Trial Outcomes & Findings for Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation (NCT NCT03318939)
NCT ID: NCT03318939
Last Updated: 2026-06-12
Results Overview
ORR was defined as the percentage of participants whose best overall response (BOR) was confirmed to be complete response (CR) or partial response (PR) from the first dose of poziotinib until the last tumor assessment on study. ORR was assessed by the Independent Radiologic Review Committee according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all non-nodal target lesions. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
648 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2026-06-12
Participant Flow
Participants were enrolled at 62 investigative sites from 11 October 2017 to 03 April 2023.
A total of 648 participants were enrolled and dosed with Poziotinib.
Participant milestones
| Measure |
Cohort 1: Poziotinib 16 mg
Participants previously treated for epidermal growth factor receptor (EGFR) exon 20 insertion mutation-positive non-small cell lung cancer (NSCLC) received poziotinib, 16 milligrams (mg), orally, once daily (QD) in each 28-day cycle until disease progression, death, intolerable adverse events (AEs), or for up to a maximum of 35 months, whichever occurs first.
|
Cohort 2: Poziotinib 16 mg
Participants previously treated for human epidermal growth factor receptor 2 (HER2) exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
|
Cohort 3: Poziotinib 16 mg
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
|
Cohort 4: Poziotinib 8 mg
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg, orally, twice daily (BID) in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
|
Cohort 4: Poziotinib 16 mg
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
|
Cohort 5: Poziotinib 6 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 23 months, whichever occurs first.
|
Cohort 5: Poziotinib 8mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 25 months, whichever occurs first.
|
Cohort 5: Poziotinib 10 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 10 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 15 months, whichever occurs first.
|
Cohort 5: Poziotinib 12 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 12 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
|
Cohort 5: Poziotinib 16 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 18 months, whichever occurs first.
|
Cohort 6: Poziotinib 8 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
|
Cohort 6: Poziotinib 16 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 7 months, whichever occurs first.
|
Cohort 7: Poziotinib 8 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
|
Cohort 7: Poziotinib 16 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 4 months, whichever occurs first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
115
|
90
|
80
|
33
|
47
|
38
|
125
|
35
|
25
|
26
|
7
|
1
|
17
|
9
|
|
Overall Study
COMPLETED
|
1
|
0
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
114
|
90
|
78
|
33
|
46
|
38
|
125
|
35
|
25
|
26
|
7
|
1
|
17
|
9
|
Reasons for withdrawal
| Measure |
Cohort 1: Poziotinib 16 mg
Participants previously treated for epidermal growth factor receptor (EGFR) exon 20 insertion mutation-positive non-small cell lung cancer (NSCLC) received poziotinib, 16 milligrams (mg), orally, once daily (QD) in each 28-day cycle until disease progression, death, intolerable adverse events (AEs), or for up to a maximum of 35 months, whichever occurs first.
|
Cohort 2: Poziotinib 16 mg
Participants previously treated for human epidermal growth factor receptor 2 (HER2) exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
|
Cohort 3: Poziotinib 16 mg
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
|
Cohort 4: Poziotinib 8 mg
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg, orally, twice daily (BID) in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
|
Cohort 4: Poziotinib 16 mg
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
|
Cohort 5: Poziotinib 6 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 23 months, whichever occurs first.
|
Cohort 5: Poziotinib 8mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 25 months, whichever occurs first.
|
Cohort 5: Poziotinib 10 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 10 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 15 months, whichever occurs first.
|
Cohort 5: Poziotinib 12 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 12 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
|
Cohort 5: Poziotinib 16 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 18 months, whichever occurs first.
|
Cohort 6: Poziotinib 8 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
|
Cohort 6: Poziotinib 16 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 7 months, whichever occurs first.
|
Cohort 7: Poziotinib 8 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
|
Cohort 7: Poziotinib 16 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 4 months, whichever occurs first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
16
|
13
|
9
|
3
|
1
|
3
|
16
|
5
|
3
|
1
|
0
|
0
|
2
|
1
|
|
Overall Study
Initiation of Non-Protocol Therapy
|
3
|
1
|
0
|
1
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Disease Progression
|
61
|
53
|
51
|
21
|
30
|
24
|
56
|
22
|
12
|
14
|
6
|
1
|
5
|
8
|
|
Overall Study
Withdrawal by Subject
|
14
|
5
|
8
|
1
|
4
|
3
|
12
|
4
|
3
|
6
|
0
|
0
|
1
|
0
|
|
Overall Study
Delay of Poziotinib Administration For More Than 28 Days Since Last Administration
|
0
|
2
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
2
|
0
|
0
|
1
|
0
|
|
Overall Study
Investigator Decision
|
4
|
0
|
1
|
0
|
1
|
1
|
6
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
0
|
5
|
0
|
3
|
12
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
14
|
10
|
7
|
1
|
5
|
3
|
7
|
2
|
4
|
2
|
0
|
0
|
4
|
0
|
|
Overall Study
Reason Not Specified
|
2
|
4
|
1
|
1
|
2
|
1
|
14
|
1
|
2
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation
Baseline characteristics by cohort
| Measure |
Cohort 1: Poziotinib 16 mg
n=115 Participants
Participants previously treated for EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 35 months, whichever occurs first.
|
Cohort 2: Poziotinib 16 mg
n=90 Participants
Participants previously treated for HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
|
Cohort 3: Poziotinib 16 mg
n=80 Participants
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
|
Cohort 4: Poziotinib 8 mg
n=33 Participants
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
|
Cohort 4: Poziotinib 16 mg
n=47 Participants
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
|
Cohort 5: Poziotinib 6 mg
n=38 Participants
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 23 months, whichever occurs first.
|
Cohort 5: Poziotinib 8mg
n=125 Participants
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 25 months, whichever occurs first.
|
Cohort 5: Poziotinib 10 mg
n=35 Participants
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 10 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 15 months, whichever occurs first.
|
Cohort 5: Poziotinib 12 mg
n=25 Participants
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 12 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
|
Cohort 5: Poziotinib 16 mg
n=26 Participants
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 18 months, whichever occurs first.
|
Cohort 6: Poziotinib 8 mg
n=7 Participants
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
|
Cohort 6: Poziotinib 16 mg
n=1 Participants
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 7 months, whichever occurs first.
|
Cohort 7: Poziotinib 8 mg
n=17 Participants
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
|
Cohort 7: Poziotinib 16 mg
n=9 Participants
Participants with EGFR or HER2 activating mutations received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 4 months, whichever occurs first.
|
Total
n=648 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 12.38 • n=9 Participants
|
60.0 years
STANDARD_DEVIATION 11.69 • n=27 Participants
|
59.9 years
STANDARD_DEVIATION 10.44 • n=267 Participants
|
59.6 years
STANDARD_DEVIATION 13.82 • n=265 Participants
|
61.4 years
STANDARD_DEVIATION 12.18 • n=568 Participants
|
59.5 years
STANDARD_DEVIATION 14.65 • n=22 Participants
|
65.0 years
STANDARD_DEVIATION 9.91 • n=23 Participants
|
63.5 years
STANDARD_DEVIATION 10.82 • n=22 Participants
|
62.6 years
STANDARD_DEVIATION 9.95 • n=178 Participants
|
63.6 years
STANDARD_DEVIATION 8.31 • n=116 Participants
|
55.7 years
STANDARD_DEVIATION 10.90 • n=2 Participants
|
34.0 years
STANDARD_DEVIATION NA • n=4 Participants
|
63.0 years
STANDARD_DEVIATION 11.35 • n=190 Participants
|
61.3 years
STANDARD_DEVIATION 6.14 • n=19 Participants
|
59.9 years
STANDARD_DEVIATION 5.59 • n=18 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=9 Participants
|
58 Participants
n=27 Participants
|
45 Participants
n=267 Participants
|
16 Participants
n=265 Participants
|
25 Participants
n=568 Participants
|
23 Participants
n=22 Participants
|
85 Participants
n=23 Participants
|
26 Participants
n=22 Participants
|
19 Participants
n=178 Participants
|
19 Participants
n=116 Participants
|
5 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
15 Participants
n=190 Participants
|
4 Participants
n=19 Participants
|
418 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=9 Participants
|
32 Participants
n=27 Participants
|
35 Participants
n=267 Participants
|
17 Participants
n=265 Participants
|
22 Participants
n=568 Participants
|
15 Participants
n=22 Participants
|
40 Participants
n=23 Participants
|
9 Participants
n=22 Participants
|
6 Participants
n=178 Participants
|
7 Participants
n=116 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=190 Participants
|
5 Participants
n=19 Participants
|
230 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
3 Participants
n=22 Participants
|
2 Participants
n=23 Participants
|
2 Participants
n=22 Participants
|
1 Participants
n=178 Participants
|
2 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
23 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=9 Participants
|
85 Participants
n=27 Participants
|
80 Participants
n=267 Participants
|
33 Participants
n=265 Participants
|
44 Participants
n=568 Participants
|
35 Participants
n=22 Participants
|
123 Participants
n=23 Participants
|
33 Participants
n=22 Participants
|
24 Participants
n=178 Participants
|
24 Participants
n=116 Participants
|
7 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
17 Participants
n=190 Participants
|
9 Participants
n=19 Participants
|
625 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Asian
|
18 Participants
n=9 Participants
|
12 Participants
n=27 Participants
|
15 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
7 Participants
n=568 Participants
|
3 Participants
n=22 Participants
|
17 Participants
n=23 Participants
|
2 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
2 Participants
n=116 Participants
|
3 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
88 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
3 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
5 Participants
n=22 Participants
|
12 Participants
n=23 Participants
|
3 Participants
n=22 Participants
|
3 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=190 Participants
|
1 Participants
n=19 Participants
|
46 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
White
|
77 Participants
n=9 Participants
|
70 Participants
n=27 Participants
|
61 Participants
n=267 Participants
|
27 Participants
n=265 Participants
|
35 Participants
n=568 Participants
|
28 Participants
n=22 Participants
|
90 Participants
n=23 Participants
|
27 Participants
n=22 Participants
|
21 Participants
n=178 Participants
|
21 Participants
n=116 Participants
|
4 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=190 Participants
|
8 Participants
n=19 Participants
|
481 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
2 Participants
n=22 Participants
|
6 Participants
n=23 Participants
|
2 Participants
n=22 Participants
|
1 Participants
n=178 Participants
|
3 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
29 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: As-Treated Population included all participants who received at least one dose of study medication. Data for efficacy outcome measure was planned to be collected and analyzed combined (all doses) for cohorts 4,5, 6, and 7.
ORR was defined as the percentage of participants whose best overall response (BOR) was confirmed to be complete response (CR) or partial response (PR) from the first dose of poziotinib until the last tumor assessment on study. ORR was assessed by the Independent Radiologic Review Committee according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all non-nodal target lesions. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present.
Outcome measures
| Measure |
Cohort 1: Poziotinib 16 mg
n=115 Participants
Participants previously treated for EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 35 months, whichever occurs first.
|
Cohort 2: Poziotinib 16 mg
n=90 Participants
Participants previously treated for HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
|
Cohort 3: Poziotinib 16 mg
n=80 Participants
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
|
Cohort 4: Poziotinib
n=80 Participants
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
|
Cohort 5: Poziotinib
n=248 Participants
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg/ 8 mg BID or 10 mg/ 12 mg/ 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
|
Cohort 6: Poziotinib
n=8 Participants
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
|
Cohort 7: Poziotinib
n=26 Participants
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
|
Cohort 5: Poziotinib 10 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 10 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 15 months, whichever occurs first.
|
Cohort 5: Poziotinib 12 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 12 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
|
Cohort 5: Poziotinib 16 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 18 months, whichever occurs first.
|
Cohort 6: Poziotinib 8 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
|
Cohort 6: Poziotinib 16 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 7 months, whichever occurs first.
|
Cohort 7: Poziotinib 8 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
|
Cohort 7: Poziotinib 16 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 4 months, whichever occurs first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
13.9 percentage of participants
Interval 8.2 to 21.6
|
27.8 percentage of participants
Interval 18.9 to 38.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
39 percentage of participants
Interval 28.0 to 50.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were defined as AEs that occur from the first dose of study treatment until 35 (±5) days after the last dose of study treatment.
Outcome measures
| Measure |
Cohort 1: Poziotinib 16 mg
n=115 Participants
Participants previously treated for EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 35 months, whichever occurs first.
|
Cohort 2: Poziotinib 16 mg
n=90 Participants
Participants previously treated for HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
|
Cohort 3: Poziotinib 16 mg
n=80 Participants
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
|
Cohort 4: Poziotinib
n=33 Participants
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
|
Cohort 5: Poziotinib
n=47 Participants
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg/ 8 mg BID or 10 mg/ 12 mg/ 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
|
Cohort 6: Poziotinib
n=38 Participants
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
|
Cohort 7: Poziotinib
n=125 Participants
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
|
Cohort 5: Poziotinib 10 mg
n=35 Participants
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 10 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 15 months, whichever occurs first.
|
Cohort 5: Poziotinib 12 mg
n=25 Participants
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 12 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
|
Cohort 5: Poziotinib 16 mg
n=26 Participants
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 18 months, whichever occurs first.
|
Cohort 6: Poziotinib 8 mg
n=7 Participants
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
|
Cohort 6: Poziotinib 16 mg
n=1 Participants
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 7 months, whichever occurs first.
|
Cohort 7: Poziotinib 8 mg
n=17 Participants
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
|
Cohort 7: Poziotinib 16 mg
n=9 Participants
Participants with EGFR or HER2 activating mutations received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 4 months, whichever occurs first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
115 Participants
|
90 Participants
|
80 Participants
|
33 Participants
|
47 Participants
|
37 Participants
|
124 Participants
|
35 Participants
|
25 Participants
|
26 Participants
|
6 Participants
|
1 Participants
|
17 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: As-Treated Population included all participants who received at least one dose of study medication. Data for efficacy outcome measure was planned to be collected and analyzed combined (all doses) for cohorts 4,5, 6, and 7.
DCR was defined as percentage of participants with best response of CR, PR, or stable disease (SD) from the first dose of poziotinib to the last tumor assessment on study. CR was defined as the disappearance of all non-nodal target lesion. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present. SD was defined as neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
Outcome measures
| Measure |
Cohort 1: Poziotinib 16 mg
n=115 Participants
Participants previously treated for EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 35 months, whichever occurs first.
|
Cohort 2: Poziotinib 16 mg
n=90 Participants
Participants previously treated for HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
|
Cohort 3: Poziotinib 16 mg
n=80 Participants
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
|
Cohort 4: Poziotinib
n=80 Participants
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
|
Cohort 5: Poziotinib
n=248 Participants
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg/ 8 mg BID or 10 mg/ 12 mg/ 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
|
Cohort 6: Poziotinib
n=8 Participants
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
|
Cohort 7: Poziotinib
n=26 Participants
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
|
Cohort 5: Poziotinib 10 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 10 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 15 months, whichever occurs first.
|
Cohort 5: Poziotinib 12 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 12 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
|
Cohort 5: Poziotinib 16 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 18 months, whichever occurs first.
|
Cohort 6: Poziotinib 8 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
|
Cohort 6: Poziotinib 16 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 7 months, whichever occurs first.
|
Cohort 7: Poziotinib 8 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
|
Cohort 7: Poziotinib 16 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 4 months, whichever occurs first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
67.8 percentage of participants
Interval 58.5 to 76.2
|
70 percentage of participants
Interval 59.4 to 79.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
73 percentage of participants
Interval 61.0 to 82.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: As-Treated Population included all participants who received at least one dose of study medication. Data for efficacy outcome measure was planned to be collected and analyzed combined (all doses) for cohorts 4,5, 6, and 7.
DoR was evaluated only for participants who had CR or PR and was defined as the time from the date that response evaluation criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that PD or death was documented. CR was defined as the disappearance of all non-nodal target lesion. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present. Disease progression was defined as greater than or equal to (≥) 20% increase in the SOD of target lesions taking as reference the nadir SOD (or the baseline, if the baseline is the nadir value). In addition to the relative increase of 20% in SOD, the SOD must also have demonstrated an absolute increase of ≥ 5 mm.
Outcome measures
| Measure |
Cohort 1: Poziotinib 16 mg
n=16 Participants
Participants previously treated for EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 35 months, whichever occurs first.
|
Cohort 2: Poziotinib 16 mg
n=25 Participants
Participants previously treated for HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
|
Cohort 3: Poziotinib 16 mg
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
|
Cohort 4: Poziotinib
n=31 Participants
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
|
Cohort 5: Poziotinib
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg/ 8 mg BID or 10 mg/ 12 mg/ 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
|
Cohort 6: Poziotinib
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
|
Cohort 7: Poziotinib
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg BID or 16 mg QD, orally, in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
|
Cohort 5: Poziotinib 10 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 10 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 15 months, whichever occurs first.
|
Cohort 5: Poziotinib 12 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 12 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
|
Cohort 5: Poziotinib 16 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 18 months, whichever occurs first.
|
Cohort 6: Poziotinib 8 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
|
Cohort 6: Poziotinib 16 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 7 months, whichever occurs first.
|
Cohort 7: Poziotinib 8 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
|
Cohort 7: Poziotinib 16 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 4 months, whichever occurs first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR)
|
6.5 months
Interval 3.3 to 8.2
|
5.1 months
Interval 4.2 to 5.5
|
—
|
5.7 months
Interval 4.6 to 11.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsPFS was defined as the time (in months) from the treatment start date to the first date of documented PD or death. Disease progression was defined as ≥20% increase in the SOD of target lesions taking as reference the nadir SOD (or the baseline if the baseline is the nadir value). In addition to the relative increase of 20% in SOD, the SOD must also have demonstrated an absolute increase of ≥ 5 mm.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1: Poziotinib 16 mg
Serious events: 50 serious events
Other events: 115 other events
Deaths: 16 deaths
Cohort 2: Poziotinib 16 mg
Serious events: 36 serious events
Other events: 90 other events
Deaths: 16 deaths
Cohort 3: Poziotinib, 16 mg
Serious events: 35 serious events
Other events: 80 other events
Deaths: 14 deaths
Cohort 4: Poziotinib 8 mg
Serious events: 12 serious events
Other events: 33 other events
Deaths: 6 deaths
Cohort 4: Poziotinib 16 mg
Serious events: 18 serious events
Other events: 47 other events
Deaths: 8 deaths
Cohort 5: Poziotinib 6 mg
Serious events: 13 serious events
Other events: 37 other events
Deaths: 11 deaths
Cohort 5: Poziotinib 8mg
Serious events: 38 serious events
Other events: 124 other events
Deaths: 24 deaths
Cohort 5: Poziotinib 10 mg
Serious events: 10 serious events
Other events: 35 other events
Deaths: 7 deaths
Cohort 5: Poziotinib 12 mg
Serious events: 14 serious events
Other events: 25 other events
Deaths: 14 deaths
Cohort 5: Poziotinib 16 mg
Serious events: 12 serious events
Other events: 26 other events
Deaths: 4 deaths
Cohort 6: Poziotinib 8 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Cohort 6: Poziotinib 16 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 7: Poziotinib 8 mg
Serious events: 9 serious events
Other events: 17 other events
Deaths: 6 deaths
Cohort 7: Poziotinib 16 mg
Serious events: 3 serious events
Other events: 9 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Cohort 1: Poziotinib 16 mg
n=115 participants at risk
Participants previously treated for EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 35 months, whichever occurs first.
|
Cohort 2: Poziotinib 16 mg
n=90 participants at risk
Participants previously treated for HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
|
Cohort 3: Poziotinib, 16 mg
n=80 participants at risk
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
|
Cohort 4: Poziotinib 8 mg
n=33 participants at risk
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
|
Cohort 4: Poziotinib 16 mg
n=47 participants at risk
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
|
Cohort 5: Poziotinib 6 mg
n=38 participants at risk
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 23 months, whichever occurs first.
|
Cohort 5: Poziotinib 8mg
n=125 participants at risk
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 25 months, whichever occurs first.
|
Cohort 5: Poziotinib 10 mg
n=35 participants at risk
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 10 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 15 months, whichever occurs first.
|
Cohort 5: Poziotinib 12 mg
n=25 participants at risk
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 12 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
|
Cohort 5: Poziotinib 16 mg
n=26 participants at risk
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 18 months, whichever occurs first.
|
Cohort 6: Poziotinib 8 mg
n=7 participants at risk
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
|
Cohort 6: Poziotinib 16 mg
n=1 participants at risk
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 7 months, whichever occurs first.
|
Cohort 7: Poziotinib 8 mg
n=17 participants at risk
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
|
Cohort 7: Poziotinib 16 mg
n=9 participants at risk
Participants with EGFR or HER2 activating mutations received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 4 months, whichever occurs first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
6.1%
7/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.6%
5/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.4%
3/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.4%
3/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
5/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.2%
2/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.2%
4/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.5%
4/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
3/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.8%
2/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.5%
4/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.7%
6/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.5%
2/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.5%
4/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.4%
3/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.7%
2/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
2/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.2%
2/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
2/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.4%
4/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
4/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Sepsis
|
1.7%
2/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.5%
2/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
1/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
2/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.4%
4/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.5%
2/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.6%
2/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Psychiatric disorders
Mental status changes
|
1.7%
2/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.5%
2/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.0%
2/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Vomiting
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
4/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.7%
2/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
1/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Vascular disorders
Deep vein thrombosis
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.2%
2/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Lung infection
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Cardiac disorders
Cardiac arrest
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.4%
4/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.3%
2/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.0%
2/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.5%
2/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Oedema peripheral
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.6%
2/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Pyrexia
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Vascular disorders
Hypotension
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.6%
2/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
5/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.3%
3/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.4%
3/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
5/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.3%
3/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
1.7%
2/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
2/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.4%
4/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.2%
5/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.6%
2/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
2/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
3/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.6%
2/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Seizure
|
1.7%
2/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.5%
2/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.6%
2/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Asthenia
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.3%
3/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Chest pain
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
3/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Dysarthria
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Hemiparesis
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Neutrophilic dermatosis
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Cardiac disorders
Pericardial effusion
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Eye disorders
Vision blurred
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Staphylococcal infection
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Ataxia
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Melaena
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Paraesthesia
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Sudden death
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.2%
2/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Fatigue
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.2%
2/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
1/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.3%
2/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Eye disorders
Eye pain
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Face oedema
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Vascular disorders
Haematoma
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Pain
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Vascular disorders
Superior vena cava occlusion
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
General physical health deterioration
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Vascular disorders
Embolism
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
3/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Troponin increased
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Infection
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Immune system disorders
Type III immune complex mediated reaction
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
1/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Euthanasia
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Product Issues
Device occlusion
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Transaminases increased
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Headache
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Gastroenteritis radiation
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Coronavirus test positive
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.3%
2/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Tremor
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Ascites
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Coccidioidomycosis
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Pleural infection
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Death
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Vascular disorders
Distributive shock
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
Other adverse events
| Measure |
Cohort 1: Poziotinib 16 mg
n=115 participants at risk
Participants previously treated for EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 35 months, whichever occurs first.
|
Cohort 2: Poziotinib 16 mg
n=90 participants at risk
Participants previously treated for HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
|
Cohort 3: Poziotinib, 16 mg
n=80 participants at risk
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
|
Cohort 4: Poziotinib 8 mg
n=33 participants at risk
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
|
Cohort 4: Poziotinib 16 mg
n=47 participants at risk
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
|
Cohort 5: Poziotinib 6 mg
n=38 participants at risk
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 23 months, whichever occurs first.
|
Cohort 5: Poziotinib 8mg
n=125 participants at risk
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 25 months, whichever occurs first.
|
Cohort 5: Poziotinib 10 mg
n=35 participants at risk
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 10 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 15 months, whichever occurs first.
|
Cohort 5: Poziotinib 12 mg
n=25 participants at risk
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 12 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
|
Cohort 5: Poziotinib 16 mg
n=26 participants at risk
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 18 months, whichever occurs first.
|
Cohort 6: Poziotinib 8 mg
n=7 participants at risk
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
|
Cohort 6: Poziotinib 16 mg
n=1 participants at risk
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 7 months, whichever occurs first.
|
Cohort 7: Poziotinib 8 mg
n=17 participants at risk
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
|
Cohort 7: Poziotinib 16 mg
n=9 participants at risk
Participants with EGFR or HER2 activating mutations received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 4 months, whichever occurs first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
81.7%
94/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
83.3%
75/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
87.5%
70/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
87.9%
29/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
83.0%
39/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
84.2%
32/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
88.8%
111/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
82.9%
29/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
88.0%
22/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
84.6%
22/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
71.4%
5/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
100.0%
17/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
77.8%
7/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Stomatitis
|
72.2%
83/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
66.7%
60/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
80.0%
64/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
72.7%
24/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
80.9%
38/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
68.4%
26/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
76.8%
96/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
65.7%
23/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
72.0%
18/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
50.0%
13/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
71.4%
5/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
58.8%
10/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
66.7%
6/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Rash
|
61.7%
71/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
68.9%
62/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
63.7%
51/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
51.5%
17/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
74.5%
35/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
63.2%
24/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
60.0%
75/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
68.6%
24/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
84.0%
21/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
61.5%
16/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
28.6%
2/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
100.0%
1/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
41.2%
7/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
66.7%
6/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Paronychia
|
49.6%
57/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
42.2%
38/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
66.2%
53/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
63.6%
21/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
51.1%
24/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
44.7%
17/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
48.0%
60/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
45.7%
16/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
72.0%
18/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
46.2%
12/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
1/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
17.6%
3/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
22.2%
2/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Nausea
|
48.7%
56/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
38.9%
35/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
41.2%
33/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
42.4%
14/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
27.7%
13/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
18.4%
7/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
36.0%
45/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
31.4%
11/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
28.0%
7/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
26.9%
7/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
1/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
35.3%
6/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.4%
43/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
40.0%
36/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
41.2%
33/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
54.5%
18/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
31.9%
15/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
18.4%
7/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
45.6%
57/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
20.0%
7/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
24.0%
6/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
26.9%
7/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
1/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
35.3%
6/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
3/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Vomiting
|
37.4%
43/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
31.1%
28/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
31.2%
25/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
30.3%
10/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
17.0%
8/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
18.4%
7/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
31.2%
39/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
28.6%
10/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
40.0%
10/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
19.2%
5/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
1/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
29.4%
5/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
22.2%
2/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Fatigue
|
34.8%
40/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
32.2%
29/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
43.8%
35/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
54.5%
18/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
36.2%
17/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
39.5%
15/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
48.8%
61/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
22.9%
8/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
56.0%
14/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
19.2%
5/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
28.6%
2/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
41.2%
7/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
30.4%
35/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
35.6%
32/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
37.5%
30/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
42.4%
14/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
38.3%
18/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
28.8%
36/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
20.0%
7/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
28.0%
7/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
23.1%
6/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
1/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
17.6%
3/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
29.6%
34/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
30/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
42.5%
34/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
11/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
36.2%
17/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
34.2%
13/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
30.4%
38/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
37.1%
13/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
36.0%
9/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
42.3%
11/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
28.6%
2/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
23.5%
4/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Weight decreased
|
28.7%
33/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
21.1%
19/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
18.8%
15/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
30.3%
10/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
29.8%
14/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
23.7%
9/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
25.6%
32/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
25.7%
9/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
36.0%
9/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
30.8%
8/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.8%
2/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
22.2%
2/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
26.1%
30/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
17.8%
16/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
28.7%
23/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
15.2%
5/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
27.7%
13/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
18.4%
7/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
21.6%
27/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
25.7%
9/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.5%
3/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
28.6%
2/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
17.6%
3/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Vascular disorders
Hypertension
|
8.7%
10/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.2%
5/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
9.1%
3/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.8%
6/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.4%
4/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
16.0%
4/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
26.1%
30/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
22.2%
20/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
26.2%
21/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
18.2%
6/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
23.4%
11/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
13.2%
5/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.8%
16/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
17.1%
6/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
36.0%
9/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
19.2%
5/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.1%
30/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
26.7%
24/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
27.5%
22/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
30.3%
10/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
19.1%
9/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
23.7%
9/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
22.9%
8/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
48.0%
12/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
19.2%
5/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
1/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
23.5%
4/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
22.2%
2/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Dehydration
|
18.3%
21/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.6%
5/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.5%
6/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
9.1%
3/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.4%
3/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.3%
2/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.6%
7/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.6%
3/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Constipation
|
18.3%
21/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
15.6%
14/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
25.0%
20/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
24.2%
8/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
17.0%
8/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
15.8%
6/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
13.6%
17/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
17.1%
6/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
19.2%
5/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Blood and lymphatic system disorders
Anaemia
|
17.4%
20/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
23.3%
21/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.8%
7/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
9.1%
3/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.6%
5/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
17.6%
22/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.7%
2/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
15.4%
4/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
28.6%
2/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
17.6%
3/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.4%
20/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
17.8%
16/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
17.5%
14/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
27.3%
9/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
19.1%
9/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
15.8%
6/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
18.4%
23/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
17.1%
6/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.5%
3/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
1/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
17.4%
20/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
13.3%
12/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.0%
8/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.6%
5/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
20.0%
25/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
22.9%
8/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
20.0%
5/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
15.4%
4/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
1/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.8%
2/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.7%
18/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
20.0%
18/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
30.0%
24/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.1%
4/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
17.0%
8/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
13.2%
5/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
17.1%
6/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Oedema peripheral
|
15.7%
18/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
15.6%
14/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
26.2%
21/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
18.2%
6/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.9%
7/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.3%
2/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.4%
18/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
5/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
23.1%
6/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
15.7%
18/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.0%
9/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
15.0%
12/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
24.2%
8/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.8%
6/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
15.8%
6/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
17.1%
6/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.8%
17/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
10/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.2%
9/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.1%
4/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.6%
5/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.6%
7/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
19.2%
5/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
1/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.9%
16/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.8%
7/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.0%
8/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.1%
4/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.4%
3/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.9%
3/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.6%
3/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
1/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.9%
16/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
17.8%
16/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
21.2%
17/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
27.3%
9/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
19.1%
9/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.5%
4/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
15.2%
19/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.4%
4/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
24.0%
6/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.5%
3/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.8%
2/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Dysgeusia
|
13.0%
15/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.9%
8/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
23.8%
19/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
36.4%
12/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
19.1%
9/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.9%
3/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
22.4%
28/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
22.9%
8/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.7%
2/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
23.5%
4/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
22.2%
2/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Dizziness
|
12.2%
14/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
17.8%
16/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
16.2%
13/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
18.2%
6/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
21.3%
10/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
13.2%
5/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
20.0%
7/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.7%
2/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
12.2%
14/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.9%
8/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.5%
6/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.1%
2/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.3%
2/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.5%
4/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.0%
15/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.4%
4/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.7%
2/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.3%
13/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
22.2%
20/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
13.8%
11/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
21.2%
7/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.8%
6/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.5%
4/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
13.6%
17/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.7%
2/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
20.0%
5/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.5%
3/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Headache
|
10.4%
12/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.9%
8/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
13.8%
11/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.1%
2/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.3%
2/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.5%
4/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.7%
2/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.0%
3/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
9.6%
11/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.6%
7/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.7%
2/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.7%
10/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.8%
7/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.2%
9/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.1%
2/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.3%
2/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.2%
14/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.6%
3/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
24.0%
6/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.7%
2/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
23.5%
4/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Pyrexia
|
8.7%
10/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.7%
6/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.5%
10/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.4%
3/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
15.8%
6/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.2%
9/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.6%
3/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.0%
3/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.5%
3/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
28.6%
2/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.7%
10/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.6%
5/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.5%
6/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.1%
2/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.9%
3/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.7%
2/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
16.0%
4/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
1/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Psychiatric disorders
Insomnia
|
8.7%
10/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.8%
7/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
16.2%
13/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
9.1%
3/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.4%
13/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
8.7%
10/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.0%
9/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
16.2%
13/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
24.2%
8/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
19.1%
9/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
31.6%
12/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
19.2%
24/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
5/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
32.0%
8/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.7%
2/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
22.2%
2/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Urinary tract infection
|
8.7%
10/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.5%
6/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.1%
2/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.3%
2/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.3%
2/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.7%
2/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.0%
3/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.8%
9/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.9%
8/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.2%
9/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.1%
4/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.3%
2/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
9.6%
12/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
20.0%
5/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.7%
2/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
9/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.8%
7/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.8%
7/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.5%
4/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.8%
6/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.7%
2/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Eye disorders
Vision blurred
|
7.8%
9/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.5%
6/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
9.1%
3/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.0%
3/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Eye disorders
Dry eye
|
7.8%
9/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.9%
8/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
20.0%
16/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
15.2%
5/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.6%
5/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
15.8%
6/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.8%
16/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.4%
4/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
16.0%
4/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
28.6%
2/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.8%
9/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.9%
8/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.8%
7/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
18.2%
6/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.4%
3/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
13.6%
17/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.5%
3/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.8%
9/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.6%
5/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.8%
7/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.6%
7/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Pain
|
7.8%
9/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.0%
8/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.6%
7/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.5%
4/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.4%
4/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
4/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.0%
8/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.9%
8/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.5%
6/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.6%
7/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.0%
8/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.8%
7/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.5%
6/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.1%
2/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.2%
4/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.7%
2/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.0%
2/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.7%
2/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Injury, poisoning and procedural complications
Fall
|
7.0%
8/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.2%
5/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
16.0%
4/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Dry mouth
|
7.0%
8/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.4%
4/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
20.0%
16/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
27.3%
9/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.9%
7/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.9%
3/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
16.8%
21/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.7%
2/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.0%
2/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
15.4%
4/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.8%
2/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.0%
8/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.9%
8/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.2%
5/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
16.8%
21/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
6.1%
7/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.5%
2/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.1%
4/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.8%
11/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
6.1%
7/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.1%
2/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.3%
2/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.4%
3/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Alanine aminotransferase increased
|
6.1%
7/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.8%
7/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
13.8%
11/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
21.2%
7/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.0%
15/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.0%
2/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.5%
3/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
23.5%
4/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Asthenia
|
6.1%
7/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.7%
6/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
9.1%
3/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
3/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Chest pain
|
6.1%
7/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.6%
5/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.8%
7/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.1%
4/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.6%
7/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Aspartate aminotransferase increased
|
6.1%
7/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.3%
3/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.2%
5/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.1%
4/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.4%
3/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.8%
16/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.6%
3/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.5%
3/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.8%
2/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Chills
|
6.1%
7/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.9%
8/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.2%
5/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
15.2%
5/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
15.8%
6/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.0%
10/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.0%
3/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
1/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.1%
7/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.2%
2/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
3/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.3%
2/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.6%
7/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.7%
2/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.2%
6/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
3/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.4%
3/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Blood creatinine increased
|
5.2%
6/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.7%
6/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.2%
5/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.1%
2/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.3%
2/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.6%
7/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.6%
3/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.0%
3/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.7%
2/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
23.5%
4/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.2%
6/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.7%
6/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.2%
5/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.1%
2/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.6%
7/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.7%
2/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Psychiatric disorders
Depression
|
5.2%
6/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.7%
6/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
4/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
5/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Dysphagia
|
5.2%
6/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.2%
5/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
15.2%
5/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.6%
5/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.6%
7/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Eye disorders
Lacrimation increased
|
5.2%
6/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.5%
2/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
9.1%
3/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.8%
6/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.2%
4/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.2%
6/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.8%
7/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.5%
6/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.8%
6/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.5%
4/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.6%
2/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.0%
2/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.3%
3/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.1%
2/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.6%
5/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.3%
5/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.7%
6/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.0%
8/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.1%
4/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Pneumonia
|
6.1%
7/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.8%
7/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.2%
5/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.5%
4/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.4%
3/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.7%
2/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
11.1%
1/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Lymphocyte count decreased
|
4.3%
5/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.2%
1/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.6%
5/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.6%
2/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Folliculitis
|
3.5%
4/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.3%
3/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
4/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.5%
4/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
1/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Psychiatric disorders
Anxiety
|
4.3%
5/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.4%
4/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
4/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.1%
2/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.3%
2/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.4%
3/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.7%
2/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
4/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.0%
1/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.7%
2/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
4/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Non-cardiac chest pain
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
4/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.3%
5/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
4/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.4%
4/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
4/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.5%
4/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
2/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.2%
2/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
12.1%
4/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.4%
3/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.9%
3/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
5/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.6%
3/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.7%
2/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Blood urea increased
|
0.00%
0/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.1%
2/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.4%
3/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.6%
2/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
2.6%
3/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
1.1%
1/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
3/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.1%
2/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.4%
3/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.9%
3/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.2%
4/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.6%
3/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Rhinitis
|
4.3%
5/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.5%
2/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
6.1%
2/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
7.9%
3/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.2%
4/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.7%
2/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.0%
2/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Oral pain
|
4.3%
5/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.2%
2/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.5%
2/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.6%
7/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
8.0%
2/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.87%
1/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
4/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Cardiac disorders
Sinus tachycardia
|
4.3%
5/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.2%
2/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.7%
2/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
14.3%
1/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Fungal infection
|
4.3%
5/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.2%
2/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.1%
1/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.6%
1/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
2.9%
1/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.8%
1/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Renal and urinary disorders
Haematuria
|
1.7%
2/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
3.3%
3/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
5.9%
1/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.3%
5/115 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/90 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/80 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/33 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
10.6%
5/47 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/38 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.80%
1/125 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/35 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
4.0%
1/25 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/26 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/7 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/1 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/17 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/9 • Up to 5 years
Safety Population included all participants who signed Informed Consent, enrolled, and received at least 1 dose of poziotinib.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place