0.08 ± 0.86 | -0.30 ± 1.22 | -0.82 ± 1.15 |
| Cough, Week 67 | -0.30 ± 0.67 | -0.44 ± 1.29 | -0.78 ± 1.09 |
| Cough, Week 68 | 0.00 ± 0.95 | -0.21 ± 1.36 | -0.66 ± 1.17 |
| Cough, Week 69 | 0.20 ± 0.91 | -0.26 ± 1.29 | -0.78 ± 1.14 |
| Cough, Week 70 | 0.20 ± 0.91 | -0.28 ± 1.13 | -0.92 ± 1.18 |
| Cough, Week 71 | -0.17 ± 1.21 | -0.15 ± 1.01 | -0.90 ± 1.21 |
| Cough, Week 72 | 0.00 ± 1.38 | -0.19 ± 1.10 | -0.72 ± 1.05 |
| Cough, Week 73 | 0.00 ± 1.38 | -0.22 ± 1.15 | -1.00 ± 1.38 |
| Cough, Week 74 | 0.07 ± 0.89 | -0.22 ± 0.97 | -1.04 ± 1.21 |
| Cough, Week 75 | 0.08 ± 1.24 | -0.17 ± 1.12 | -1.04 ± 1.29 |
| Cough, Week 76 | 0.00 ± 1.38 | 0.07 ± 1.16 | -1.18 ± 1.12 |
| Cough, Week 77 | 0.25 ± 1.29 | -0.18 ± 1.29 | -0.60 ± 1.05 |
| Cough, Week 78 | 0.00 ± 1.26 | -0.30 ± 1.08 | -0.86 ± 1.12 |
| Cough, Week 79 | 0.00 ± 1.38 | -0.04 ± 1.04 | -0.61 ± 1.41 |
| Cough, Week 80 | 0.21 ± 1.07 | -0.45 ± 1.17 | -0.95 ± 1.13 |
| Cough, Week 81 | 0.08 ± 1.02 | -0.31 ± 1.14 | -0.72 ± 1.25 |
| Cough, Week 82 | 0.43 ± 1.17 | -0.33 ± 1.06 | -0.44 ± 1.13 |
| Cough, Week 83 | 0.30 ± 1.44 | -0.39 ± 1.06 | -1.00 ± 1.20 |
| Cough, Week 84 | 0.20 ± 1.30 | -0.10 ± 1.28 | -0.90 ± 1.26 |
| Cough, Week 85 | 1.00 ± 0.58 | -0.24 ± 1.13 | -0.60 ± 1.60 |
| Cough, Week 86 | 1.17 ± 0.58 | -0.27 ± 1.28 | -0.42 ± 1.32 |
| Cough, Week 87 | 0.83 ± 0.58 | 0.00 ± 1.30 | -0.94 ± 1.35 |
| Cough, Week 88 | 0.67 ± 0.76 | -0.37 ± 1.19 | -1.29 ± 1.41 |
| Cough, Week 89 | 0.83 ± 0.58 | -0.29 ± 1.17 | -1.14 ± 1.31 |
| Cough, Week 90 | 1.00 ± 0.50 | -0.35 ± 1.14 | -0.79 ± 1.29 |
| Cough, Week 91 | 0.67 ± 0.76 | -0.58 ± 1.19 | -0.93 ± 1.37 |
| Cough, Week 92 | 1.00 ± 0.58 | -0.19 ± 1.18 | -0.94 ± 1.37 |
| Cough, Week 93 | 1.00 ± 0.71 | -0.42 ± 1.26 | -0.90 ± 1.13 |
| Cough, Week 94 | 0.83 ± 0.58 | -0.41 ± 1.26 | -0.88 ± 1.25 |
| Cough, Week 95 | 0.83 ± 0.58 | 0.00 ± 1.28 | -0.81 ± 1.31 |
| Cough, Week 96 | 0.83 ± 0.58 | -0.18 ± 1.45 | -1.00 ± 1.31 |
| Cough, Week 97 | 1.00 ± 0.50 | -0.14 ± 1.12 | -0.78 ± 1.23 |
| Cough, Week 98 | 0.50 ± 0.50 | -0.35 ± 1.18 | -1.00 ± 1.29 |
| Cough, Week 99 | 0.83 ± 0.58 | 0.00 ± 1.41 | -0.64 ± 1.14 |
| Cough, Week 100 | 1.00 ± 0.71 | -0.35 ± 1.16 | -0.81 ± 1.25 |
| Cough, Week 101 | 0.83 ± 0.58 | -0.20 ± 1.32 | -0.79 ± 1.32 |
| Cough, Week 102 | 0.67 ± 0.76 | 0.00 ± 1.30 | -0.75 ± 1.44 |
| Cough, Week 103 | 0.50 ± 0.00 | -0.56 ± 1.07 | -0.67 ± 1.44 |
| Cough, Week 104 | 0.50 ± 0.00 | -0.38 ± 1.19 | 0.00 ± 1.08 |
| Cough, Week 105 | 0.50 ± 0.00 | 0.08 ± 0.80 | -0.25 ± 1.33 |
| Cough, Week 106 | 0.50 ± 0.00 | -0.28 ± 1.23 | -0.80 ± 1.04 |
| Cough, Week 107 | 0.25 ± 0.35 | -0.57 ± 1.48 | -1.25 ± 1.19 |
| Cough, Week 108 | 0.25 ± 0.35 | -0.70 ± 1.64 | -1.38 ± 1.11 |
| Cough, Week 109 | 0.50 ± 0.00 | -0.30 ± 1.82 | -0.75 ± 1.06 |
| Cough, Week 110 | 0.50 ± 0.00 | 0.50 ± 1.80 | -1.25 ± 1.04 |
| Cough, Week 111 | 0.75 ± 0.35 | -0.13 ± 1.93 | -1.25 ± 1.04 |
| Cough, Week 112 | 0.50 ± 0.00 | 0.17 ± 1.44 | -1.75 ± 0.35 |
| Cough, Week 113 | 0.50 | 0.13 ± 1.75 | -1.17 ± 1.04 |
| Cough, Week 114 | 0.25 ± 0.35 | 0.50 ± 1.80 | -1.50 ± 0.71 |
| Cough, Week 115 | 0.50 ± 0.00 | -0.88 ± 1.31 | -1.00 ± 1.00 |
| Cough, Week 116 | 0.75 ± 0.35 | -0.50 ± 1.32 | -1.33 ± 1.15 |
| Cough, Week 117 | 0.75 ± 0.35 | -0.25 ± 1.77 | -1.50 ± 0.71 |
| Cough, Week 118 | 0.50 | 1.00 | -1.50 ± 0.71 |
| Cough, Week 119 | — | 1.00 | -1.00 ± 0.71 |
| Cough, Week 120 | — | 1.00 | -1.00 ± 0.71 |
| Cough, Week 121 | — | 1.00 | -1.00 ± 0.71 |
| Cough, Week 122 | — | 1.00 | -1.25 ± 0.35 |
| Cough, Week 123 | — | 1.00 | -2.00 |
| Cough, Week 124 | — | 2.00 | -1.00 |
| Cough, Week 125 | — | — | -2.00 |
| Cough, Week 126 | — | — | -1.00 |
| Cough, Week 127 | — | — | -1.00 |
| Cough, Time of First Pd | -0.15 ± 1.05 | -0.16 ± 1.12 | -0.16 ± 1.05 |
| Cough, Time of Last Tx Dose | -0.31 ± 1.10 | -0.24 ± 1.09 | -0.21 ± 1.13 |
| Cough, Survival Follow-Up Month 1 | -0.03 ± 1.13 | — | — |
| Cough, Survival Follow-Up Month 2 | 0.03 ± 1.04 | — | — |
| Cough, Survival Follow-Up Month 3 | -0.18 ± 1.06 | — | — |
| Cough, Survival Follow-Up Month 4 | -0.09 ± 1.32 | — | — |
| Cough, Survival Follow-Up Month 5 | -0.04 ± 1.14 | — | — |
| Cough, Survival Follow-Up Month 6 | -0.17 ± 1.17 | — | — |
| Cough, Survival Follow-Up Month 7 | 1.33 ± 0.29 | — | — |
| Cough, Survival Follow-Up Month 8 | -0.50 ± 2.12 | — | — |
| Dyspnoea, Week 1 | 0.18 ± 0.80 | 0.11 ± 0.76 | 0.17 ± 0.73 |
| Dyspnoea, Week 2 | 0.13 ± 0.75 | 0.11 ± 0.86 | 0.27 ± 0.88 |
| Dyspnoea, Week 3 | 0.06 ± 0.83 | 0.16 ± 0.81 | 0.30 ± 0.89 |
| Dyspnoea, Week 4 | 0.17 ± 0.89 | 0.16 ± 0.83 | 0.26 ± 0.89 |
| Dyspnoea, Week 5 | 0.21 ± 0.89 | 0.25 ± 0.88 | 0.31 ± 0.85 |
| Dyspnoea, Week 6 | 0.17 ± 0.97 | 0.23 ± 0.83 | 0.29 ± 0.88 |
| Dyspnoea, Week 7 | 0.20 ± 0.98 | 0.25 ± 0.91 | 0.27 ± 0.96 |
| Dyspnoea, Week 8 | 0.26 ± 0.95 | 0.29 ± 0.91 | 0.31 ± 0.97 |
| Dyspnoea, Week 9 | 0.23 ± 0.97 | 0.26 ± 0.85 | 0.33 ± 0.98 |
| Dyspnoea, Week 10 | 0.37 ± 0.99 | 0.34 ± 0.94 | 0.34 ± 0.95 |
| Dyspnoea, Week 11 | 0.40 ± 0.95 | 0.31 ± 0.91 | 0.35 ± 0.97 |
| Dyspnoea, Week 12 | 0.44 ± 0.98 | 0.41 ± 1.01 | 0.29 ± 0.90 |
| Dyspnoea, Week 13 | 0.40 ± 1.03 | 0.32 ± 0.92 | 0.34 ± 0.94 |
| Dyspnoea, Week 14 | 0.42 ± 0.95 | 0.29 ± 0.92 | 0.34 ± 0.91 |
| Dyspnoea, Week 15 | 0.36 ± 0.98 | 0.32 ± 0.92 | 0.30 ± 0.91 |
| Dyspnoea, Week 16 | 0.45 ± 0.95 | 0.32 ± 0.93 | 0.36 ± 0.92 |
| Dyspnoea, Week 17 | 0.55 ± 0.99 | 0.25 ± 0.90 | 0.29 ± 0.91 |
| Dyspnoea, Week 18 | 0.46 ± 0.93 | 0.28 ± 0.93 | 0.34 ± 0.97 |
| Dyspnoea, Week 19 | 0.48 ± 0.97 | 0.28 ± 0.98 | 0.44 ± 0.96 |
| Dyspnoea, Week 20 | 0.37 ± 0.97 | 0.28 ± 0.93 | 0.24 ± 0.99 |
| Dyspnoea, Week 21 | 0.51 ± 0.94 | 0.23 ± 0.98 | 0.19 ± 1.00 |
| Dyspnoea, Week 22 | 0.50 ± 0.95 | 0.25 ± 0.96 | 0.24 ± 1.07 |
| Dyspnoea, Week 23 | 0.44 ± 0.94 | 0.30 ± 0.99 | 0.20 ± 0.98 |
| Dyspnoea, Week 24 | 0.25 ± 1.01 | 0.20 ± 0.91 | 0.29 ± 1.02 |
| Dyspnoea, Week 25 | 0.27 ± 0.94 | 0.18 ± 0.95 | 0.25 ± 1.00 |
| Dyspnoea, Week 26 | 0.20 ± 0.84 | 0.31 ± 0.96 | 0.39 ± 1.02 |
| Dyspnoea, Week 27 | 0.31 ± 0.80 | 0.21 ± 0.95 | 0.36 ± 1.14 |
| Dyspnoea, Week 28 | 0.24 ± 0.83 | 0.17 ± 0.86 | 0.30 ± 1.07 |
| Dyspnoea, Week 29 | 0.30 ± 0.82 | 0.19 ± 0.96 | 0.31 ± 1.07 |
| Dyspnoea, Week 30 | 0.30 ± 0.82 | 0.12 ± 0.94 | 0.39 ± 1.08 |
| Dyspnoea, Week 31 | 0.34 ± 0.76 | 0.18 ± 0.96 | 0.36 ± 1.12 |
| Dyspnoea, Week 32 | 0.28 ± 0.79 | 0.09 ± 0.84 | 0.26 ± 1.05 |
| Dyspnoea, Week 33 | 0.39 ± 0.74 | 0.02 ± 0.85 | 0.31 ± 1.05 |
| Dyspnoea, Week 34 | 0.32 ± 0.69 | 0.05 ± 0.76 | 0.30 ± 1.05 |
| Dyspnoea, Week 35 | 0.35 ± 0.88 | 0.04 ± 0.82 | 0.38 ± 1.05 |
| Dyspnoea, Week 36 | 0.32 ± 0.68 | 0.11 ± 0.82 | 0.37 ± 0.98 |
| Dyspnoea, Week 37 | 0.24 ± 0.76 | 0.16 ± 0.92 | 0.32 ± 0.92 |
| Dyspnoea, Week 38 | 0.31 ± 0.75 | 0.10 ± 0.78 | 0.40 ± 1.01 |
| Dyspnoea, Week 39 | 0.39 ± 0.76 | 0.04 ± 0.87 | 0.36 ± 1.01 |
| Dyspnoea, Week 40 | 0.38 ± 0.74 | 0.24 ± 0.92 | 0.37 ± 0.91 |
| Dyspnoea, Week 41 | 0.45 ± 0.92 | 0.13 ± 0.84 | 0.33 ± 0.89 |
| Dyspnoea, Week 42 | 0.37 ± 0.82 | 0.05 ± 0.81 | 0.29 ± 1.02 |
| Dyspnoea, Week 43 | 0.48 ± 0.94 | 0.16 ± 0.76 | 0.41 ± 1.05 |
| Dyspnoea, Week 44 | 0.22 ± 0.95 | 0.11 ± 0.88 | 0.33 ± 1.08 |
| Dyspnoea, Week 45 | 0.32 ± 1.04 | 0.20 ± 0.84 | 0.27 ± 1.07 |
| Dyspnoea, Week 46 | 0.36 ± 0.98 | 0.08 ± 0.78 | 0.26 ± 0.99 |
| Dyspnoea, Week 47 | 0.32 ± 0.85 | 0.06 ± 0.80 | 0.31 ± 1.01 |
| Dyspnoea, Week 48 | 0.32 ± 0.88 | 0.14 ± 0.85 | 0.22 ± 0.93 |
| Dyspnoea, Week 49 | 0.46 ± 0.99 | 0.06 ± 0.78 | 0.14 ± 0.93 |
| Dyspnoea, Week 50 | 0.41 ± 0.84 | 0.10 ± 0.85 | 0.06 ± 0.86 |
| Dyspnoea, Week 51 | 0.71 ± 0.92 | 0.08 ± 0.78 | 0.15 ± 1.06 |
| Dyspnoea, Week 52 | 0.60 ± 0.81 | 0.11 ± 0.86 | 0.34 ± 0.97 |
| Dyspnoea, Week 53 | 0.70 ± 0.85 | 0.11 ± 0.89 | 0.11 ± 1.11 |
| Dyspnoea, Week 54 | 0.71 ± 0.94 | 0.11 ± 0.80 | 0.10 ± 1.02 |
| Dyspnoea, Week 55 | 0.82 ± 0.93 | 0.15 ± 0.85 | 0.16 ± 1.08 |
| Dyspnoea, Week 56 | 0.69 ± 0.94 | 0.14 ± 0.95 | 0.12 ± 1.02 |
| Dyspnoea, Week 57 | 0.74 ± 0.80 | 0.12 ± 0.90 | 0.13 ± 1.03 |
| Dyspnoea, Week 58 | 0.80 ± 0.93 | 0.02 ± 0.98 | 0.12 ± 1.06 |
| Dyspnoea, Week 59 | 0.78 ± 1.09 | 0.11 ± 1.00 | -0.03 ± 1.04 |
| Dyspnoea, Week 60 | 0.67 ± 0.86 | 0.06 ± 0.93 | 0.02 ± 1.02 |
| Dyspnoea, Week 61 | 0.91 ± 0.91 | 0.05 ± 0.92 | -0.18 ± 0.93 |
| Dyspnoea, Week 62 | 0.58 ± 0.94 | 0.01 ± 0.96 | -0.04 ± 1.01 |
| Dyspnoea, Week 63 | 0.58 ± 1.14 | 0.10 ± 0.95 | -0.06 ± 0.72 |
| Dyspnoea, Week 64 | 0.63 ± 0.98 | 0.07 ± 1.08 | -0.22 ± 0.74 |
| Dyspnoea, Week 65 | 0.80 ± 1.06 | 0.05 ± 1.05 | -0.18 ± 0.87 |
| Dyspnoea, Week 66 | 0.70 ± 1.02 | 0.04 ± 1.07 | -0.18 ± 0.85 |
| Dyspnoea, Week 67 | 0.52 ± 0.95 | 0.04 ± 1.15 | -0.24 ± 0.97 |
| Dyspnoea, Week 68 | 0.63 ± 0.98 | 0.01 ± 1.07 | -0.11 ± 0.86 |
| Dyspnoea, Week 69 | 0.96 ± 0.59 | 0.06 ± 1.19 | -0.20 ± 0.87 |
| Dyspnoea, Week 70 | 1.00 ± 0.60 | 0.16 ± 1.08 | -0.18 ± 0.94 |
| Dyspnoea, Week 71 | 0.70 ± 0.91 | 0.22 ± 1.08 | -0.01 ± 0.82 |
| Dyspnoea, Week 72 | 0.57 ± 0.98 | 0.25 ± 1.16 | -0.06 ± 0.79 |
| Dyspnoea, Week 73 | 0.67 ± 1.07 | 0.10 ± 1.18 | -0.11 ± 0.79 |
| Dyspnoea, Week 74 | 0.74 ± 0.96 | 0.10 ± 1.15 | -0.17 ± 0.86 |
| Dyspnoea, Week 75 | 0.70 ± 0.99 | 0.05 ± 1.13 | -0.22 ± 0.81 |
| Dyspnoea, Week 76 | 0.67 ± 0.90 | 0.25 ± 1.33 | -0.13 ± 0.90 |
| Dyspnoea, Week 77 | 0.73 ± 0.95 | 0.04 ± 1.36 | 0.12 ± 0.76 |
| Dyspnoea, Week 78 | 0.57 ± 0.94 | 0.09 ± 1.24 | -0.20 ± 0.95 |
| Dyspnoea, Week 79 | 0.57 ± 0.77 | 0.16 ± 1.29 | -0.13 ± 0.93 |
| Dyspnoea, Week 80 | 0.60 ± 0.78 | -0.13 ± 1.17 | 0.00 ± 0.81 |
| Dyspnoea, Week 81 | 0.50 ± 0.92 | -0.02 ± 1.17 | -0.04 ± 0.86 |
| Dyspnoea, Week 82 | 0.57 ± 0.91 | -0.05 ± 1.16 | 0.00 ± 0.90 |
| Dyspnoea, Week 83 | 0.28 ± 0.69 | -0.08 ± 1.26 | -0.40 ± 0.98 |
| Dyspnoea, Week 84 | 0.16 ± 0.59 | -0.17 ± 1.23 | -0.22 ± 0.99 |
| Dyspnoea, Week 85 | 0.70 ± 0.50 | -0.16 ± 1.11 | -0.16 ± 1.03 |
| Dyspnoea, Week 86 | 1.33 ± 1.45 | -0.23 ± 1.12 | -0.17 ± 1.26 |
| Dyspnoea, Week 87 | 0.40 ± 0.40 | 0.08 ± 1.45 | -0.25 ± 1.06 |
| Dyspnoea, Week 88 | 0.40 ± 0.69 | -0.21 ± 1.06 | -0.51 ± 1.06 |
| Dyspnoea, Week 89 | 0.53 ± 0.42 | -0.13 ± 1.02 | -0.06 ± 1.12 |
| Dyspnoea, Week 90 | 0.27 ± 0.31 | -0.32 ± 0.99 | -0.17 ± 1.07 |
| Dyspnoea, Week 91 | 0.33 ± 0.31 | -0.52 ± 0.81 | -0.17 ± 1.13 |
| Dyspnoea, Week 92 | 0.75 ± 0.66 | -0.28 ± 1.02 | -0.10 ± 1.06 |
| Dyspnoea, Week 93 | 0.40 ± 0.28 | -0.23 ± 0.93 | -0.14 ± 0.90 |
| Dyspnoea, Week 94 | 0.67 ± 0.70 | -0.38 ± 0.85 | -0.25 ± 0.98 |
| Dyspnoea, Week 95 | 0.53 ± 0.23 | -0.07 ± 1.21 | -0.20 ± 1.04 |
| Dyspnoea, Week 96 | 0.33 ± 0.42 | -0.02 ± 1.21 | -0.18 ± 1.09 |
| Dyspnoea, Week 97 | 0.67 ± 0.42 | -0.22 ± 1.18 | 0.04 ± 1.13 |
| Dyspnoea, Week 98 | 0.73 ± 0.50 | -0.18 ± 1.19 | -0.29 ± 1.08 |
| Dyspnoea, Week 99 | 0.47 ± 0.46 | -0.26 ± 1.25 | -0.29 ± 1.09 |
| Dyspnoea, Week 100 | 0.50 ± 0.42 | -0.24 ± 1.24 | -0.20 ± 1.08 |
| Dyspnoea, Week 101 | 0.40 ± 0.35 | -0.26 ± 1.23 | -0.03 ± 1.09 |
| Dyspnoea, Week 102 | 0.40 ± 0.35 | -0.67 ± 0.89 | 0.00 ± 1.08 |
| Dyspnoea, Week 103 | 0.70 ± 0.42 | -0.60 ± 0.73 | -0.03 ± 1.24 |
| Dyspnoea, Week 104 | 0.50 ± 0.71 | -0.63 ± 0.82 | -0.35 ± 1.42 |
| Dyspnoea, Week 105 | 0.40 ± 0.57 | -0.20 ± 0.33 | 0.23 ± 0.92 |
| Dyspnoea, Week 106 | 0.30 ± 0.42 | -0.24 ± 0.31 | -0.04 ± 0.57 |
| Dyspnoea, Week 107 | 0.60 ± 0.28 | -0.17 ± 0.35 | -0.30 ± 0.74 |
| Dyspnoea, Week 108 | 0.60 ± 0.28 | -0.36 ± 0.43 | -0.40 ± 0.88 |
| Dyspnoea, Week 109 | 0.80 ± 0.00 | -0.40 ± 0.47 | 0.10 ± 0.99 |
| Dyspnoea, Week 110 | 0.60 ± 0.28 | -0.27 ± 0.50 | -0.40 ± 0.94 |
| Dyspnoea, Week 111 | 0.30 ± 0.42 | -0.15 ± 0.34 | -0.45 ± 0.91 |
| Dyspnoea, Week 112 | 0.50 ± 0.42 | -0.20 ± 0.40 | -1.30 ± 0.14 |
| Dyspnoea, Week 113 | 1.00 | -0.35 ± 0.44 | -0.47 ± 1.14 |
| Dyspnoea, Week 114 | 0.50 ± 0.71 | -0.27 ± 0.50 | -1.30 ± 0.14 |
| Dyspnoea, Week 115 | 0.50 ± 0.71 | -0.40 ± 0.28 | -0.67 ± 1.10 |
| Dyspnoea, Week 116 | 0.40 ± 0.57 | -0.20 ± 0.53 | -0.73 ± 1.17 |
| Dyspnoea, Week 117 | 0.40 ± 0.28 | -0.60 ± 0.28 | -1.20 ± 0.28 |
| Dyspnoea, Week 118 | 1.00 | -0.80 | -1.20 ± 0.57 |
| Dyspnoea, Week 119 | — | -0.80 | -1.40 ± 0.28 |
| Dyspnoea, Week 120 | — | -0.80 | -1.10 ± 0.42 |
| Dyspnoea, Week 121 | — | -0.80 | -1.30 ± 0.14 |
| Dyspnoea, Week 122 | — | -0.80 | -1.30 ± 0.14 |
| Dyspnoea, Week 123 | — | -0.80 | -1.00 |
| Dyspnoea, Week 124 | — | -0.80 | -1.20 |
| Dyspnoea, Week 125 | — | — | -1.00 |
| Dyspnoea, Week 126 | — | — | -1.20 |
| Dyspnoea, Week 127 | — | — | -1.20 |
| Dyspnoea, Time of First Pd | 0.38 ± 1.06 | 0.42 ± 0.95 | 0.27 ± 1.13 |
| Dyspnoea, Time of Last Tx Dose | 0.43 ± 0.91 | 0.28 ± 1.01 | 0.28 ± 1.00 |
| Dyspnoea, Survival Follow-Up Month 1 | 0.56 ± 1.09 | — | — |
| Dyspnoea, Survival Follow-Up Month 2 | 0.71 ± 0.89 | — | — |
| Dyspnoea, Survival Follow-Up Month 3 | 0.67 ± 1.06 | — | — |
| Dyspnoea, Survival Follow-Up Month 4 | 0.57 ± 0.91 | — | — |
| Dyspnoea, Survival Follow-Up Month 5 | 0.66 ± 1.02 | — | — |
| Dyspnoea, Survival Follow-Up Month 6 | 0.63 ± 1.09 | — | — |
| Dyspnoea, Survival Follow-Up Month 7 | 1.07 ± 1.36 | — | — |
| Dyspnoea, Survival Follow-Up Month 8 | 0.10 ± 0.14 | — | — |
PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the ITT Population Arm A and Arm B.
| Months | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|
| PFS as Determined by the Investigator Using RECIST v1.1 in the ITT Population (Arm A and Arm B) | 6.5 (5.7 to 7.1) | 5.6 (5.5 to 6.9) |
OS is defined as the time between the date of randomization and date of death from any cause in the ITT Population, Arm A and Arm B.
| Months | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|
| OS in the ITT Population (Arm A and Arm B) | 14.2 (12.3 to 16.8) | 12.6 (11.6 to 14.7) |
Percentage of participants with at least one adverse event.
| Percentage of participants | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|---|
| Percentage of Participants With Adverse Events | 97.0 | 99.4 | 97.9 |
Percentage of participants with Anti-therapeutic Antibody (ATA) response to atezolizumab.
| Percentage of participants | Arm A: Atezolizumab + Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin |
|---|---|---|
| Baseline evaluable participants | 3.1 | 1.9 |
| Post-baseline evaluable participants | 48.1 | 21.4 |
Maximum observed serum atezolizumab concentration (Cmax). The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.
| µg/mL | Arm A: Atezolizumab + Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin |
|---|---|---|
| Cycle 1 Day 1 Post dose | 372 ± 116 | 378 ± 124 |
| Cycle 3 Day 1 Post dose | 470 ± 147 | 444 ± 119 |
Minimum observed serum atezolizumab concentration (Cmin). The predose samples will be collected on the same day of treatment administration.
| µg/mL | Arm A: Atezolizumab + Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin |
|---|---|---|
| Cycle 1 Day 1 | NA ± NA | NA ± NA |
| Cycle 2 Day 1 | 63.9 ± 29.9 | 69.5 ± 34.7 |
| Cycle 3 Day 1 | 103 ± 40.1 | 107 ± 52.0 |
| Cycle 4 Day 1 | 128 ± 62.3 | 126 ± 68.4 |
| Cycle 8 Day 1 | 188 ± 80.4 | 190 ± 84.6 |
| Cycle 16 Day 1 | 201 ± 79.2 | 212 ± 78.1 |
| Cycle 24 Day 1 | 187 ± 90.4 | 224 ± 134 |
| Cycle 32 Day 1 | 242 ± 88.4 | 210 ± 102 |
| Cycle 40 Day 1 | 308 ± 141 | 174 ± NA |
| Treatment Discontinuation Visit | 126 ± 93.7 | 137 ± 103 |
| Day 120 Post Last Dose | 7.81 ± 9.76 | 9.47 ± 13.1 |
Plasma concentrations for paclitaxel.
| ng/mL | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|
| Cycle 1 Day 1 Prior to Infusion | NA ± NA |
| Cycle 1 Day 1 Before end of Infusion | 5860 ± 2410 |
| Cycle 1 Day 1 After Infusion | 2960 ± 2770 |
| Cycle 3 Day 1 Prior to Infusion | NA ± NA |
| Cycle 3 Day 1 Before end of Infusion | 21900 ± 42600 |
| Cycle 3 Day 1 After Infusion | 11000 ± 30700 |
Plasma concentrations for nab-paclitaxel.
| ng/mL | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm C: Nab-Paclitaxel + Carboplatin |
|---|---|---|
| Cycle 1 Day 1 Prior to Infusion | NA ± NA | NA ± NA |
| Cycle 1 Day 1 Before End of Infusion | 3330 ± 3680 | 8160 ± 20900 |
| Cycle 1 Day 1 After Infusion | 735 ± 1300 | 921 ± 2080 |
| Cycle 3 Day 1 Prior to Infusion | NA ± NA | NA ± NA |
| Cycle 3 Day 1 Before End of Infusion | 7160 ± 12300 | 7180 ± 14400 |
| Cycle 3 Day 1 After Infusion | 296 ± 274 | 1140 ± 2070 |
Plasma concentrations for carboplatin.
| ng/mL | Arm A: Atezolizumab + Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm C: Nab-Paclitaxel + Carboplatin |
|---|---|---|---|
| Cycle 1 Day 1 Prior to Infusion | NA ± NA | NA ± NA | NA ± NA |
| Cycle 1 Day 1 Before End of Infusion | 21100 ± 12400 | 15900 ± 9270 | 24900 ± 38200 |
| Cycle 1 Day 1 After Infusion | 11900 ± 6410 | 9890 ± 4780 | 10800 ± 6230 |
| Cycle 3 Day 1 Prior to Infusion | 238 ± 276 | 147 ± 60.9 | 161 ± 70.0 |
| Cycle 3 Day 1 Before End of Infusion | 33800 ± 38600 | 23500 ± 21600 | 26800 ± 31900 |
| Cycle 3 Day 1 After Infusion | 20000 ± 30900 | 11200 ± 5160 | 14700 ± 14600 |
Collected over From the first study drug administration to the data cutoff date: 17 February 2021 (up to approximately 68 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm C: Nab-Paclitaxel + Carboplatin | 252/340 (74.1%) | 96/334 (28.7%) | 315/334 (94.3%) |
| Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | 245/343 (71.4%) | 168/334 (50.3%) | 325/334 (97.3%) |
| Arm A: Atezolizumab + Paclitaxel + Carboplatin | 243/338 (71.9%) | 151/332 (45.5%) | 315/332 (94.9%) |
| Event | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|---|
| PNEUMONIAInfections and infestations | 21/334 | 33/334 | 30/332 |
| FEBRILE NEUTROPENIABlood and lymphatic system disorders | 5/334 | 13/334 | 16/332 |
| SEPSISInfections and infestations | 6/334 | 5/334 | 10/332 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASERespiratory, thoracic and mediastinal disorders | 3/334 | 7/334 | 10/332 |
| PNEUMONITISRespiratory, thoracic and mediastinal disorders | 2/334 | 10/334 | 10/332 |
| DYSPNOEARespiratory, thoracic and mediastinal disorders | 3/334 | 7/334 | 8/332 |
| DEATHGeneral disorders | 0/334 | 8/334 | 2/332 |
| PULMONARY EMBOLISMRespiratory, thoracic and mediastinal disorders | 3/334 | 3/334 | 7/332 |
| ANAEMIABlood and lymphatic system disorders | 3/334 | 7/334 | 6/332 |
| ATRIAL FIBRILLATIONCardiac disorders | 3/334 | 2/334 | 6/332 |
| Event | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin |
|---|---|---|---|
| ANAEMIABlood and lymphatic system disorders | 193/334 | 188/334 | 131/332 |
| NAUSEAGastrointestinal disorders | 97/334 | 131/334 | 94/332 |
| ALOPECIASkin and subcutaneous tissue disorders | 102/334 | 114/334 | 130/332 |
| NEUTROPENIABlood and lymphatic system disorders | 124/334 | 121/334 | 43/332 |
| FATIGUEGeneral disorders | 88/334 | 107/334 | 97/332 |
| CONSTIPATIONGastrointestinal disorders | 73/334 | 101/334 | 75/332 |
| DIARRHOEAGastrointestinal disorders | 77/334 | 92/334 | 94/332 |
| DECREASED APPETITEMetabolism and nutrition disorders | 84/334 | 82/334 | 93/332 |
| THROMBOCYTOPENIABlood and lymphatic system disorders | 92/334 | 91/334 | 46/332 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 33/334 | 53/334 | 78/332 |
| Age, Continuous(Years) | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin | Total |
|---|---|---|---|---|
| Mean | 64.9 ± 8.1 | 64.0 ± 9.2 | 65.0 ± 8.3 | 64.6 ± 8.6 |
| Sex: Female, Male(Participants) | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin | Total |
|---|---|---|---|---|
| Female | 63 | 63 | 60 | 186 |
| Male | 277 | 280 | 278 | 835 |
| Ethnicity (NIH/OMB)(Participants) | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin | Total |
|---|---|---|---|---|
| Hispanic or Latino | 24 | 27 | 28 | 79 |
| Not Hispanic or Latino | 299 | 306 | 297 | 902 |
| Unknown or Not Reported | 17 | 10 | 13 | 40 |
| Race (NIH/OMB)(Participants) | Arm C: Nab-Paclitaxel + Carboplatin | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Arm A: Atezolizumab + Paclitaxel + Carboplatin | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 3 | 5 |
| Asian | 37 | 41 | 34 | 112 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 1 |
| Black or African American | 7 | 4 | 3 | 14 |
| White | 290 | 289 | 290 | 869 |
| More than one race | 1 | 6 | 1 | 8 |
| Unknown or Not Reported | 4 | 2 | 6 | 12 |
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