Trial Outcomes & Findings for Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma (NCT NCT02179086)
NCT ID: NCT02179086
Last Updated: 2026-08-28
Results Overview
Comparisons occur between standard vs. intensified RT arms within group (Group 1: photon IMRT centers; Group 2: proton centers). Median survival times were estimated using the Kaplan-Meier method, censoring participants alive at the time of analysis. Comparisons occur between standard vs. intensified RT arms within group (Group 1: photon IMRT centers; Group 2: proton centers)
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
624 participants
Primary outcome timeframe
Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
Results posted on
2026-08-28
Participant Flow
Central pathology review screening was required for confirmation of histology and adequacy of tissue for MGMT analysis. Of 624 screened patients, 431 were randomized.
Participant milestones
| Measure |
Group 1 - Standard RT (Photon) (Arm A1)
Group 1 = Photon IMRT centers. Participants undergo standard-dose postoperative photon radiotherapy using 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) administered once daily, 5 days per week. Treatment consists of 46 Gy in 23 fractions followed by a sequential boost to a total dose of 60 Gy in 30 fractions. Participants receive concurrent temozolomide orally once daily during radiotherapy for up to 49 days and adjuvant temozolomide orally once daily on days 1-5 of each 28-day cycle for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
Group 1 - Intensified RT (Photon) (Arm B)
Group 1 = Photon IMRT centers. Participants undergo postoperative photon IMRT administered once daily, 5 days per week for 30 fractions using a simultaneous integrated boost technique. The elective target volume receives 50 Gy in 30 fractions, and the boost target volume receives 75 Gy in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Standard RT (Proton) (Arm A2)
Group 2 = Proton centers. Participants undergo the same standard-dose postoperative radiotherapy regimen described for Arm A1 but delivered using proton beam therapy. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Intensified RT (Proton) (Arm C)
Group 2 = Proton centers. Patients undergo dose-escalated and -intensified proton beam therapy QD, 5 days a week for a total of 30 fractions.
In all treatment arms, patients receive temozolomide PO QD while receiving radiation, for up to 49 days. Then beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
94
|
144
|
77
|
116
|
|
Overall Study
COMPLETED
|
94
|
144
|
77
|
116
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
Baseline characteristics by cohort
| Measure |
Group 1 - Standard RT (Proton) (Arm A1)
n=94 Participants
Group 2 = Proton centers. Participants undergo the same standard-dose postoperative radiotherapy regimen described for Arm A1 but delivered using proton beam therapy. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 1 - Intensified RT (Photon) (Arm B)
n=144 Participants
Group 1 = Photon IMRT centers. Participants undergo postoperative photon IMRT administered once daily, 5 days per week for 30 fractions using a simultaneous integrated boost technique. The elective target volume receives 50 Gy in 30 fractions, and the boost target volume receives 75 Gy in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Standard RT (Photon) (Arm A2)
n=77 Participants
Group 2 = Proton centers. Patients undergo standard-dose photon irradiation using 3D-CRT or IMRT as in Arm A1.
In all treatment arms, patients receive temozolomide PO QD while receiving radiation, for up to 49 days. Then beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
Group 2 - Intensified RT (Proton) (Arm C)
n=116 Participants
Group 2 = Proton centers. Patients undergo dose-escalated and -intensified proton beam therapy QD, 5 days a week for a total of 30 fractions.
In all treatment arms, patients receive temozolomide PO QD while receiving radiation, for up to 49 days. Then beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
Total
n=431 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.5 years
n=31 Participants
|
62 years
n=49 Participants
|
60 years
n=80 Participants
|
59 years
n=29 Participants
|
60 years
n=106 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=31 Participants
|
50 Participants
n=49 Participants
|
30 Participants
n=80 Participants
|
45 Participants
n=29 Participants
|
164 Participants
n=106 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=31 Participants
|
94 Participants
n=49 Participants
|
47 Participants
n=80 Participants
|
71 Participants
n=29 Participants
|
267 Participants
n=106 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
2 Participants
n=106 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
1 Participants
n=29 Participants
|
6 Participants
n=106 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=31 Participants
|
4 Participants
n=49 Participants
|
2 Participants
n=80 Participants
|
6 Participants
n=29 Participants
|
17 Participants
n=106 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=31 Participants
|
132 Participants
n=49 Participants
|
68 Participants
n=80 Participants
|
100 Participants
n=29 Participants
|
381 Participants
n=106 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
2 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
2 Participants
n=106 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=31 Participants
|
6 Participants
n=49 Participants
|
4 Participants
n=80 Participants
|
9 Participants
n=29 Participants
|
23 Participants
n=106 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=31 Participants
|
16 Participants
n=49 Participants
|
8 Participants
n=80 Participants
|
10 Participants
n=29 Participants
|
43 Participants
n=106 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=31 Participants
|
126 Participants
n=49 Participants
|
64 Participants
n=80 Participants
|
98 Participants
n=29 Participants
|
370 Participants
n=106 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
5 Participants
n=80 Participants
|
8 Participants
n=29 Participants
|
18 Participants
n=106 Participants
|
|
Karnofsky performance status
70
|
12 Participants
n=31 Participants
|
21 Participants
n=49 Participants
|
7 Participants
n=80 Participants
|
13 Participants
n=29 Participants
|
53 Participants
n=106 Participants
|
|
Karnofsky performance status
80
|
23 Participants
n=31 Participants
|
35 Participants
n=49 Participants
|
14 Participants
n=80 Participants
|
24 Participants
n=29 Participants
|
96 Participants
n=106 Participants
|
|
Karnofsky performance status
90
|
47 Participants
n=31 Participants
|
62 Participants
n=49 Participants
|
44 Participants
n=80 Participants
|
61 Participants
n=29 Participants
|
214 Participants
n=106 Participants
|
|
Karnofsky performance status
100
|
12 Participants
n=31 Participants
|
26 Participants
n=49 Participants
|
12 Participants
n=80 Participants
|
18 Participants
n=29 Participants
|
68 Participants
n=106 Participants
|
|
Surgical Resection Type
Partial debulking
|
19 Participants
n=31 Participants
|
26 Participants
n=49 Participants
|
13 Participants
n=80 Participants
|
31 Participants
n=29 Participants
|
89 Participants
n=106 Participants
|
|
Surgical Resection Type
Gross total resection
|
75 Participants
n=31 Participants
|
118 Participants
n=49 Participants
|
64 Participants
n=80 Participants
|
85 Participants
n=29 Participants
|
342 Participants
n=106 Participants
|
|
Neurologic Function
No Symptoms
|
23 Participants
n=31 Participants
|
53 Participants
n=49 Participants
|
25 Participants
n=80 Participants
|
35 Participants
n=29 Participants
|
136 Participants
n=106 Participants
|
|
Neurologic Function
Minor Symptoms
|
61 Participants
n=31 Participants
|
75 Participants
n=49 Participants
|
39 Participants
n=80 Participants
|
63 Participants
n=29 Participants
|
238 Participants
n=106 Participants
|
|
Neurologic Function
Moderate symptoms (fully active)
|
6 Participants
n=31 Participants
|
13 Participants
n=49 Participants
|
11 Participants
n=80 Participants
|
15 Participants
n=29 Participants
|
45 Participants
n=106 Participants
|
|
Neurologic Function
Moderate symptoms (required assistance)
|
4 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
2 Participants
n=80 Participants
|
3 Participants
n=29 Participants
|
12 Participants
n=106 Participants
|
|
MGMT Status
Methylated
|
30 Participants
n=31 Participants
|
50 Participants
n=49 Participants
|
29 Participants
n=80 Participants
|
44 Participants
n=29 Participants
|
153 Participants
n=106 Participants
|
|
MGMT Status
Unmethylated
|
54 Participants
n=31 Participants
|
84 Participants
n=49 Participants
|
40 Participants
n=80 Participants
|
68 Participants
n=29 Participants
|
246 Participants
n=106 Participants
|
|
MGMT Status
Indeterminate
|
10 Participants
n=31 Participants
|
10 Participants
n=49 Participants
|
8 Participants
n=80 Participants
|
4 Participants
n=29 Participants
|
32 Participants
n=106 Participants
|
|
Recursive Partitioning Analysis (RPA) Classification
III
|
15 Participants
n=31 Participants
|
21 Participants
n=49 Participants
|
12 Participants
n=80 Participants
|
16 Participants
n=29 Participants
|
64 Participants
n=106 Participants
|
|
Recursive Partitioning Analysis (RPA) Classification
IV
|
71 Participants
n=31 Participants
|
109 Participants
n=49 Participants
|
54 Participants
n=80 Participants
|
83 Participants
n=29 Participants
|
317 Participants
n=106 Participants
|
|
Recursive Partitioning Analysis (RPA) Classification
V
|
8 Participants
n=31 Participants
|
14 Participants
n=49 Participants
|
11 Participants
n=80 Participants
|
17 Participants
n=29 Participants
|
50 Participants
n=106 Participants
|
PRIMARY outcome
Timeframe: Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.Population: Randomized participants.
Comparisons occur between standard vs. intensified RT arms within group (Group 1: photon IMRT centers; Group 2: proton centers). Median survival times were estimated using the Kaplan-Meier method, censoring participants alive at the time of analysis. Comparisons occur between standard vs. intensified RT arms within group (Group 1: photon IMRT centers; Group 2: proton centers)
Outcome measures
| Measure |
Group 1 - Standard RT (Photon) (Arm A1)
n=94 Participants
Group 1 = Photon IMRT centers. Participants undergo standard-dose postoperative photon radiotherapy using 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) administered once daily, 5 days per week. Treatment consists of 46 Gy in 23 fractions followed by a sequential boost to a total dose of 60 Gy in 30 fractions. Participants receive concurrent temozolomide orally once daily during radiotherapy for up to 49 days and adjuvant temozolomide orally once daily on days 1-5 of each 28-day cycle for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
Group 1 - Intensified RT (Photon) (Arm B)
n=144 Participants
Group 1 = Photon IMRT centers. Participants undergo postoperative photon IMRT administered once daily, 5 days per week for 30 fractions using a simultaneous integrated boost technique. The elective target volume receives 50 Gy in 30 fractions, and the boost target volume receives 75 Gy in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Standard RT (Proton) (Arm A2)
n=77 Participants
Group 2 = Proton centers. Participants undergo the same standard-dose postoperative radiotherapy regimen described for Arm A1 but delivered using proton beam therapy. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Intensified RT (Proton) (Arm C)
n=116 Participants
Group 2 = Proton centers. Participants undergo the same radiotherapy regimen described for Arm B but delivered using proton beam therapy. The elective target volume receives 50 Gy(RBE) in 30 fractions, and the boost target volume receives 75 Gy(RBE) in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
|---|---|---|---|---|
|
Median Survival Time (Within Center Group)
|
16.3 months
Interval 14.0 to 20.5
|
18.8 months
Interval 16.0 to 23.9
|
22.0 months
Interval 15.8 to 27.8
|
22.8 months
Interval 20.0 to 28.6
|
SECONDARY outcome
Timeframe: Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.Population: No participants were included in the analysis population because the protocol-specified condition for this outcome was not met.
Per the protocol, this outcome measure would be addressed only if both experimental (intensified RT) arms were statistically significantly different from their respective control (standard RT) arms, as defined in the primary outcome measure. If that condition were satisfied, the experimental (intensified RT) arms from each group would be compared with each other. Median survival times would be estimated using the Kaplan-Meier method, censoring participants alive at the time of analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to progression, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.Population: Randomized participants.
Progression is defined as any of the following: ≥25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration, with the treating institution encouraged to differentiate progression from pseudoprogression and radionecrosis using surgical resection, biopsy, and alternative imaging accordingly. Median progression-free survival times were estimated using the Kaplan-Meier method, censoring participants alive at the time of analysis. Comparisons occur between standard vs. intensified RT arms within group (Group 1: photon IMRT centers; Group 2: proton centers).
Outcome measures
| Measure |
Group 1 - Standard RT (Photon) (Arm A1)
n=94 Participants
Group 1 = Photon IMRT centers. Participants undergo standard-dose postoperative photon radiotherapy using 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) administered once daily, 5 days per week. Treatment consists of 46 Gy in 23 fractions followed by a sequential boost to a total dose of 60 Gy in 30 fractions. Participants receive concurrent temozolomide orally once daily during radiotherapy for up to 49 days and adjuvant temozolomide orally once daily on days 1-5 of each 28-day cycle for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
Group 1 - Intensified RT (Photon) (Arm B)
n=144 Participants
Group 1 = Photon IMRT centers. Participants undergo postoperative photon IMRT administered once daily, 5 days per week for 30 fractions using a simultaneous integrated boost technique. The elective target volume receives 50 Gy in 30 fractions, and the boost target volume receives 75 Gy in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Standard RT (Proton) (Arm A2)
n=77 Participants
Group 2 = Proton centers. Participants undergo the same standard-dose postoperative radiotherapy regimen described for Arm A1 but delivered using proton beam therapy. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Intensified RT (Proton) (Arm C)
n=116 Participants
Group 2 = Proton centers. Participants undergo the same radiotherapy regimen described for Arm B but delivered using proton beam therapy. The elective target volume receives 50 Gy(RBE) in 30 fractions, and the boost target volume receives 75 Gy(RBE) in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
|---|---|---|---|---|
|
Median Progression-free Survival Time
|
6.3 months
Interval 5.2 to 8.8
|
6.5 months
Interval 5.3 to 7.9
|
8.3 months
Interval 5.5 to 14.3
|
8.8 months
Interval 7.9 to 11.1
|
SECONDARY outcome
Timeframe: Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.Population: Randomized participants who started protocol treatment.
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Proportions were estimated using an exact binomial distribution. Comparisons occur between standard vs. intensified RT arms within group (Group 1: photon IMRT centers; Group 2: proton centers)
Outcome measures
| Measure |
Group 1 - Standard RT (Photon) (Arm A1)
n=88 Participants
Group 1 = Photon IMRT centers. Participants undergo standard-dose postoperative photon radiotherapy using 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) administered once daily, 5 days per week. Treatment consists of 46 Gy in 23 fractions followed by a sequential boost to a total dose of 60 Gy in 30 fractions. Participants receive concurrent temozolomide orally once daily during radiotherapy for up to 49 days and adjuvant temozolomide orally once daily on days 1-5 of each 28-day cycle for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
Group 1 - Intensified RT (Photon) (Arm B)
n=140 Participants
Group 1 = Photon IMRT centers. Participants undergo postoperative photon IMRT administered once daily, 5 days per week for 30 fractions using a simultaneous integrated boost technique. The elective target volume receives 50 Gy in 30 fractions, and the boost target volume receives 75 Gy in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Standard RT (Proton) (Arm A2)
n=60 Participants
Group 2 = Proton centers. Participants undergo the same standard-dose postoperative radiotherapy regimen described for Arm A1 but delivered using proton beam therapy. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Intensified RT (Proton) (Arm C)
n=111 Participants
Group 2 = Proton centers. Participants undergo the same radiotherapy regimen described for Arm B but delivered using proton beam therapy. The elective target volume receives 50 Gy(RBE) in 30 fractions, and the boost target volume receives 75 Gy(RBE) in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
|---|---|---|---|---|
|
Proportion of Participants With a Grade 3 or Higher Adverse Event
|
0.580 proportion of participants
Interval 0.47 to 0.68
|
0.686 proportion of participants
Interval 0.6 to 0.76
|
0.567 proportion of participants
Interval 0.43 to 0.69
|
0.649 proportion of participants
Interval 0.55 to 0.74
|
SECONDARY outcome
Timeframe: Baseline and end of cycle 3 of adjuvant temozolomide (approximately 24 weeks after start of chemoradiation)Population: Randomized participants who consented to the net clinical benefit component and were progression-free with available data at the specified time point.
The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Cognitive Factor) is the average of the subscale items, given that a specified minimum numbers of items were completed. A score worse than baseline by at least one is considered deterioration. Change is calculated as time point - baseline such that a positive change value indicates worse symptoms compared to baseline. Comparisons occur between standard vs. intensified RT arms within group (Group 1: photon IMRT centers; Group 2: proton centers).
Outcome measures
| Measure |
Group 1 - Standard RT (Photon) (Arm A1)
n=25 Participants
Group 1 = Photon IMRT centers. Participants undergo standard-dose postoperative photon radiotherapy using 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) administered once daily, 5 days per week. Treatment consists of 46 Gy in 23 fractions followed by a sequential boost to a total dose of 60 Gy in 30 fractions. Participants receive concurrent temozolomide orally once daily during radiotherapy for up to 49 days and adjuvant temozolomide orally once daily on days 1-5 of each 28-day cycle for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
Group 1 - Intensified RT (Photon) (Arm B)
n=48 Participants
Group 1 = Photon IMRT centers. Participants undergo postoperative photon IMRT administered once daily, 5 days per week for 30 fractions using a simultaneous integrated boost technique. The elective target volume receives 50 Gy in 30 fractions, and the boost target volume receives 75 Gy in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Standard RT (Proton) (Arm A2)
n=18 Participants
Group 2 = Proton centers. Participants undergo the same standard-dose postoperative radiotherapy regimen described for Arm A1 but delivered using proton beam therapy. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Intensified RT (Proton) (Arm C)
n=43 Participants
Group 2 = Proton centers. Participants undergo the same radiotherapy regimen described for Arm B but delivered using proton beam therapy. The elective target volume receives 50 Gy(RBE) in 30 fractions, and the boost target volume receives 75 Gy(RBE) in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
|---|---|---|---|---|
|
Change From Baseline in the M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Factor Score After Cycle 3
|
-0.28 score on a scale
Standard Deviation 1.22
|
0.41 score on a scale
Standard Deviation 1.73
|
-0.19 score on a scale
Standard Deviation 2.34
|
0.21 score on a scale
Standard Deviation 2.21
|
SECONDARY outcome
Timeframe: Baseline and end of cycle 12 of adjuvant temozolomide (approximately 60 weeks after start of chemoradiation)Population: Randomized participants who consented to the net clinical benefit component and were progression-free with available data at the specified time point.
The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Cognitive Factor) is the average of the subscale items, given that a specified minimum numbers of items were completed. A score worse than baseline by at least one is considered deterioration. Change is calculated as time point - baseline such that a positive change value indicates worse symptoms compared to baseline. Comparisons occur between standard vs. intensified RT arms within group (Group 1: photon IMRT centers; Group 2: proton centers).
Outcome measures
| Measure |
Group 1 - Standard RT (Photon) (Arm A1)
n=11 Participants
Group 1 = Photon IMRT centers. Participants undergo standard-dose postoperative photon radiotherapy using 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) administered once daily, 5 days per week. Treatment consists of 46 Gy in 23 fractions followed by a sequential boost to a total dose of 60 Gy in 30 fractions. Participants receive concurrent temozolomide orally once daily during radiotherapy for up to 49 days and adjuvant temozolomide orally once daily on days 1-5 of each 28-day cycle for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
Group 1 - Intensified RT (Photon) (Arm B)
n=11 Participants
Group 1 = Photon IMRT centers. Participants undergo postoperative photon IMRT administered once daily, 5 days per week for 30 fractions using a simultaneous integrated boost technique. The elective target volume receives 50 Gy in 30 fractions, and the boost target volume receives 75 Gy in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Standard RT (Proton) (Arm A2)
n=9 Participants
Group 2 = Proton centers. Participants undergo the same standard-dose postoperative radiotherapy regimen described for Arm A1 but delivered using proton beam therapy. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Intensified RT (Proton) (Arm C)
n=11 Participants
Group 2 = Proton centers. Participants undergo the same radiotherapy regimen described for Arm B but delivered using proton beam therapy. The elective target volume receives 50 Gy(RBE) in 30 fractions, and the boost target volume receives 75 Gy(RBE) in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
|---|---|---|---|---|
|
Change From Baseline in the M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Factor Score After Cycle 12
|
-0.27 score on a scale
Standard Deviation 1.93
|
0.75 score on a scale
Standard Deviation 1.88
|
0.69 score on a scale
Standard Deviation 3.67
|
0.87 score on a scale
Standard Deviation 2.44
|
SECONDARY outcome
Timeframe: Baseline and end of cycle 3 of adjuvant temozolomide (approximately 24 weeks after start of chemoradiation)Population: Randomized participants who consented to the net clinical benefit component and were progression-free with available data at the specified time point.
The Clinical Trial Battery Composite Standardized Score is calculated as the arithmetic mean of multiple standardized neurocognitive test scores assessing memory, processing speed, executive function, and verbal fluency. Scores are standardized (z-scores) adjusted for age, education, and gender, with a mean of 0 and standard deviation of 1. A participant must have the majority of component scores available to calculate the composite. Possible scores are standardized z-scores that typically range from approximately -3 to +3, with higher scores indicating a better outcome. Change is calculated as time point minus baseline such that a positive change value indicates improvement and a negative change value indicates decline. Comparisons are made between standard-dose and intensified radiation therapy arms within group (Group 1: photon IMRT centers; Group 2: proton centers).
Outcome measures
| Measure |
Group 1 - Standard RT (Photon) (Arm A1)
n=26 Participants
Group 1 = Photon IMRT centers. Participants undergo standard-dose postoperative photon radiotherapy using 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) administered once daily, 5 days per week. Treatment consists of 46 Gy in 23 fractions followed by a sequential boost to a total dose of 60 Gy in 30 fractions. Participants receive concurrent temozolomide orally once daily during radiotherapy for up to 49 days and adjuvant temozolomide orally once daily on days 1-5 of each 28-day cycle for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
Group 1 - Intensified RT (Photon) (Arm B)
n=49 Participants
Group 1 = Photon IMRT centers. Participants undergo postoperative photon IMRT administered once daily, 5 days per week for 30 fractions using a simultaneous integrated boost technique. The elective target volume receives 50 Gy in 30 fractions, and the boost target volume receives 75 Gy in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Standard RT (Proton) (Arm A2)
n=15 Participants
Group 2 = Proton centers. Participants undergo the same standard-dose postoperative radiotherapy regimen described for Arm A1 but delivered using proton beam therapy. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Intensified RT (Proton) (Arm C)
n=42 Participants
Group 2 = Proton centers. Participants undergo the same radiotherapy regimen described for Arm B but delivered using proton beam therapy. The elective target volume receives 50 Gy(RBE) in 30 fractions, and the boost target volume receives 75 Gy(RBE) in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
|---|---|---|---|---|
|
Change From Baseline in the Clinical Trial Battery Composite Standardized Score at End of Cycle 3
|
-0.28 Z-score
Standard Deviation 1.92
|
-0.46 Z-score
Standard Deviation 2.53
|
-0.78 Z-score
Standard Deviation 1.11
|
0.01 Z-score
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: Baseline and end of cycle 3 of adjuvant temozolomide (approximately 24 weeks after start of chemoradiation)Population: Randomized participants who consented to the net clinical benefit component and were progression-free with available data at the specified time point.
The Clinical Trial Battery Composite Standardized Score is calculated as the arithmetic mean of multiple standardized neurocognitive test scores assessing memory, processing speed, executive function, and verbal fluency. Scores are standardized (z-scores) adjusted for age, education, and gender, with a mean of 0 and standard deviation of 1. A participant must have the majority of component scores available to calculate the composite. Possible scores are standardized z-scores that typically range from approximately -3 to +3, with higher scores indicating a better outcome. Change is calculated as time point minus baseline such that a positive change value indicates improvement and a negative change value indicates decline. Comparisons are made between standard-dose and intensified radiation therapy arms within group (Group 1: photon IMRT centers; Group 2: proton centers).
Outcome measures
| Measure |
Group 1 - Standard RT (Photon) (Arm A1)
n=12 Participants
Group 1 = Photon IMRT centers. Participants undergo standard-dose postoperative photon radiotherapy using 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) administered once daily, 5 days per week. Treatment consists of 46 Gy in 23 fractions followed by a sequential boost to a total dose of 60 Gy in 30 fractions. Participants receive concurrent temozolomide orally once daily during radiotherapy for up to 49 days and adjuvant temozolomide orally once daily on days 1-5 of each 28-day cycle for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
Group 1 - Intensified RT (Photon) (Arm B)
n=10 Participants
Group 1 = Photon IMRT centers. Participants undergo postoperative photon IMRT administered once daily, 5 days per week for 30 fractions using a simultaneous integrated boost technique. The elective target volume receives 50 Gy in 30 fractions, and the boost target volume receives 75 Gy in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Standard RT (Proton) (Arm A2)
n=8 Participants
Group 2 = Proton centers. Participants undergo the same standard-dose postoperative radiotherapy regimen described for Arm A1 but delivered using proton beam therapy. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Intensified RT (Proton) (Arm C)
n=10 Participants
Group 2 = Proton centers. Participants undergo the same radiotherapy regimen described for Arm B but delivered using proton beam therapy. The elective target volume receives 50 Gy(RBE) in 30 fractions, and the boost target volume receives 75 Gy(RBE) in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
|---|---|---|---|---|
|
Change From Baseline in the Clinical Trial Battery Composite Standardized Score at End of Cycle 12
|
0.55 Score on a scale
Standard Deviation 1.58
|
0.63 Score on a scale
Standard Deviation 1.66
|
-0.60 Score on a scale
Standard Deviation 2.42
|
-1.59 Score on a scale
Standard Deviation 4.36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 5 yearsMean CD4 lymphopenia count change from baseline to each follow-up collection timepoint.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline - cycle 4Will be determined retrospectively following central review by an experienced neuro-radiologist blinded to the patient's outcome.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 12 monthsCox proportional hazard model will be used to analyze the effect of imaging markers on overall survival. Known prognostic factors and patient baseline characteristics will be included in the multivariate analyses as covariates.
Outcome measures
Outcome data not reported
Adverse Events
Group 1 - Standard RT (Photon) (Arm A1)
Serious events: 31 serious events
Other events: 83 other events
Deaths: 80 deaths
Group 1 - Intensified RT (Photon) (Arm B)
Serious events: 63 serious events
Other events: 133 other events
Deaths: 122 deaths
Group 2 - Standard RT (Proton) (Arm A2)
Serious events: 15 serious events
Other events: 60 other events
Deaths: 46 deaths
Group 2 - Intensified RT (Proton) (Arm C)
Serious events: 39 serious events
Other events: 110 other events
Deaths: 90 deaths
Serious adverse events
| Measure |
Group 1 - Standard RT (Photon) (Arm A1)
n=88 participants at risk
Group 1 = Photon IMRT centers. Participants undergo standard-dose postoperative photon radiotherapy using 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) administered once daily, 5 days per week. Treatment consists of 46 Gy in 23 fractions followed by a sequential boost to a total dose of 60 Gy in 30 fractions. Participants receive concurrent temozolomide orally once daily during radiotherapy for up to 49 days and adjuvant temozolomide orally once daily on days 1-5 of each 28-day cycle for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
Group 1 - Intensified RT (Photon) (Arm B)
n=140 participants at risk
Group 1 = Photon IMRT centers. Participants undergo postoperative photon IMRT administered once daily, 5 days per week for 30 fractions using a simultaneous integrated boost technique. The elective target volume receives 50 Gy in 30 fractions, and the boost target volume receives 75 Gy in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Standard RT (Proton) (Arm A2)
n=60 participants at risk
Group 2 = Proton centers. Participants undergo the same standard-dose postoperative radiotherapy regimen described for Arm A1 but delivered using proton beam therapy. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Intensified RT (Proton) (Arm C)
n=111 participants at risk
Group 2 = Proton centers. Group 2 = Proton centers. Participants undergo the same radiotherapy regimen described for Arm B but delivered using proton beam therapy. The elective target volume receives 50 Gy(RBE) in 30 fractions, and the boost target volume receives 75 Gy(RBE) in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.4%
2/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Eye disorders
Blurred vision
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.8%
2/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.4%
2/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.4%
2/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.8%
2/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
Chills
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
Death NOS
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
Edema limbs
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
Fatigue
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.4%
2/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
Fever
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
Gait disturbance
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.4%
2/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
General disorders and administration site conditions - Other
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
Localized edema
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
Sudden death NOS
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Immune system disorders
Allergic reaction
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Infections and infestations
Bone infection
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Infections and infestations
Bronchial infection
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Infections and infestations
Infections and infestations - Other
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.4%
2/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Infections and infestations
Lung infection
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
2.9%
4/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Infections and infestations
Sepsis
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
2.1%
3/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Infections and infestations
Skin infection
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
2.7%
3/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.4%
2/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
2.7%
3/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.4%
2/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Investigations - Other
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Lymphocyte count decreased
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Neutrophil count decreased
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
2.9%
4/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.8%
2/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Platelet count decreased
|
6.8%
6/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.6%
5/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.6%
4/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
White blood cell decreased
|
5.7%
5/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.6%
5/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
2.1%
3/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.4%
3/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.4%
2/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.6%
4/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.4%
2/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.6%
5/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Head soft tissue necrosis
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.4%
2/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
4.5%
4/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.6%
5/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Ataxia
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Central nervous system necrosis
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.7%
8/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.1%
9/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Cognitive disturbance
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.4%
2/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.8%
2/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Dysarthria
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Dysphasia
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Edema cerebral
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Encephalopathy
|
3.4%
3/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.6%
5/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Headache
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
2.1%
3/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.8%
2/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Hydrocephalus
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.4%
2/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.4%
2/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Seizure
|
6.8%
6/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
12.9%
18/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.0%
6/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.8%
12/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Stroke
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Syncope
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.4%
2/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Psychiatric disorders
Confusion
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
2.1%
3/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
4.5%
5/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Psychiatric disorders
Psychosis
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Vascular disorders
Hematoma
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.4%
2/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Vascular disorders
Thromboembolic event
|
4.5%
4/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.7%
8/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.4%
6/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
Other adverse events
| Measure |
Group 1 - Standard RT (Photon) (Arm A1)
n=88 participants at risk
Group 1 = Photon IMRT centers. Participants undergo standard-dose postoperative photon radiotherapy using 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) administered once daily, 5 days per week. Treatment consists of 46 Gy in 23 fractions followed by a sequential boost to a total dose of 60 Gy in 30 fractions. Participants receive concurrent temozolomide orally once daily during radiotherapy for up to 49 days and adjuvant temozolomide orally once daily on days 1-5 of each 28-day cycle for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
Group 1 - Intensified RT (Photon) (Arm B)
n=140 participants at risk
Group 1 = Photon IMRT centers. Participants undergo postoperative photon IMRT administered once daily, 5 days per week for 30 fractions using a simultaneous integrated boost technique. The elective target volume receives 50 Gy in 30 fractions, and the boost target volume receives 75 Gy in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Standard RT (Proton) (Arm A2)
n=60 participants at risk
Group 2 = Proton centers. Participants undergo the same standard-dose postoperative radiotherapy regimen described for Arm A1 but delivered using proton beam therapy. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
Group 2 - Intensified RT (Proton) (Arm C)
n=111 participants at risk
Group 2 = Proton centers. Group 2 = Proton centers. Participants undergo the same radiotherapy regimen described for Arm B but delivered using proton beam therapy. The elective target volume receives 50 Gy(RBE) in 30 fractions, and the boost target volume receives 75 Gy(RBE) in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
29.5%
26/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
30.7%
43/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
21.7%
13/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
31.5%
35/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.71%
1/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.8%
2/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
3.4%
3/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
2.1%
3/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.7%
4/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.8%
2/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
4.5%
4/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.6%
5/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.3%
2/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.4%
6/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Ear and labyrinth disorders
Hearing impaired
|
8.0%
7/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.7%
15/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.3%
2/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
9.9%
11/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.7%
5/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.6%
12/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.3%
2/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.3%
7/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Eye disorders
Blurred vision
|
17.0%
15/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
12.9%
18/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
16.7%
10/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
29.7%
33/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Eye disorders
Eye disorders - Other
|
4.5%
4/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.6%
12/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.3%
5/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
14.4%
16/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
5/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.4%
9/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
4.5%
5/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Constipation
|
40.9%
36/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
40.0%
56/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
45.0%
27/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
35.1%
39/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
13.6%
12/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
12.9%
18/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
20.0%
12/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
18.9%
21/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.8%
6/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.6%
12/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.7%
4/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.4%
6/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
5.7%
5/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.6%
12/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.0%
6/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
12.6%
14/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
7/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
9.1%
8/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.6%
5/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
4.5%
4/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.6%
5/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.7%
4/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.3%
7/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Nausea
|
53.4%
47/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
49.3%
69/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
51.7%
31/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
56.8%
63/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Vomiting
|
19.3%
17/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
16.4%
23/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
23.3%
14/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
20.7%
23/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
Chills
|
4.5%
4/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
7/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.7%
4/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
4.5%
5/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
Edema face
|
4.5%
4/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.7%
8/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.3%
7/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
Edema limbs
|
11.4%
10/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
13.6%
19/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.3%
5/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
18.0%
20/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
Fatigue
|
80.7%
71/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
79.3%
111/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
86.7%
52/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
90.1%
100/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
Gait disturbance
|
9.1%
8/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
18.6%
26/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
18.3%
11/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
27.9%
31/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
General disorders and administration site conditions - Other
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
2.9%
4/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
4.5%
5/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
Irritability
|
4.5%
4/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
4.3%
6/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.7%
4/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
9.0%
10/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
Localized edema
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
4.3%
6/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.4%
6/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
4.5%
4/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
2.9%
4/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
2.7%
3/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders and administration site conditions
Pain
|
5.7%
5/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
7.9%
11/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
16.7%
10/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.1%
9/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Infections and infestations
Infections and infestations - Other
|
8.0%
7/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
4.3%
6/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.0%
6/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.1%
9/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Infections and infestations
Skin infection
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.7%
8/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.8%
2/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Infections and infestations
Upper respiratory infection
|
6.8%
6/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
7/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.3%
2/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.3%
7/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Infections and infestations
Urinary tract infection
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.7%
8/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.3%
7/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
2.9%
4/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
7.2%
8/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
28.4%
25/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
27.1%
38/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
48.3%
29/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
65.8%
73/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
8.0%
7/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
7.1%
10/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
20.0%
12/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
19.8%
22/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
22/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
21.4%
30/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
16.7%
10/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
23.4%
26/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Alkaline phosphatase increased
|
8.0%
7/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
4.3%
6/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
11.4%
10/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
13.6%
19/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.7%
4/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
11.7%
13/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Blood bilirubin increased
|
8.0%
7/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
7.1%
10/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
7.2%
8/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
CD4 lymphocytes decreased
|
12.5%
11/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
17.1%
24/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.3%
2/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.8%
2/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Creatinine increased
|
10.2%
9/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
12.1%
17/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.0%
6/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
11.7%
13/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Investigations - Other
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.6%
5/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Lymphocyte count decreased
|
46.6%
41/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
45.0%
63/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
46.7%
28/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
36.0%
40/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Neutrophil count decreased
|
15.9%
14/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
18.6%
26/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
16.7%
10/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.1%
9/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Platelet count decreased
|
52.3%
46/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
45.7%
64/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
43.3%
26/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
43.2%
48/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Weight gain
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.7%
8/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.3%
5/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.6%
4/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Weight loss
|
14.8%
13/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
16.4%
23/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.0%
6/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.4%
6/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
White blood cell decreased
|
33.0%
29/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
33.6%
47/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
36.7%
22/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
19.8%
22/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
39.8%
35/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
30.7%
43/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
31.7%
19/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
32.4%
36/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
4/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
4.3%
6/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.8%
2/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.9%
21/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
31.4%
44/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.7%
4/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
16.2%
18/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.7%
5/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
2.9%
4/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
9.0%
10/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.5%
4/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.4%
9/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.1%
8/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
12.1%
17/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.3%
2/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.3%
7/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.4%
10/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
12.9%
18/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.3%
2/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
7.2%
8/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.4%
10/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
12.1%
17/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
9.0%
10/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.0%
7/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
12.1%
17/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.7%
4/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
11.7%
13/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
3/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.4%
9/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.8%
12/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
4/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
12.1%
17/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
11.7%
13/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.8%
13/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
22.9%
32/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
16.7%
10/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
21.6%
24/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
5.7%
5/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
9.3%
13/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
15.0%
9/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
25.2%
28/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
7.9%
11/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.3%
5/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
12.6%
14/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.7%
8/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
13.3%
8/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
16.2%
18/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
4.5%
4/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
7.1%
10/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.3%
2/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.1%
9/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
4.3%
6/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.3%
2/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
9.0%
10/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.5%
4/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
2.9%
4/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
4.5%
5/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
7/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.6%
12/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.3%
5/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
13.5%
15/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Amnesia
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
7.9%
11/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.4%
6/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Ataxia
|
5.7%
5/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
7/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.0%
6/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
18.9%
21/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Central nervous system necrosis
|
3.4%
3/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
13.6%
19/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
7.2%
8/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Cognitive disturbance
|
11.4%
10/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
14.3%
20/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
13.5%
15/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Concentration impairment
|
5.7%
5/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
7.9%
11/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
4.5%
5/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Dizziness
|
22.7%
20/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
22.9%
32/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
28.3%
17/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
37.8%
42/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Dysarthria
|
9.1%
8/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.4%
9/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
11.7%
7/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
9.0%
10/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Dysgeusia
|
10.2%
9/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
22.9%
32/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.7%
4/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
14.4%
16/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Dysphasia
|
10.2%
9/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
11.4%
16/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
25.0%
15/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
34.2%
38/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Facial muscle weakness
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
4.3%
6/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.8%
2/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Headache
|
50.0%
44/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
48.6%
68/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
75.0%
45/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
63.1%
70/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Memory impairment
|
28.4%
25/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
29.3%
41/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
21.7%
13/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
20.7%
23/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Nervous system disorders - Other
|
6.8%
6/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.7%
15/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.0%
6/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
13.5%
15/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Paresthesia
|
8.0%
7/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
7.9%
11/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.3%
2/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.8%
12/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.1%
8/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.6%
12/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.0%
6/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
16.2%
18/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Seizure
|
20.5%
18/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
20.7%
29/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
30.0%
18/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
42.3%
47/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Somnolence
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.4%
2/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Nervous system disorders
Tremor
|
6.8%
6/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.4%
9/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
13.3%
8/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
4.5%
5/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Psychiatric disorders
Agitation
|
5.7%
5/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
4.3%
6/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
7.2%
8/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Psychiatric disorders
Anxiety
|
11.4%
10/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
15.0%
21/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
16.7%
10/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
16.2%
18/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Psychiatric disorders
Confusion
|
15.9%
14/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
20.0%
28/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
31.7%
19/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
24.3%
27/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Psychiatric disorders
Depression
|
13.6%
12/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
17.9%
25/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
25.0%
15/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
18.0%
20/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Psychiatric disorders
Insomnia
|
17.0%
15/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
23.6%
33/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
26.7%
16/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
34.2%
38/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
3.4%
3/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
2.1%
3/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.90%
1/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
3.4%
3/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.7%
8/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.4%
6/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.3%
2/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.6%
12/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.3%
2/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
9.9%
11/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.1%
1/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
2.9%
4/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
10/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
11.4%
16/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.7%
4/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.8%
12/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.7%
5/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
7.9%
11/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.3%
5/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
11.7%
13/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
58.0%
51/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
60.7%
85/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
83.3%
50/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
73.9%
82/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.0%
15/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.4%
9/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.4%
6/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
4.5%
4/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.4%
9/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
2.7%
3/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.4%
6/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
8/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
9.3%
13/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.3%
5/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
6.3%
7/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.6%
5/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.6%
4/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.9%
14/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.7%
8/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
13.3%
8/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
14.4%
16/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
5.7%
5/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.6%
5/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.4%
6/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
11.4%
10/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.6%
12/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
8.3%
5/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.8%
12/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
10.2%
9/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
16.4%
23/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
1.7%
1/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
3.6%
4/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Vascular disorders
Hypertension
|
8.0%
7/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
12.9%
18/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
13.3%
8/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
17.1%
19/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Vascular disorders
Thromboembolic event
|
8.0%
7/88 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.0%
14/140 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.0%
3/60 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.8%
12/111 • Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in randomized participants who started protocol treatment.
|
Additional Information
Results disclosure agreements
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