Trial Outcomes & Findings for Testing the Addition of a New Immunotherapy Drug, Atezolizumab (MPDL3280A), to the Usual Chemoradiation (CRT) Therapy Treatment for Limited Stage Small Cell Lung Cancer (LS-SCLC) (NCT NCT03811002)
NCT ID: NCT03811002
Last Updated: 2025-12-03
Results Overview
Survival rates and median survival time are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
544 participants
Primary outcome timeframe
Randomization to date of death due or last follow-up. Median follow-up at the time of analysis was 23.8 months.
Results posted on
2025-12-03
Participant Flow
Participant milestones
| Measure |
Arm I (Chemotherapy, Radiation Therapy)
Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or intensity-modulated radiation therapy (IMRT) twice daily (BID) for approximately 3 weeks or once daily (QD) for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)
Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
|---|---|---|
|
Overall Study
STARTED
|
270
|
274
|
|
Overall Study
Adverse Event Population
|
257
|
264
|
|
Overall Study
Intent-to-treat (ITT)
|
270
|
274
|
|
Overall Study
COMPLETED
|
270
|
274
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants with data
Baseline characteristics by cohort
| Measure |
Arm I (Chemotherapy, Radiation Therapy)
n=270 Participants
Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)
n=274 Participants
Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
Total
n=544 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=270 Participants
|
66 years
n=274 Participants
|
66 years
n=544 Participants
|
|
Age, Customized
≤ 49
|
11 Participants
n=270 Participants
|
5 Participants
n=274 Participants
|
16 Participants
n=544 Participants
|
|
Age, Customized
50 - 59
|
49 Participants
n=270 Participants
|
49 Participants
n=274 Participants
|
98 Participants
n=544 Participants
|
|
Age, Customized
60 - 69
|
115 Participants
n=270 Participants
|
127 Participants
n=274 Participants
|
242 Participants
n=544 Participants
|
|
Age, Customized
≥ 70
|
95 Participants
n=270 Participants
|
93 Participants
n=274 Participants
|
188 Participants
n=544 Participants
|
|
Sex: Female, Male
Female
|
137 Participants
n=270 Participants
|
140 Participants
n=274 Participants
|
277 Participants
n=544 Participants
|
|
Sex: Female, Male
Male
|
133 Participants
n=270 Participants
|
134 Participants
n=274 Participants
|
267 Participants
n=544 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=270 Participants
|
7 Participants
n=274 Participants
|
16 Participants
n=544 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
257 Participants
n=270 Participants
|
261 Participants
n=274 Participants
|
518 Participants
n=544 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=270 Participants
|
6 Participants
n=274 Participants
|
10 Participants
n=544 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=270 Participants
|
0 Participants
n=274 Participants
|
1 Participants
n=544 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=270 Participants
|
28 Participants
n=274 Participants
|
47 Participants
n=544 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=270 Participants
|
0 Participants
n=274 Participants
|
1 Participants
n=544 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=270 Participants
|
24 Participants
n=274 Participants
|
46 Participants
n=544 Participants
|
|
Race (NIH/OMB)
White
|
221 Participants
n=270 Participants
|
215 Participants
n=274 Participants
|
436 Participants
n=544 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=270 Participants
|
0 Participants
n=274 Participants
|
2 Participants
n=544 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=270 Participants
|
7 Participants
n=274 Participants
|
11 Participants
n=544 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
121 Participants
n=270 Participants
|
120 Participants
n=274 Participants
|
241 Participants
n=544 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
136 Participants
n=270 Participants
|
142 Participants
n=274 Participants
|
278 Participants
n=544 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
13 Participants
n=270 Participants
|
12 Participants
n=274 Participants
|
25 Participants
n=544 Participants
|
|
Platinum regimen (as randomized)
Carboplatin
|
111 Participants
n=270 Participants
|
111 Participants
n=274 Participants
|
222 Participants
n=544 Participants
|
|
Platinum regimen (as randomized)
Cisplatin
|
159 Participants
n=270 Participants
|
163 Participants
n=274 Participants
|
322 Participants
n=544 Participants
|
|
RT Schedule (as randomized)
Twice a day (3 weeks)
|
128 Participants
n=270 Participants
|
129 Participants
n=274 Participants
|
257 Participants
n=544 Participants
|
|
RT Schedule (as randomized)
Daily (6.5 weeks)
|
142 Participants
n=270 Participants
|
145 Participants
n=274 Participants
|
287 Participants
n=544 Participants
|
|
T-Stage
T0 (No primary tumor)
|
3 Participants
n=270 Participants
|
2 Participants
n=274 Participants
|
5 Participants
n=544 Participants
|
|
T-Stage
T1 (Tumor ≤3 cm in size)
|
96 Participants
n=270 Participants
|
89 Participants
n=274 Participants
|
185 Participants
n=544 Participants
|
|
T-Stage
T2 (Tumor >3 cm but ≤5 cm or involves main bronchus, visceral pleura, or causes lung collapse.)
|
58 Participants
n=270 Participants
|
60 Participants
n=274 Participants
|
118 Participants
n=544 Participants
|
|
T-Stage
T3 (Tumor >5 cm but ≤7 cm or multiple tumors in the same lobe.)
|
57 Participants
n=270 Participants
|
62 Participants
n=274 Participants
|
119 Participants
n=544 Participants
|
|
T-Stage
T4 (Tumor >7 cm or invades nearby structures or has multiple tumors in different lobes.)
|
46 Participants
n=270 Participants
|
52 Participants
n=274 Participants
|
98 Participants
n=544 Participants
|
|
T-Stage
TX (Primary tumor cannot be assessed)
|
10 Participants
n=270 Participants
|
9 Participants
n=274 Participants
|
19 Participants
n=544 Participants
|
|
N-Stage
N0: No regional lymph node involvement.
|
20 Participants
n=270 Participants
|
26 Participants
n=274 Participants
|
46 Participants
n=544 Participants
|
|
N-Stage
N1: Cancer in nearby lymph nodes.
|
43 Participants
n=270 Participants
|
40 Participants
n=274 Participants
|
83 Participants
n=544 Participants
|
|
N-Stage
N2: Cancer in lymph nodes in the center of the chest (mediastinum).
|
147 Participants
n=270 Participants
|
148 Participants
n=274 Participants
|
295 Participants
n=544 Participants
|
|
N-Stage
N3: Cancer in lymph nodes on the opposite side of the chest or above the collarbone.
|
58 Participants
n=270 Participants
|
59 Participants
n=274 Participants
|
117 Participants
n=544 Participants
|
|
N-Stage
NX: Cannot be assessed
|
2 Participants
n=270 Participants
|
1 Participants
n=274 Participants
|
3 Participants
n=544 Participants
|
|
American Joint Committee on Cancer (AJCC) Stage
IA: T1, N0, M0
|
7 Participants
n=270 Participants
|
7 Participants
n=274 Participants
|
14 Participants
n=544 Participants
|
|
American Joint Committee on Cancer (AJCC) Stage
IB: T2b, N0, M0
|
3 Participants
n=270 Participants
|
4 Participants
n=274 Participants
|
7 Participants
n=544 Participants
|
|
American Joint Committee on Cancer (AJCC) Stage
IIA: T2b, N0, M0
|
2 Participants
n=270 Participants
|
4 Participants
n=274 Participants
|
6 Participants
n=544 Participants
|
|
American Joint Committee on Cancer (AJCC) Stage
IIB: T1a-c or T2a-b, N1, M0; or T3, N0, M0.
|
38 Participants
n=270 Participants
|
34 Participants
n=274 Participants
|
72 Participants
n=544 Participants
|
|
American Joint Committee on Cancer (AJCC) Stage
IIIA: T1a-c or T2a-b, N2, M0; or T3, N1, M0; or T4, N0-1, M0.
|
107 Participants
n=270 Participants
|
112 Participants
n=274 Participants
|
219 Participants
n=544 Participants
|
|
American Joint Committee on Cancer (AJCC) Stage
IIIB: T1a-c or T2a-b, N3, M0; or T3, N2, M0; or T4, N2, M0.
|
87 Participants
n=270 Participants
|
77 Participants
n=274 Participants
|
164 Participants
n=544 Participants
|
|
American Joint Committee on Cancer (AJCC) Stage
IIIC: T3 or T4, N3, M0
|
26 Participants
n=270 Participants
|
36 Participants
n=274 Participants
|
62 Participants
n=544 Participants
|
|
Primary tumor location
Right Upper Lobe
|
75 Participants
n=270 Participants
|
80 Participants
n=274 Participants
|
155 Participants
n=544 Participants
|
|
Primary tumor location
Left Upper Lobe
|
61 Participants
n=270 Participants
|
68 Participants
n=274 Participants
|
129 Participants
n=544 Participants
|
|
Primary tumor location
Right Lower Lobe
|
33 Participants
n=270 Participants
|
35 Participants
n=274 Participants
|
68 Participants
n=544 Participants
|
|
Primary tumor location
Left Lower Lobe
|
29 Participants
n=270 Participants
|
28 Participants
n=274 Participants
|
57 Participants
n=544 Participants
|
|
Primary tumor location
Mediastinum
|
20 Participants
n=270 Participants
|
19 Participants
n=274 Participants
|
39 Participants
n=544 Participants
|
|
Primary tumor location
Other
|
16 Participants
n=270 Participants
|
17 Participants
n=274 Participants
|
33 Participants
n=544 Participants
|
|
Primary tumor location
Right Middle Lobe
|
16 Participants
n=270 Participants
|
13 Participants
n=274 Participants
|
29 Participants
n=544 Participants
|
|
Primary tumor location
Multiple Sites
|
7 Participants
n=270 Participants
|
6 Participants
n=274 Participants
|
13 Participants
n=544 Participants
|
|
Primary tumor location
Lingula
|
4 Participants
n=270 Participants
|
5 Participants
n=274 Participants
|
9 Participants
n=544 Participants
|
|
Primary tumor location
Carina
|
4 Participants
n=270 Participants
|
1 Participants
n=274 Participants
|
5 Participants
n=544 Participants
|
|
Primary tumor location
Main Bronchus, Left
|
2 Participants
n=270 Participants
|
2 Participants
n=274 Participants
|
4 Participants
n=544 Participants
|
|
Primary tumor location
Main Bronchus, Right
|
2 Participants
n=270 Participants
|
0 Participants
n=274 Participants
|
2 Participants
n=544 Participants
|
|
Primary tumor location
Undetectable Primary
|
1 Participants
n=270 Participants
|
0 Participants
n=274 Participants
|
1 Participants
n=544 Participants
|
|
Forced Expiratory Volume in 1 second (FEV1)
|
1.96 liters/second
n=255 Participants • Participants with data
|
1.99 liters/second
n=261 Participants • Participants with data
|
1.98 liters/second
n=516 Participants • Participants with data
|
|
Percentage of Predicted FEV1
|
71 percentage of predicted value
n=255 Participants • Participants with data
|
74 percentage of predicted value
n=263 Participants • Participants with data
|
72 percentage of predicted value
n=518 Participants • Participants with data
|
|
Percentage of Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
|
67.5 percentage of predicted value
n=248 Participants • Participants with data
|
66 percentage of predicted value
n=257 Participants • Participants with data
|
66 percentage of predicted value
n=505 Participants • Participants with data
|
|
Cigarette use
Current
|
78 Participants
n=270 Participants
|
88 Participants
n=274 Participants
|
166 Participants
n=544 Participants
|
|
Cigarette use
Former
|
185 Participants
n=270 Participants
|
181 Participants
n=274 Participants
|
366 Participants
n=544 Participants
|
|
Cigarette use
Never
|
7 Participants
n=270 Participants
|
5 Participants
n=274 Participants
|
12 Participants
n=544 Participants
|
PRIMARY outcome
Timeframe: Randomization to date of death due or last follow-up. Median follow-up at the time of analysis was 23.8 months.Population: Intent-to-treat population
Survival rates and median survival time are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.
Outcome measures
| Measure |
Arm I (Chemotherapy, Radiation Therapy)
n=270 Participants
Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)
n=274 Participants
Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
|---|---|---|
|
Overall Survival
|
36.1 months
Interval 28.1 to 42.5
|
31.1 months
Interval 28.5 to 44.7
|
SECONDARY outcome
Timeframe: From randomization to progression or death due to any cause, whichever occurs first, or last tumor assessment if alive. MMedian follow-up at the time of analysis was 23.8 months.Population: Intent-to-treat population
PFS failure event is defined as progressive disease (PD) determined by investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause. PD is defined as at least a 20% increase in the sum of longest diameters of target lesions, and an absolute increase of at least 5 mm. The appearance of any new lesions is also considered progression. PFS rates and median PFS time are estimated using the Kaplan-Meier method, censoring participants alive without progression at the date of their last evaluable radiographic tumor assessment.
Outcome measures
| Measure |
Arm I (Chemotherapy, Radiation Therapy)
n=270 Participants
Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)
n=274 Participants
Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
11.4 months
Interval 10.3 to 13.2
|
12.1 months
Interval 10.9 to 15.2
|
SECONDARY outcome
Timeframe: Randomization to last follow-up. Median follow-up at the time of analysis was 23.8 months.Population: Adverse event population
Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Outcome measures
| Measure |
Arm I (Chemotherapy, Radiation Therapy)
n=257 Participants
Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)
n=264 Participants
Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
|---|---|---|
|
Number of Participants by Highest Grade Adverse Event Reported
Overall · Grade 2
|
8 Participants
|
9 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Overall · Grade 3
|
56 Participants
|
63 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Overall · Grade 4
|
182 Participants
|
168 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Overall · Grade 5
|
4 Participants
|
24 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Immune-mediated · None reported
|
210 Participants
|
125 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Immune-mediated · Grade 1
|
19 Participants
|
29 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Immune-mediated · Grade 2
|
11 Participants
|
63 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Immune-mediated · Grade 3
|
14 Participants
|
31 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Immune-mediated · Grade 5
|
0 Participants
|
4 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Non-Immune-Mediated · None reported
|
4 Participants
|
0 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Non-Immune-Mediated · Grade 1
|
3 Participants
|
0 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Non-Immune-Mediated · Grade 2
|
8 Participants
|
10 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Non-Immune-Mediated · Grade 3
|
57 Participants
|
66 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Non-Immune-Mediated · Grade 4
|
181 Participants
|
168 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Non-Immune-Mediated · Grade 5
|
4 Participants
|
20 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Overall · None reported
|
4 Participants
|
0 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Overall · Grade 1
|
3 Participants
|
0 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Immune-mediated · Grade 4
|
3 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Randomization to last radiographic tumor assessment. Median follow-up at the time of analysis was 23.8 months.Population: Intent-to-treat population
Objective response rate (ORR) is defined as the proportion of subjects whose best overall response (BOR) is a confirmed complete or partial response as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 on two consecutive occasions ≥4 weeks apart.
Outcome measures
| Measure |
Arm I (Chemotherapy, Radiation Therapy)
n=270 Participants
Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)
n=274 Participants
Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
|---|---|---|
|
Percentage of Participants With Confirmed Objective Response (Objective Response Rate (ORR))
|
59.6 percentage of participants
Interval 53.5 to 65.5
|
60.2 percentage of participants
Interval 54.2 to 66.1
|
SECONDARY outcome
Timeframe: From randomization to local progression, other progression, or death, whichever occurs first, or last tumor assessment if alive. Median follow-up at the time of analysis was 23.8 months. 1-, 2-, and 3-year rates are reported.Population: Intent-to-treat population
Local progression is defined as intrathoracic tumor progression (failure in the lobe of the primary tumor or mediastinal lymph nodes) by RECIST 1.1 criteria determined by the investigator. Local progression rates are estimated by the cumulative incidence method, treating non-local progression (i.e., distant metastasis or failure in a different lung) and death without local progression as competing risks, and otherwise censoring participants alive at last tumor assessment. Treatment effect comparisons will utilize a cause-specific hazard function in which competing risks are censored.
Outcome measures
| Measure |
Arm I (Chemotherapy, Radiation Therapy)
n=270 Participants
Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)
n=274 Participants
Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
|---|---|---|
|
Percentage of Participants With Local Progression
3 years
|
14.3 percentage of participants
Interval 10.1 to 19.3
|
12.8 percentage of participants
Interval 8.8 to 17.5
|
|
Percentage of Participants With Local Progression
1 year
|
10.1 percentage of participants
Interval 6.6 to 14.4
|
8.1 percentage of participants
Interval 5.0 to 12.0
|
|
Percentage of Participants With Local Progression
2 years
|
14.3 percentage of participants
Interval 10.1 to 19.3
|
12.8 percentage of participants
Interval 8.8 to 17.5
|
SECONDARY outcome
Timeframe: Randomization to DMFS event or local progression, whichever occurs first, or last tumor assessment if alive. Median follow-up at the time of analysis was 23.8 months.Population: Intent-to-treat population
DMFS failure event is defined as first date of documented distant metastases (or failures in a different lung lobe) or death due to any cause, whichever occurs first. Participants with local progression prior to such an event are censored on the date of local progression. Participants with no post-baseline tumor assessment and alive at last follow-up are censored on the date of randomization. Participants alive without distant metastasis, failures in a different lung lobe, or local progression are censored on the date of their last evaluable radiographic tumor assessment. DMFS rates and median DMFS time are estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Arm I (Chemotherapy, Radiation Therapy)
n=270 Participants
Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)
n=274 Participants
Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
|---|---|---|
|
Distant Metastases-free Survival (DMFS)
|
13.0 months
Interval 11.3 to 18.2
|
16.8 months
Interval 12.1 to 21.6
|
SECONDARY outcome
Timeframe: Baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization)Population: Intent-to-treat participants with FACT-TOI at baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization).
FACT-TOI is a measure of 21 items that sums the functional well-being (FWB), physical well-being (PWB), and the lung cancer subscale (LCS) of the Functional Assessment of Cancer Therapy - Lung (FACT-L) quality of life (QOL) instrument. The FACT-TOI total score ranges from 0 to 84 with higher scores indicating better quality of life and functioning. Clinically meaningful decline is defined as a decrease from baseline of at least 5 points.
Outcome measures
| Measure |
Arm I (Chemotherapy, Radiation Therapy)
n=102 Participants
Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)
n=110 Participants
Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
|---|---|---|
|
Percent of Participants With Deterioration in Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI)
|
33 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Baseline to death, last follow-up or two years, whichever occurs first.Population: Eligible participants with baseline EQ-5D-5L index score and at least one follow-up EQ-5D-5L index score.
Quality-adjusted survival is calculated as the sum of weighted time intervals. Weight is the EuroQol 5-dimensional 5-level (EQ-5d-5L) index score, which measures health-related quality of life and ranges from 0 (death) to 1 (full health).
Outcome measures
| Measure |
Arm I (Chemotherapy, Radiation Therapy)
n=174 Participants
Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)
n=180 Participants
Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
|---|---|---|
|
Quality-adjusted Survival Months
|
16.9 months
Interval 16.1 to 17.7
|
17.3 months
Interval 16.6 to 18.0
|
SECONDARY outcome
Timeframe: Baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization)Population: Intent-to-treat participants with score at baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization).
The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased fatigue.
Outcome measures
| Measure |
Arm I (Chemotherapy, Radiation Therapy)
n=102 Participants
Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)
n=111 Participants
Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
|---|---|---|
|
Change From Baseline in the 7 Item Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score
|
-2.0 score on a scale
Standard Deviation 9.9
|
-1.9 score on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Up to 5 yearsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 15 months after completion of chemoradiation therapyWill be measured by Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE). For each symptom and each domain (i.e., frequency, severity, and interference), counts and frequencies will be summarized for the worst score experienced by the patient by treatment arm.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsThe concordance between molecular subtypes obtained via ribonucleic acid sequencing (RNAseq) on tumor tissue and methylation analysis on cfDNA will be assessed among patients who have both evaluable RNAseq and methylation results, where Cohen's Kappa and corresponding 95% confidence interval will be reported. In addition, the sensitivity and specificity of dichotomized cfDNA molecular subtypes (considering RNAseq as reference standard), along with the associated 95% confidence intervals, will be reported. Spearman rank correlation and associated 95% confidence intervals based on bootstrap between RNAseq and methylation will be reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsEstimates of the primary outcome treatment effect and the corresponding 95% confidence intervals by sex will be provided.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsEstimates of the primary outcome treatment effect and the corresponding 95% CIs by race will be provided.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsEstimates of the primary outcome treatment effect and the corresponding 95% CIs by ethnicity will be provided.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Chemotherapy, Radiation Therapy)
Serious events: 106 serious events
Other events: 253 other events
Deaths: 120 deaths
Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)
Serious events: 159 serious events
Other events: 263 other events
Deaths: 132 deaths
Serious adverse events
| Measure |
Arm I (Chemotherapy, Radiation Therapy)
n=257 participants at risk
Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)
n=264 participants at risk
Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.7%
12/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
6.4%
17/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
0.78%
2/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.6%
17/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
13.3%
35/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.76%
2/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.78%
2/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
2.3%
6/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Cardiac disorders
Cardiac arrest
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.5%
4/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Cardiac disorders
Cardiac disorders - Other
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Cardiac disorders
Chest pain - cardiac
|
1.6%
4/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.76%
2/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Cardiac disorders
Heart failure
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
2.7%
7/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Cardiac disorders
Myocardial infarction
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
2.7%
7/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Cardiac disorders
Palpitations
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.76%
2/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Cardiac disorders
Sinus bradycardia
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.76%
2/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.76%
2/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Constipation
|
0.78%
2/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.1%
3/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Diarrhea
|
1.2%
3/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
2.7%
7/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Dysphagia
|
1.6%
4/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.76%
2/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.76%
2/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Esophagitis
|
3.9%
10/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
5.7%
15/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
6/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
3.4%
9/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
3/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
4.2%
11/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
General disorders
Death NOS
|
0.78%
2/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.76%
2/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
General disorders
Disease progression
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.5%
4/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
General disorders
Fatigue
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.9%
5/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
General disorders
Fever
|
0.78%
2/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.9%
5/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
General disorders
Flu like symptoms
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
General disorders
Gait disturbance
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
General disorders
Multi-organ failure
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
General disorders
Non-cardiac chest pain
|
0.78%
2/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
2.7%
7/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
General disorders
Pain
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
General disorders
Sudden death NOS
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.76%
2/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Immune system disorders
Allergic reaction
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Bone infection
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Device related infection
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Encephalitis infection
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Enterocolitis infectious
|
0.78%
2/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.5%
4/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Infections and infestations - Other
|
1.6%
4/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
3.4%
9/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Lung infection
|
3.5%
9/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
7.2%
19/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Meningitis
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Sepsis
|
3.1%
8/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
3.8%
10/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Skin infection
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.5%
4/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Thrush
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Upper respiratory infection
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Urinary tract infection
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.5%
4/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.1%
3/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.76%
2/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.5%
4/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Creatinine increased
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.1%
3/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
INR increased
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Investigations - Other
|
0.78%
2/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Lymphocyte count decreased
|
1.9%
5/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.5%
4/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Neutrophil count decreased
|
10.9%
28/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
10.2%
27/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Platelet count decreased
|
7.0%
18/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
4.2%
11/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Weight loss
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
White blood cell decreased
|
10.1%
26/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
6.8%
18/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.9%
5/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.9%
10/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
3.0%
8/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.78%
2/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.2%
3/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.2%
3/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.6%
4/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
4.9%
13/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.9%
5/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.5%
4/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Headache
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Presyncope
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Seizure
|
0.78%
2/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Somnolence
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Spinal cord compression
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Stroke
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.9%
5/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Syncope
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.5%
4/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.76%
2/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.78%
2/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
2.3%
6/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Renal and urinary disorders
Renal calculi
|
0.78%
2/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.76%
2/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.00%
0/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.76%
2/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.3%
6/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
3.4%
9/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
4.5%
12/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.78%
2/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.5%
9/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
9.1%
24/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.76%
2/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
3/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
4.2%
11/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.78%
2/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.9%
5/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
1.1%
3/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Vascular disorders
Arterial thromboembolism
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.76%
2/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Vascular disorders
Hypertension
|
0.78%
2/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.38%
1/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Vascular disorders
Hypotension
|
0.78%
2/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
4.5%
12/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Vascular disorders
Peripheral ischemia
|
0.00%
0/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
0.76%
2/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Vascular disorders
Thromboembolic event
|
2.7%
7/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
4.5%
12/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
Other adverse events
| Measure |
Arm I (Chemotherapy, Radiation Therapy)
n=257 participants at risk
Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)
n=264 participants at risk
Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
81.7%
210/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
83.3%
220/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.0%
18/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
3.0%
8/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Cardiac disorders
Palpitations
|
4.7%
12/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
9.1%
24/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Cardiac disorders
Sinus tachycardia
|
13.6%
35/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
15.5%
41/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
43/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
9.8%
26/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Endocrine disorders
Hyperthyroidism
|
0.39%
1/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
13.6%
36/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Endocrine disorders
Hypothyroidism
|
3.1%
8/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
18.6%
49/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Eye disorders
Blurred vision
|
12.8%
33/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
15.5%
41/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.9%
28/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
13.3%
35/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Constipation
|
39.7%
102/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
46.6%
123/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Diarrhea
|
23.0%
59/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
38.3%
101/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Dry mouth
|
4.7%
12/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
7.2%
19/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.3%
24/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
10.2%
27/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Dysphagia
|
38.1%
98/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
32.6%
86/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Esophageal pain
|
6.6%
17/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
6.4%
17/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Esophagitis
|
57.2%
147/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
59.8%
158/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.9%
28/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
15.5%
41/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
3.1%
8/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
7.2%
19/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Mucositis oral
|
9.3%
24/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
12.1%
32/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Nausea
|
54.1%
139/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
62.5%
165/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Gastrointestinal disorders
Vomiting
|
26.5%
68/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
27.3%
72/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
General disorders
Chills
|
7.4%
19/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
9.5%
25/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
General disorders
Edema limbs
|
13.2%
34/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
16.3%
43/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
General disorders
Fatigue
|
70.8%
182/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
75.8%
200/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
General disorders
Fever
|
8.2%
21/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
10.2%
27/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
General disorders
Malaise
|
5.1%
13/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
7.6%
20/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
General disorders
Non-cardiac chest pain
|
10.9%
28/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
15.2%
40/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
General disorders
Pain
|
11.3%
29/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
15.5%
41/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Infections and infestations - Other
|
4.7%
12/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
10.2%
27/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Lung infection
|
5.4%
14/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
10.2%
27/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Thrush
|
6.2%
16/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
9.1%
24/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Upper respiratory infection
|
1.9%
5/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
5.3%
14/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Infections and infestations
Urinary tract infection
|
7.0%
18/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
4.5%
12/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Injury, poisoning and procedural complications
Bruising
|
3.1%
8/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
5.3%
14/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
18.7%
48/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
23.9%
63/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Injury, poisoning and procedural complications
Fall
|
5.8%
15/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
7.6%
20/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.1%
8/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
5.7%
15/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Alanine aminotransferase increased
|
9.7%
25/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
16.7%
44/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Alkaline phosphatase increased
|
11.3%
29/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
22.3%
59/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Aspartate aminotransferase increased
|
9.7%
25/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
15.9%
42/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Blood bilirubin increased
|
4.3%
11/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
6.1%
16/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Creatinine increased
|
17.5%
45/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
22.3%
59/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Investigations - Other
|
3.5%
9/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
6.1%
16/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Lymphocyte count decreased
|
63.4%
163/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
65.2%
172/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Neutrophil count decreased
|
85.6%
220/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
85.6%
226/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Platelet count decreased
|
73.5%
189/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
80.3%
212/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Thyroid stimulating hormone increased
|
2.7%
7/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
5.7%
15/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
Weight loss
|
19.8%
51/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
32.6%
86/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Investigations
White blood cell decreased
|
81.3%
209/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
84.1%
222/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Metabolism and nutrition disorders
Anorexia
|
34.6%
89/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
48.1%
127/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Metabolism and nutrition disorders
Dehydration
|
18.3%
47/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
22.0%
58/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.5%
9/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
5.3%
14/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
31.1%
80/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
29.9%
79/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.2%
16/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
11.4%
30/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
22.6%
58/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
29.9%
79/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.8%
38/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
22.0%
58/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
27.6%
71/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
36.0%
95/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
23.3%
60/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
26.9%
71/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.1%
85/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
38.6%
102/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
13/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
9.8%
26/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.6%
35/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
20.5%
54/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.9%
10/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
5.3%
14/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
13.2%
34/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
9.8%
26/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
2.7%
7/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
6.8%
18/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.0%
18/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
8.7%
23/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.6%
22/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
6.8%
18/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Dizziness
|
31.1%
80/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
36.7%
97/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Dysgeusia
|
14.8%
38/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
25.0%
66/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Headache
|
22.2%
57/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
32.2%
85/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Memory impairment
|
7.4%
19/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
12.5%
33/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Paresthesia
|
3.5%
9/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
5.7%
15/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.2%
39/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
18.9%
50/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Nervous system disorders
Tremor
|
1.2%
3/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
6.1%
16/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Psychiatric disorders
Anxiety
|
6.6%
17/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
12.1%
32/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Psychiatric disorders
Depression
|
7.0%
18/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
10.6%
28/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Psychiatric disorders
Insomnia
|
20.2%
52/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
27.3%
72/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
38.9%
100/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
45.5%
120/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.9%
105/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
53.4%
141/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
5/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
5.3%
14/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.9%
10/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
5.3%
14/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.3%
11/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
6.1%
16/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.6%
4/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
5.3%
14/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.3%
24/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
21.6%
57/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.3%
29/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
15.5%
41/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
3.5%
9/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
7.2%
19/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
1.2%
3/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
6.1%
16/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
13.2%
34/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
10.2%
27/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.1%
8/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
8.0%
21/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
31.1%
80/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
28.4%
75/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.9%
10/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
9.8%
26/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.9%
28/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
22.3%
59/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.3%
6/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
6.1%
16/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.2%
21/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
19.3%
51/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
2.7%
7/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
9.8%
26/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Vascular disorders
Hypertension
|
20.6%
53/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
15.5%
41/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Vascular disorders
Hypotension
|
10.9%
28/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
16.3%
43/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
|
Vascular disorders
Thromboembolic event
|
7.4%
19/257 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
8.0%
21/264 • Baseline to the date of last known follow-up. Median follow-up was 23.8 months.
All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60