Trial Outcomes & Findings for HKI-272 for HER2-Positive Breast Cancer and Brain Metastases (NCT NCT01494662)
NCT ID: NCT01494662
Last Updated: 2026-01-23
Results Overview
Defined as the percentage of patients achieving a complete response (CR) or partial response (PR) of Central Nervous System (CNS) lesions based on composite criteria, reported separately in Cohorts 1, 3A, 3B. For the volumetric criteria, an objective CR will be defined as the following: Disappearance of all CNS target and non-target lesions sustained for at least 4 weeks; no new lesions; stable or decreasing steroid dose; stable or improved neurological symptoms. An objective PR by volumetric criteria will be defined as the following: At least a 50% decrease in the sum volume of CNS target lesions, taking as reference the baseline sum volume sustained for at least 4 weeks; no new lesions; stable or decreasing steroid dose; stable or improved neurological symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
140 participants
Primary outcome timeframe
2 years
Results posted on
2026-01-23
Participant Flow
Participant milestones
| Measure |
Cohort 1
Patients With Progressive Brain Metastases. Intervention: HKI-272 (Neratinib) 240 mg orally, once daily.
|
Cohort 2
Cohort 2 will be made up of participants who are candidates for craniotomy. They will be given Neratinib (240 mg orally daily).
|
Cohort 3A
Cohort 3a will be made up of participants with No Prior Lapatinib Treatment. They will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 3B
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 4A
Cohort 4a will be made up of participants with previously untreated brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 4B
Cohort 4b will be made up of participants with progressive brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 4C
Cohort 4c will be made up of participants with progressive brain metastases and prior T-DM1. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
5
|
39
|
12
|
6
|
17
|
21
|
|
Overall Study
COMPLETED
|
40
|
5
|
37
|
12
|
6
|
17
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
Patients With Progressive Brain Metastases. Intervention: HKI-272 (Neratinib) 240 mg orally, once daily.
|
Cohort 2
Cohort 2 will be made up of participants who are candidates for craniotomy. They will be given Neratinib (240 mg orally daily).
|
Cohort 3A
Cohort 3a will be made up of participants with No Prior Lapatinib Treatment. They will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 3B
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 4A
Cohort 4a will be made up of participants with previously untreated brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 4B
Cohort 4b will be made up of participants with progressive brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 4C
Cohort 4c will be made up of participants with progressive brain metastases and prior T-DM1. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
HKI-272 for HER2-Positive Breast Cancer and Brain Metastases
Baseline characteristics by cohort
| Measure |
Cohort 1
n=40 Participants
Patients With Progressive Brain Metastases. Intervention: HKI-272 (Neratinib) 240 mg orally, once daily.
|
Cohort 2
n=5 Participants
Cohort 2 will be made up of participants who are candidates for craniotomy. They will be given Neratinib (240 mg orally daily).
|
Cohort 3A
n=37 Participants
Cohort 3a will be made up of participants with No Prior Lapatinib Treatment. They will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 3B
n=12 Participants
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 4A
n=6 Participants
Cohort 4a will be made up of participants with previously untreated brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 4B
n=17 Participants
Cohort 4b will be made up of participants with progressive brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 4C
n=21 Participants
Cohort 4c will be made up of participants with progressive brain metastases and prior T-DM1. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
1 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=2259 Participants
|
2 Participants
n=1 Participants
|
|
Age, Continuous
|
50 years
n=270 Participants
|
43 years
n=4 Participants
|
54 years
n=9 Participants
|
52.5 years
n=220 Participants
|
51 years
n=3 Participants
|
48 years
n=18 Participants
|
47 years
n=2259 Participants
|
50 years
n=1 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=270 Participants
|
5 Participants
n=4 Participants
|
37 Participants
n=9 Participants
|
12 Participants
n=220 Participants
|
6 Participants
n=3 Participants
|
17 Participants
n=18 Participants
|
20 Participants
n=2259 Participants
|
136 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=220 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
6 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=270 Participants
|
5 Participants
n=4 Participants
|
34 Participants
n=9 Participants
|
11 Participants
n=220 Participants
|
5 Participants
n=3 Participants
|
14 Participants
n=18 Participants
|
20 Participants
n=2259 Participants
|
123 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=18 Participants
|
1 Participants
n=2259 Participants
|
9 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
34 Participants
n=270 Participants
|
5 Participants
n=4 Participants
|
32 Participants
n=9 Participants
|
7 Participants
n=220 Participants
|
4 Participants
n=3 Participants
|
14 Participants
n=18 Participants
|
20 Participants
n=2259 Participants
|
116 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=220 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=2259 Participants
|
7 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
5 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race · Other or More than One Race
|
2 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
3 Participants
n=220 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
10 Participants
n=1 Participants
|
|
Site of Metastatic Disease: Central Nervous System (CNS) Parenchymal
Yes
|
40 Participants
n=270 Participants
|
5 Participants
n=4 Participants
|
37 Participants
n=9 Participants
|
12 Participants
n=220 Participants
|
6 Participants
n=3 Participants
|
17 Participants
n=18 Participants
|
21 Participants
n=2259 Participants
|
138 Participants
n=1 Participants
|
|
Site of Metastatic Disease: Central Nervous System (CNS) Parenchymal
No
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
0 Participants
n=1 Participants
|
|
Site of Metastatic Disease: CNS Leptomeningeal
Yes
|
4 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
1 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=18 Participants
|
2 Participants
n=2259 Participants
|
11 Participants
n=1 Participants
|
|
Site of Metastatic Disease: CNS Leptomeningeal
No
|
36 Participants
n=270 Participants
|
4 Participants
n=4 Participants
|
35 Participants
n=9 Participants
|
11 Participants
n=220 Participants
|
6 Participants
n=3 Participants
|
16 Participants
n=18 Participants
|
19 Participants
n=2259 Participants
|
127 Participants
n=1 Participants
|
|
Site of Metastatic Disease: CNS Leptomeningeal
Unknown/Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
0 Participants
n=1 Participants
|
|
Site of Metastatic Disease: Lung/Pleural
Yes
|
15 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=9 Participants
|
4 Participants
n=220 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=18 Participants
|
6 Participants
n=2259 Participants
|
38 Participants
n=1 Participants
|
|
Site of Metastatic Disease: Lung/Pleural
No
|
25 Participants
n=270 Participants
|
5 Participants
n=4 Participants
|
28 Participants
n=9 Participants
|
8 Participants
n=220 Participants
|
5 Participants
n=3 Participants
|
14 Participants
n=18 Participants
|
15 Participants
n=2259 Participants
|
100 Participants
n=1 Participants
|
|
Site of Metastatic Disease: Breast or Chest Wall
Yes
|
2 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=9 Participants
|
1 Participants
n=220 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=18 Participants
|
1 Participants
n=2259 Participants
|
17 Participants
n=1 Participants
|
|
Site of Metastatic Disease: Breast or Chest Wall
No
|
38 Participants
n=270 Participants
|
5 Participants
n=4 Participants
|
31 Participants
n=9 Participants
|
11 Participants
n=220 Participants
|
4 Participants
n=3 Participants
|
12 Participants
n=18 Participants
|
20 Participants
n=2259 Participants
|
121 Participants
n=1 Participants
|
|
Site of Metastatic Disease: Lymph Node
Yes
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=9 Participants
|
2 Participants
n=220 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=18 Participants
|
6 Participants
n=2259 Participants
|
17 Participants
n=1 Participants
|
|
Site of Metastatic Disease: Lymph Node
No
|
40 Participants
n=270 Participants
|
5 Participants
n=4 Participants
|
31 Participants
n=9 Participants
|
10 Participants
n=220 Participants
|
5 Participants
n=3 Participants
|
15 Participants
n=18 Participants
|
15 Participants
n=2259 Participants
|
121 Participants
n=1 Participants
|
|
Site of Metastatic Disease: Liver
Yes
|
16 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=9 Participants
|
2 Participants
n=220 Participants
|
3 Participants
n=3 Participants
|
7 Participants
n=18 Participants
|
3 Participants
n=2259 Participants
|
41 Participants
n=1 Participants
|
|
Site of Metastatic Disease: Liver
No
|
24 Participants
n=270 Participants
|
5 Participants
n=4 Participants
|
27 Participants
n=9 Participants
|
10 Participants
n=220 Participants
|
3 Participants
n=3 Participants
|
10 Participants
n=18 Participants
|
18 Participants
n=2259 Participants
|
97 Participants
n=1 Participants
|
|
Site of Metastatic Disease: Bone
Yes
|
26 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
21 Participants
n=9 Participants
|
2 Participants
n=220 Participants
|
5 Participants
n=3 Participants
|
9 Participants
n=18 Participants
|
13 Participants
n=2259 Participants
|
76 Participants
n=1 Participants
|
|
Site of Metastatic Disease: Bone
No
|
14 Participants
n=270 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=9 Participants
|
10 Participants
n=220 Participants
|
1 Participants
n=3 Participants
|
8 Participants
n=18 Participants
|
8 Participants
n=2259 Participants
|
62 Participants
n=1 Participants
|
|
Site of Metastatic Disease: Soft Tissue
Yes
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=18 Participants
|
1 Participants
n=2259 Participants
|
3 Participants
n=1 Participants
|
|
Site of Metastatic Disease: Soft Tissue
No
|
40 Participants
n=270 Participants
|
5 Participants
n=4 Participants
|
37 Participants
n=9 Participants
|
12 Participants
n=220 Participants
|
6 Participants
n=3 Participants
|
15 Participants
n=18 Participants
|
20 Participants
n=2259 Participants
|
135 Participants
n=1 Participants
|
|
Estrogen Receptor Status (Metastatic Sample)
Negative
|
18 Participants
n=270 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=9 Participants
|
6 Participants
n=220 Participants
|
1 Participants
n=3 Participants
|
7 Participants
n=18 Participants
|
11 Participants
n=2259 Participants
|
63 Participants
n=1 Participants
|
|
Estrogen Receptor Status (Metastatic Sample)
Positive
|
22 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
21 Participants
n=9 Participants
|
6 Participants
n=220 Participants
|
5 Participants
n=3 Participants
|
8 Participants
n=18 Participants
|
7 Participants
n=2259 Participants
|
69 Participants
n=1 Participants
|
|
Estrogen Receptor Status (Metastatic Sample)
Missing
|
0 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=18 Participants
|
3 Participants
n=2259 Participants
|
6 Participants
n=1 Participants
|
|
Has the patient had prior surgery for CNS tumors?
Yes
|
12 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=9 Participants
|
3 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
7 Participants
n=18 Participants
|
7 Participants
n=2259 Participants
|
43 Participants
n=1 Participants
|
|
Has the patient had prior surgery for CNS tumors?
No
|
28 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
26 Participants
n=9 Participants
|
9 Participants
n=220 Participants
|
6 Participants
n=3 Participants
|
10 Participants
n=18 Participants
|
14 Participants
n=2259 Participants
|
95 Participants
n=1 Participants
|
|
Prior Stereotactic Radiosurgery (SRS)
Yes
|
25 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=9 Participants
|
7 Participants
n=220 Participants
|
1 Participants
n=3 Participants
|
12 Participants
n=18 Participants
|
10 Participants
n=2259 Participants
|
71 Participants
n=1 Participants
|
|
Prior Stereotactic Radiosurgery (SRS)
No
|
15 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
24 Participants
n=9 Participants
|
5 Participants
n=220 Participants
|
5 Participants
n=3 Participants
|
5 Participants
n=18 Participants
|
11 Participants
n=2259 Participants
|
67 Participants
n=1 Participants
|
|
Prior Whole Brain Radiotherapy (WBRT)
Yes
|
31 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
24 Participants
n=9 Participants
|
5 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
12 Participants
n=18 Participants
|
11 Participants
n=2259 Participants
|
86 Participants
n=1 Participants
|
|
Prior Whole Brain Radiotherapy (WBRT)
No
|
9 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=9 Participants
|
7 Participants
n=220 Participants
|
6 Participants
n=3 Participants
|
5 Participants
n=18 Participants
|
10 Participants
n=2259 Participants
|
52 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: ORR by composite criteria evaluated for all subjects who received at least one dose of study treatment
Defined as the percentage of patients achieving a complete response (CR) or partial response (PR) of Central Nervous System (CNS) lesions based on composite criteria, reported separately in Cohorts 1, 3A, 3B. For the volumetric criteria, an objective CR will be defined as the following: Disappearance of all CNS target and non-target lesions sustained for at least 4 weeks; no new lesions; stable or decreasing steroid dose; stable or improved neurological symptoms. An objective PR by volumetric criteria will be defined as the following: At least a 50% decrease in the sum volume of CNS target lesions, taking as reference the baseline sum volume sustained for at least 4 weeks; no new lesions; stable or decreasing steroid dose; stable or improved neurological symptoms.
Outcome measures
| Measure |
Cohort 2
n=37 Participants
Cohort 2 will be made up of participants who are candidates for craniotomy. They will be given Neratinib (240 mg orally daily).
|
Cohort 1
n=40 Participants
Patients With Progressive Brain Metastases. Intervention: HKI-272 (Neratinib)340 mg orally, once daily.
|
Cohort 4C
Cohort 4c will be made up of participants with progressive brain metastases and prior T-DM1. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 3B
n=12 Participants
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 3B
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 4A
Cohort 4a will be made up of participants with previously untreated brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 4B
Cohort 4b will be made up of participants with progressive brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate Per Composite Response Criteria
|
48.6 percent of participants
Interval 31.9 to 65.6
|
7.5 percent of participants
Interval 1.6 to 20.4
|
—
|
33.3 percent of participants
Interval 9.9 to 65.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Analysis population consists of all subjects who received at least one dose of treatment. All subjects enrolled in Cohorts 4A, 4B, and 4C received at least one dose of treatment, so all enrolled subjects are included in the objective response rate (ORR)
Defined as the percentage of patients achieving a complete response (CR) or partial response (PR) of Central Nervous System (CNS) lesions based on RANO-BM criteria, reported separately in Cohorts 4A, 4B, and 4C. For the RANO-BM criteria, an objective CR will be defined as the following: Disappearance of all CNS target and non-target lesions sustained for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. An objective PR by RANO-BM criteria will be defined as the following: At least a 30% decrease in the sum LD of CNS target lesions, taking as reference the baseline sum LD sustained for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically.
Outcome measures
| Measure |
Cohort 2
n=17 Participants
Cohort 2 will be made up of participants who are candidates for craniotomy. They will be given Neratinib (240 mg orally daily).
|
Cohort 1
n=6 Participants
Patients With Progressive Brain Metastases. Intervention: HKI-272 (Neratinib)340 mg orally, once daily.
|
Cohort 4C
Cohort 4c will be made up of participants with progressive brain metastases and prior T-DM1. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 3B
n=21 Participants
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 3B
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 4A
Cohort 4a will be made up of participants with previously untreated brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 4B
Cohort 4b will be made up of participants with progressive brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate Per RANO-BM Criteria
|
35.3 percent of participants
Interval 14.2 to 61.7
|
33.3 percent of participants
Interval 4.3 to 77.7
|
—
|
28.6 percent of participants
Interval 11.3 to 52.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed from date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, up to 3 yearsPopulation: PFS analyzed in all subjects who received at least one dose of study treatment
Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. A participant was considered to have an event if they had a CNS progression (defined by RANO-BM criteria for Cohort 4A, 4B, 4C, or defined by composite/volumetric criteria for Cohort 1 and Cohorts 3A and 3B), if they a non-CNS progression as defined by RECIST v1.1 criteria, or if they died without a progression within two cycle lengths (42 days) after their last scan date. Participants alive without disease progression are censored at the date of their last disease evaluation.
Outcome measures
| Measure |
Cohort 2
n=5 Participants
Cohort 2 will be made up of participants who are candidates for craniotomy. They will be given Neratinib (240 mg orally daily).
|
Cohort 1
n=40 Participants
Patients With Progressive Brain Metastases. Intervention: HKI-272 (Neratinib)340 mg orally, once daily.
|
Cohort 4C
n=21 Participants
Cohort 4c will be made up of participants with progressive brain metastases and prior T-DM1. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 3B
n=37 Participants
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 3B
n=12 Participants
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 4A
n=6 Participants
Cohort 4a will be made up of participants with previously untreated brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 4B
n=17 Participants
Cohort 4b will be made up of participants with progressive brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Progression-Free Survival
|
2.37 months
Interval 2.07 to
Upper bound of confidence interval not estimable due to insufficient number of events
|
1.9 months
Interval 1.8 to 3.5
|
4.14 months
Interval 2.73 to 6.34
|
5.5 months
Interval 4.6 to 8.1
|
3.1 months
Interval 1.97 to
Upper bound of confidence interval not estimable due to insufficient number of events
|
5.26 months
Interval 4.47 to
Upper bound of confidence interval not estimable due to insufficient number of events
|
4.11 months
Interval 2.69 to
Upper bound of confidence interval not estimable due to insufficient number of events
|
SECONDARY outcome
Timeframe: Assessed from date of trial registration until the date of death from any cause, up to 5 yearsPopulation: OS evaluated for all subjects who completed the study, defined as all subjects who received at least one dose of study treatment.
Overall survival (OS) is the defined as the duration of time from the date of trial registration to death.
Outcome measures
| Measure |
Cohort 2
n=5 Participants
Cohort 2 will be made up of participants who are candidates for craniotomy. They will be given Neratinib (240 mg orally daily).
|
Cohort 1
n=40 Participants
Patients With Progressive Brain Metastases. Intervention: HKI-272 (Neratinib)340 mg orally, once daily.
|
Cohort 4C
n=21 Participants
Cohort 4c will be made up of participants with progressive brain metastases and prior T-DM1. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 3B
n=37 Participants
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 3B
n=12 Participants
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 4A
n=6 Participants
Cohort 4a will be made up of participants with previously untreated brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 4B
n=17 Participants
Cohort 4b will be made up of participants with progressive brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Survival
|
NA months
Interval 6.24 to
Both the median and the upper bound of confidence interval not estimable due to insufficient number of events
|
8.7 months
Interval 4.9 to 15.1
|
20.86 months
Interval 14.92 to
Upper bound of confidence interval not estimable due to insufficient number of events
|
13.3 months
Interval 10.97 to
Upper bound of confidence interval not estimable due to insufficient number of events
|
15.1 months
Interval 7.0 to
Upper bound of confidence interval not estimable due to insufficient number of events
|
30.16 months
Interval 21.85 to
Upper bound of confidence interval not estimable due to insufficient number of events
|
23.29 months
Interval 17.64 to
Upper bound of confidence interval not estimable due to insufficient number of events
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: ORR by Macdonald (or bidirectional) criteria assessed for all subjects in Cohort 1 who received at least one dose of study treatment
Defined as either a complete or partial response based on the Macdonald criteria. In the Macdonald response criteria, a complete response (CR) is defined as: disappearance of all enhancing tumor on consecutive CT or magnetic resonance imaging (MRI) scans at least 1 month apart, off steroids, and neurologically stable or improved. A partial response (PR) is defined as: at least 50% reduction in size of enhancing tumor on consecutive CT or MRI scans at least 1 month apart, steroids stable or reduced, and neurologically stable or improved. Reported for Cohort 1 only.
Outcome measures
| Measure |
Cohort 2
Cohort 2 will be made up of participants who are candidates for craniotomy. They will be given Neratinib (240 mg orally daily).
|
Cohort 1
n=40 Participants
Patients With Progressive Brain Metastases. Intervention: HKI-272 (Neratinib)340 mg orally, once daily.
|
Cohort 4C
Cohort 4c will be made up of participants with progressive brain metastases and prior T-DM1. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 3B
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 3B
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 4A
Cohort 4a will be made up of participants with previously untreated brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 4B
Cohort 4b will be made up of participants with progressive brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
CNS Response by Macdonald Criteria (Bidirectional Criteria)
|
—
|
10.0 percent of participants
Interval 2.8 to 23.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Evaluated for all subjects who received at least one dose of study treatment
Reason for subject being taken off study treatment: CNS progression, non-CNS progression, both CNS and non-CNS progression, or reason other than progression such as toxicity or physician decision. For subjects who came off treatment for progression, this outcome describes their first site of disease progression (CNS, non-CNS, or both).
Outcome measures
| Measure |
Cohort 2
n=5 Participants
Cohort 2 will be made up of participants who are candidates for craniotomy. They will be given Neratinib (240 mg orally daily).
|
Cohort 1
n=40 Participants
Patients With Progressive Brain Metastases. Intervention: HKI-272 (Neratinib)340 mg orally, once daily.
|
Cohort 4C
n=21 Participants
Cohort 4c will be made up of participants with progressive brain metastases and prior T-DM1. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 3B
n=37 Participants
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 3B
n=12 Participants
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 4A
n=6 Participants
Cohort 4a will be made up of participants with previously untreated brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 4B
n=17 Participants
Cohort 4b will be made up of participants with progressive brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Reason for Subject Being Taken Off Study Treatment
Non-CNS Progression
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Reason for Subject Being Taken Off Study Treatment
CNS and Non-CNS Progression
|
0 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Reason for Subject Being Taken Off Study Treatment
CNS Progression
|
2 Participants
|
29 Participants
|
12 Participants
|
23 Participants
|
8 Participants
|
3 Participants
|
11 Participants
|
|
Reason for Subject Being Taken Off Study Treatment
Patient Withdrew for Other Reasons
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Reason for Subject Being Taken Off Study Treatment
Physician Discretion
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Reason for Subject Being Taken Off Study Treatment
Unacceptable Toxicity
|
0 Participants
|
6 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Reason for Subject Being Taken Off Study Treatment
Subject remained on study treatment at time of evaluation
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Reason for Subject Being Taken Off Study Treatment
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Reason for Subject Being Taken Off Study Treatment
Other off treatment reason
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Of the total 40 subjects in Cohort 1, two patients who experienced non-CNS progression received trastuzumab-neratinib on the extension cohort after one and two cycles of neratinib, respectively.
Assess number of objective responses based on CNS composite criteria for subjects in Cohort 1 who opt to receive trastuzumab and neratinib at the time of non-CNS progression
Outcome measures
| Measure |
Cohort 2
Cohort 2 will be made up of participants who are candidates for craniotomy. They will be given Neratinib (240 mg orally daily).
|
Cohort 1
n=2 Participants
Patients With Progressive Brain Metastases. Intervention: HKI-272 (Neratinib)340 mg orally, once daily.
|
Cohort 4C
Cohort 4c will be made up of participants with progressive brain metastases and prior T-DM1. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 3B
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 3B
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 4A
Cohort 4a will be made up of participants with previously untreated brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 4B
Cohort 4b will be made up of participants with progressive brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Objective Response Based on CNS Composite Criteria for Extension Subgroup of Cohort 1
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Objective response rate in CNS by volumetric criteria evaluated for all subjects who received at least one dose of study treatment
Defined as the percentage of patients achieving a complete response (CR) or partial response (PR) of Central Nervous System (CNS) lesions based on volumetric criteria, reported separately in Cohorts 4A, 4B, and 4C. For the volumetric criteria, an objective CR will be defined as the following: Disappearance of all CNS target and non-target lesions sustained for at least 4 weeks; no new lesions. An objective PR by volumetric criteria will be defined as the following: At least a 50% decrease in the sum volume of CNS target lesions, taking as reference the baseline sum volume sustained for at least 4 weeks; no new lesions.
Outcome measures
| Measure |
Cohort 2
n=17 Participants
Cohort 2 will be made up of participants who are candidates for craniotomy. They will be given Neratinib (240 mg orally daily).
|
Cohort 1
n=6 Participants
Patients With Progressive Brain Metastases. Intervention: HKI-272 (Neratinib)340 mg orally, once daily.
|
Cohort 4C
Cohort 4c will be made up of participants with progressive brain metastases and prior T-DM1. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 3B
n=21 Participants
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 3B
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 4A
Cohort 4a will be made up of participants with previously untreated brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 4B
Cohort 4b will be made up of participants with progressive brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate in CNS by Volumetric Criteria
|
29.4 percent of participants
Interval 10.3 to 56.0
|
50.0 percent of participants
Interval 11.8 to 88.2
|
—
|
23.8 percent of participants
Interval 8.2 to 47.2
|
—
|
—
|
—
|
Adverse Events
Cohort 1
Serious events: 1 serious events
Other events: 38 other events
Deaths: 34 deaths
Cohort 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 2 deaths
Cohort 3A
Serious events: 0 serious events
Other events: 35 other events
Deaths: 21 deaths
Cohort 3B
Serious events: 0 serious events
Other events: 12 other events
Deaths: 6 deaths
Cohort 4A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 3 deaths
Cohort 4B
Serious events: 1 serious events
Other events: 17 other events
Deaths: 8 deaths
Cohort 4C
Serious events: 0 serious events
Other events: 21 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Cohort 1
n=40 participants at risk
Patients With Progressive Brain Metastases. Intervention: HKI-272 (Neratinib)340 mg orally, once daily.
|
Cohort 2
n=5 participants at risk
Cohort 2 will be made up of participants who are candidates for craniotomy. They will be given Neratinib (240 mg orally daily).
|
Cohort 3A
n=37 participants at risk
Cohort 3a will be made up of participants with No Prior Lapatinib Treatment. They will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 3B
n=12 participants at risk
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 4A
n=6 participants at risk
Cohort 4a will be made up of participants with previously untreated brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 4B
n=17 participants at risk
Cohort 4b will be made up of participants with progressive brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 4C
n=21 participants at risk
Cohort 4c will be made up of participants with progressive brain metastases and prior T-DM1. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
Other adverse events
| Measure |
Cohort 1
n=40 participants at risk
Patients With Progressive Brain Metastases. Intervention: HKI-272 (Neratinib)340 mg orally, once daily.
|
Cohort 2
n=5 participants at risk
Cohort 2 will be made up of participants who are candidates for craniotomy. They will be given Neratinib (240 mg orally daily).
|
Cohort 3A
n=37 participants at risk
Cohort 3a will be made up of participants with No Prior Lapatinib Treatment. They will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 3B
n=12 participants at risk
Cohort 3b will be made of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
|
Cohort 4A
n=6 participants at risk
Cohort 4a will be made up of participants with previously untreated brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 4B
n=17 participants at risk
Cohort 4b will be made up of participants with progressive brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
Cohort 4C
n=21 participants at risk
Cohort 4c will be made up of participants with progressive brain metastases and prior T-DM1. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Stomach pain
|
12.5%
5/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
41.7%
5/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
50.0%
3/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
8/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
56.8%
21/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
41.7%
5/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
50.0%
3/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
52.9%
9/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
42.9%
9/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
2/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
13.5%
5/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
41.7%
5/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
50.0%
3/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
General disorders
Fatigue
|
50.0%
20/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
40.0%
2/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.4%
2/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
66.7%
4/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
42.9%
9/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
7.5%
3/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
40.0%
2/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
4/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
47.1%
8/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
General disorders
Non-cardiac chest pain
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
40.0%
2/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
51.4%
19/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
25.0%
3/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
General disorders
Pain
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
40.0%
2/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
13.5%
5/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
9.5%
2/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
General disorders
Infusion related reaction
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
40.0%
2/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.1%
3/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
9.5%
2/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
General disorders
Infusion site extravasation
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
40.0%
2/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
9.5%
2/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
General disorders and administration site conditions
Edema face
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.4%
2/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
General disorders and administration site conditions
Fatigue
|
50.0%
20/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
51.4%
19/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Investigations
Neutrophil count decreased
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
2/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
9.5%
2/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Investigations
Platelet count decreased
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
23.8%
5/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Investigations
Weight loss
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
17.6%
3/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Cardiac disorders
Ventricular tachycardia
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Ear and labyrinth disorders
Ear pain
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Ear and labyrinth disorders
Tinnitus
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Ear and labyrinth disorders
Vertigo
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Eye disorders
Photophobia
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
40.0%
2/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.4%
2/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Eye disorders
Eye disorders - Other, specify
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.4%
2/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
17.6%
3/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
40.0%
2/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
41.7%
5/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
23.8%
5/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Bloating
|
5.0%
2/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
60.0%
3/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
25.0%
3/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
14.3%
3/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Colitis
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
91.7%
11/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
100.0%
6/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
58.8%
10/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Constipation
|
32.5%
13/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
21.6%
8/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
76.5%
13/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
76.2%
16/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
80.0%
32/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
86.5%
32/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
66.7%
8/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
23.5%
4/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
81.0%
17/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
5/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
41.7%
5/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
2/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
19.0%
4/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Dyspepsia
|
7.5%
3/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.4%
2/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
41.7%
5/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
50.0%
3/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
9.5%
2/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Investigations
White blood cell decreased
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.4%
2/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
17.6%
3/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
22.5%
9/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
27.0%
10/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
2/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
29.4%
5/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
14.3%
3/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Metabolism and nutrition disorders
Dehydration
|
7.5%
3/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.1%
3/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
25.0%
3/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
9.5%
2/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
2/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
40.0%
2/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
2/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
23.5%
4/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
9.5%
2/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
2/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
9.5%
2/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.5%
3/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
40.0%
2/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
9.5%
2/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.5%
3/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
40.0%
2/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
10.8%
4/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
9.5%
2/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Psychiatric disorders
Insomnia
|
10.0%
4/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
2/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
9.5%
2/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Psychiatric disorders
Depression
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.1%
3/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
9.5%
2/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Renal and urinary disorders
Urinary frequency
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Vascular disorders
Thromboembolic event
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
2/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
60.0%
3/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
2/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
60.0%
3/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
2/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
2/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
60.0%
3/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
10.8%
4/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
2/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
2/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
14.3%
3/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.00%
0/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Eye disorders
Dry eye
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
40.0%
2/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
2/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
41.7%
5/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
50.0%
3/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Mucositis oral
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
41.7%
5/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
50.0%
3/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
14.3%
3/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Nausea
|
5.0%
2/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
41.7%
5/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
50.0%
3/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
52.4%
11/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
General disorders and administration site conditions
Gait disturbance
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
51.4%
19/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
General disorders and administration site conditions
General disorders and administration site conditions - Other, specify
|
7.5%
3/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
51.4%
19/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Immune system disorders
Immune system disorders - Other, specify
|
0.00%
0/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Infections and infestations
Papulopustular rash
|
5.0%
2/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.4%
2/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Infections and infestations
Paronychia
|
5.0%
2/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Infections and infestations
Rhinitis infective
|
5.0%
2/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Infections and infestations
Urinary tract infection
|
5.0%
2/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
60.0%
3/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.4%
2/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Infections and infestations
Upper respiratory infection
|
5.0%
2/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
60.0%
3/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.1%
3/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Injury, poisoning and procedural complications
Bruising
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
2/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
14.3%
3/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
2/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
13.5%
5/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
2/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
2/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
29.4%
5/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
23.8%
5/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Investigations
Alkaline phosphatase increased
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
10.8%
4/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
2/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
2/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
23.5%
4/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Investigations
Aspartate aminotransferase increased
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.4%
2/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
50.0%
3/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
35.3%
6/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
28.6%
6/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Investigations
Blood bilirubin increased
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Investigations
Ejection fraction decreased
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
2/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.0%
2/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
4/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
17.6%
3/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
9.5%
2/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
3/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.4%
2/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
4/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
9.5%
2/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
7.5%
3/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.4%
2/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
4/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
9.5%
2/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
7.5%
3/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
4/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
9.5%
2/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Nervous system disorders
Ataxia
|
7.5%
3/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Nervous system disorders
Encephalopathy
|
22.5%
9/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
40.0%
2/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
10.8%
4/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
41.7%
5/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
14.3%
3/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.0%
2/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.4%
2/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
2/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
14.3%
3/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Nervous system disorders
Seizure
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
14.3%
3/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
22.5%
9/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
27.0%
10/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
14.3%
3/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Nervous system disorders
Tremor
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
14.3%
3/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Nervous system disorders
Syncope
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
14.3%
3/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Renal and urinary disorders
Urinary incontinence
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Reproductive system and breast disorders
Breast pain
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
11.8%
2/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
9.5%
2/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
4/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.1%
3/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
17.6%
3/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
38.1%
8/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.0%
2/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.4%
2/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.4%
2/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.4%
2/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.0%
2/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.4%
2/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.4%
2/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
40.0%
2/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.7%
1/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.5%
3/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.1%
3/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
25.0%
3/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
2/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
14.3%
3/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
16.2%
6/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
2/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Skin and subcutaneous tissue disorders
Skin/subcutaneous tissue disorders; Other, specify
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
13.5%
5/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
2/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
2/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
2/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
2/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
5.9%
1/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Vascular disorders
Lymphedema
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
2/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
|
Vascular disorders
Hypertension
|
2.5%
1/40 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
20.0%
1/5 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
2.7%
1/37 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
8.3%
1/12 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
33.3%
2/6 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
0.00%
0/17 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
4.8%
1/21 • All-Cause Mortality was assessed up to 5 years; all adverse events were collected up to 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place