Trial Outcomes & Findings for Study of Poziotinib in Japanese Patients With NSCLC (NCT NCT04402008)
NCT ID: NCT04402008
Last Updated: 2024-06-25
Results Overview
DLT was any of the following treatment-related adverse events occurring during Cycle 1, Non-Hematological Toxicity: Grade 3 or higher toxicity except for alopecia; Grade 3 or higher nausea, vomiting, and diarrhea despite medical intervention. Hematological Toxicity: Grade 4 or higher neutropenia for ≥7 days; Febrile neutropenia with a single temperature of \>38.3°C or a sustained temperature of ≥38°C; Neutropenic infection: Grade 3 or higher infection accompanying Grade 4 neutropenia; Grade 4 thrombocytopenia or any grade thrombocytopenia requiring platelet transfusion.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Cycle 1 (Day 1-28)
Results posted on
2024-06-25
Participant Flow
A total of 42 participants were enrolled at multiple investigative sites in Japan from 23 Jun 2020 to 15 Feb 2023.
Participants took part in Phase 1 (Dose Escalation) and Phase 2 (Efficacy) of the study. Phase 2 was terminated early.
Participant milestones
| Measure |
Phase 1: Poziotinib 8 mg QD
Participants received poziotinib 8 milligrams (mg) orally, once daily (QD) in each 28-day treatment cycle.
|
Phase 1: Poziotinib 12 mg QD
Participants received poziotinib 12 mg orally, QD in each 28-day treatment cycle.
|
Phase 1: Poziotinib 16 mg QD
Participants received poziotinib 16 mg orally, QD in each 28-day treatment cycle.
|
Phase 1: Poziotinib 4 mg BID
Participants received poziotinib 4 mg orally, twice daily (BID) in each 28-day treatment cycle.
|
Phase 1: Poziotinib 6 mg BID
Participants received poziotinib 6 mg orally, BID in each 28-day treatment cycle.
|
Phase 1: Poziotinib 8 mg BID
Participants received poziotinib 8 mg orally, BID in each 28-day treatment cycle.
|
Phase 2: Poziotinib 12 mg QD
Participants received poziotinib 12 mg orally, QD in each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
4
|
6
|
3
|
20
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
4
|
6
|
3
|
20
|
Reasons for withdrawal
| Measure |
Phase 1: Poziotinib 8 mg QD
Participants received poziotinib 8 milligrams (mg) orally, once daily (QD) in each 28-day treatment cycle.
|
Phase 1: Poziotinib 12 mg QD
Participants received poziotinib 12 mg orally, QD in each 28-day treatment cycle.
|
Phase 1: Poziotinib 16 mg QD
Participants received poziotinib 16 mg orally, QD in each 28-day treatment cycle.
|
Phase 1: Poziotinib 4 mg BID
Participants received poziotinib 4 mg orally, twice daily (BID) in each 28-day treatment cycle.
|
Phase 1: Poziotinib 6 mg BID
Participants received poziotinib 6 mg orally, BID in each 28-day treatment cycle.
|
Phase 1: Poziotinib 8 mg BID
Participants received poziotinib 8 mg orally, BID in each 28-day treatment cycle.
|
Phase 2: Poziotinib 12 mg QD
Participants received poziotinib 12 mg orally, QD in each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Disease Progression
|
3
|
2
|
3
|
3
|
4
|
3
|
10
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
Baseline Characteristics
Study of Poziotinib in Japanese Patients With NSCLC
Baseline characteristics by cohort
| Measure |
Phase 1: Poziotinib 8 mg QD
n=3 Participants
Participants received poziotinib 8 mg orally, QD in each 28-day treatment cycle.
|
Phase 1: Poziotinib 12 mg QD
n=3 Participants
Participants received poziotinib 12 mg orally, QD in each 28-day treatment cycle.
|
Phase 1: Poziotinib 16 mg QD
n=3 Participants
Participants received poziotinib 16 mg orally, QD in each 28-day treatment cycle.
|
Phase 1:Poziotinib 4 mg BID
n=4 Participants
Participants received poziotinib 4 mg orally, BID in each 28-day treatment cycle.
|
Phase 1: Poziotinib 6 mg BID
n=6 Participants
Participants received poziotinib 6 mg orally, BID in each 28-day treatment cycle.
|
Phase 1: Poziotinib 8 mg BID
n=3 Participants
Participants received poziotinib 8 mg orally, BID in each 28-day treatment cycle.
|
Phase 2: Poziotinib 12 mg QD
n=20 Participants
Participants received poziotinib 12 mg orally, QD in each 28-day treatment cycle.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 15.01 • n=39 Participants
|
58.7 years
STANDARD_DEVIATION 12.86 • n=41 Participants
|
65.3 years
STANDARD_DEVIATION 17.79 • n=35 Participants
|
57.8 years
STANDARD_DEVIATION 15.26 • n=31 Participants
|
60.3 years
STANDARD_DEVIATION 15.58 • n=146 Participants
|
52.0 years
STANDARD_DEVIATION 20.07 • n=19 Participants
|
60.9 years
STANDARD_DEVIATION 10.36 • n=147 Participants
|
60.1 years
STANDARD_DEVIATION 12.59 • n=193 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
3 Participants
n=19 Participants
|
14 Participants
n=147 Participants
|
22 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
6 Participants
n=147 Participants
|
20 Participants
n=193 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
6 Participants
n=146 Participants
|
3 Participants
n=19 Participants
|
20 Participants
n=147 Participants
|
42 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
00 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic/ Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic/ Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Japanese
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
6 Participants
n=146 Participants
|
3 Participants
n=19 Participants
|
20 Participants
n=147 Participants
|
42 Participants
n=193 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Day 1-28)Population: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
DLT was any of the following treatment-related adverse events occurring during Cycle 1, Non-Hematological Toxicity: Grade 3 or higher toxicity except for alopecia; Grade 3 or higher nausea, vomiting, and diarrhea despite medical intervention. Hematological Toxicity: Grade 4 or higher neutropenia for ≥7 days; Febrile neutropenia with a single temperature of \>38.3°C or a sustained temperature of ≥38°C; Neutropenic infection: Grade 3 or higher infection accompanying Grade 4 neutropenia; Grade 4 thrombocytopenia or any grade thrombocytopenia requiring platelet transfusion.
Outcome measures
| Measure |
Phase 1: Poziotinib 8 mg QD
n=3 Participants
Participants received poziotinib 8 mg orally, QD in each 28-day treatment cycle.
|
Phase 1: Poziotinib 12 mg QD
n=3 Participants
Participants received poziotinib 12 mg orally, QD in each 28-day treatment cycle.
|
Phase 1: Poziotinib 16 mg QD
n=3 Participants
Participants received poziotinib 16 mg orally, QD in each 28-day treatment cycle.
|
Phase 1: Poziotinib 4 mg BID
n=4 Participants
Participants received poziotinib 4 mg orally, BID in each 28-day treatment cycle.
|
Phase 1: Poziotinib 6 mg BID
n=6 Participants
Participants received poziotinib 6 mg orally, BID in each 28-day treatment cycle.
|
Phase 1: Poziotinib 8 mg BID
n=3 Participants
Participants received poziotinib 8 mg orally, BID in each 28-day treatment cycle.
|
Phase 2: Poziotinib 12 mg QD
Participants received poziotinib 12 mg orally, QD in each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 461 daysPopulation: Data for this outcome measure was not collected and analyzed as planned as the study was terminated due to the sponsor's business decision.
ORR was defined as the percentage of participants with best response i.e confirmed complete response (CR) and partial response (PR) as assessed by the investigator using local radiology evaluation according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to \<10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 461 daysPopulation: Data for this outcome measure was not collected and analyzed as planned as the study was terminated due to the sponsor's business decision.
The percentage of participants who achieve CR, PR, and stable disease (SD) by the best response from the first dose of poziotinib to the end of the study as assessed by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 461 daysPopulation: Data for this outcome measure was not collected and analyzed as planned as the study was terminated due to the sponsor's business decision.
Duration of response was defined as the time from the date that measurement criteria are first met for CR or PR until the first subsequent date that progressive disease as assessed by the investigator according to RECIST v1.1 or death is documented. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 461 daysPopulation: Data for this outcome measure was not collected and analyzed as planned as the study was terminated due to the sponsor's business decision.
PFS was the number of days from the treatment start date to the date of first documented disease progression or death from any cause. Per RECIST v1.1 for target lesions, PD was defined as ≥20% increase in sum of diameters (SOD) from previous smallest SOD on study, and an absolute increase of ≥5mm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1, Day 1 and Day 13Population: Data for this outcome measure was not collected and analyzed as planned as the study was terminated due to the sponsor's business decision.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 40 days after the last dose of the study drug (Up to 461 days)Population: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
TEAEs are AEs that occur from the first dose of study treatment until 40 days after the last dose of study treatment. An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Outcome measures
| Measure |
Phase 1: Poziotinib 8 mg QD
n=3 Participants
Participants received poziotinib 8 mg orally, QD in each 28-day treatment cycle.
|
Phase 1: Poziotinib 12 mg QD
n=3 Participants
Participants received poziotinib 12 mg orally, QD in each 28-day treatment cycle.
|
Phase 1: Poziotinib 16 mg QD
n=3 Participants
Participants received poziotinib 16 mg orally, QD in each 28-day treatment cycle.
|
Phase 1: Poziotinib 4 mg BID
n=4 Participants
Participants received poziotinib 4 mg orally, BID in each 28-day treatment cycle.
|
Phase 1: Poziotinib 6 mg BID
n=6 Participants
Participants received poziotinib 6 mg orally, BID in each 28-day treatment cycle.
|
Phase 1: Poziotinib 8 mg BID
n=3 Participants
Participants received poziotinib 8 mg orally, BID in each 28-day treatment cycle.
|
Phase 2: Poziotinib 12 mg QD
n=20 Participants
Participants received poziotinib 12 mg orally, QD in each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|
|
Phase 1 and 2: Percentage of Participants With Treatment Emergent Adverse Events (TEAE)
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsThe number of days from the treatment start date to the date of death due to any cause.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1: Poziotinib 8 mg QD
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1: Poziotinib 12 mg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1: Poziotinib 16 mg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1: Poziotinib 4 mg BID
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
Phase 1: Poziotinib 6 mg BID
Serious events: 1 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 1: Poziotinib 8 mg BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 2: Poziotinib 12mg QD
Serious events: 4 serious events
Other events: 20 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Phase 1: Poziotinib 8 mg QD
n=3 participants at risk
Participants received poziotinib 8 mg orally, QD, in each 28-day treatment cycle.
|
Phase 1: Poziotinib 12 mg QD
n=3 participants at risk
Participants received poziotinib 12 mg orally, QD, in each 28-day treatment cycle.
|
Phase 1: Poziotinib 16 mg QD
n=3 participants at risk
Participants received poziotinib 16 mg orally, QD, in each 28-day treatment cycle.
|
Phase 1: Poziotinib 4 mg BID
n=4 participants at risk
Participants received poziotinib 4 mg orally, BID, in each 28-day treatment cycle.
|
Phase 1: Poziotinib 6 mg BID
n=6 participants at risk
Participants received poziotinib 6 mg orally, BID, in each 28-day treatment cycle.
|
Phase 1: Poziotinib 8 mg BID
n=3 participants at risk
Participants received poziotinib 8 mg orally, BID, in each 28-day treatment cycle.
|
Phase 2: Poziotinib 12mg QD
n=20 participants at risk
Participants received poziotinib 12 mg orally, QD, in each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|
|
Investigations
Amylase increased
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
25.0%
1/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: 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%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
16.7%
1/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Seizure
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Renal and urinary disorders
Urethritis
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: 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%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
Other adverse events
| Measure |
Phase 1: Poziotinib 8 mg QD
n=3 participants at risk
Participants received poziotinib 8 mg orally, QD, in each 28-day treatment cycle.
|
Phase 1: Poziotinib 12 mg QD
n=3 participants at risk
Participants received poziotinib 12 mg orally, QD, in each 28-day treatment cycle.
|
Phase 1: Poziotinib 16 mg QD
n=3 participants at risk
Participants received poziotinib 16 mg orally, QD, in each 28-day treatment cycle.
|
Phase 1: Poziotinib 4 mg BID
n=4 participants at risk
Participants received poziotinib 4 mg orally, BID, in each 28-day treatment cycle.
|
Phase 1: Poziotinib 6 mg BID
n=6 participants at risk
Participants received poziotinib 6 mg orally, BID, in each 28-day treatment cycle.
|
Phase 1: Poziotinib 8 mg BID
n=3 participants at risk
Participants received poziotinib 8 mg orally, BID, in each 28-day treatment cycle.
|
Phase 2: Poziotinib 12mg QD
n=20 participants at risk
Participants received poziotinib 12 mg orally, QD, in each 28-day treatment cycle.
|
|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
66.7%
2/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
20.0%
4/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Angular Cheilitis
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
50.0%
2/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
16.7%
1/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
10.0%
2/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
25.0%
1/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
16.7%
1/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
15.0%
3/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
25.0%
1/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
15.0%
3/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Blood corticotrophin decreased
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
25.0%
1/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
16.7%
1/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
15.0%
3/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Malaise
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
50.0%
2/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
15.0%
3/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
25.0%
1/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
100.0%
3/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
66.7%
2/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
50.0%
2/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
83.3%
5/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
100.0%
3/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
85.0%
17/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
100.0%
3/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
100.0%
3/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
50.0%
2/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
66.7%
4/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
100.0%
3/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
55.0%
11/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Paronychia
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
66.7%
2/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
75.0%
3/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
50.0%
3/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
66.7%
2/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
70.0%
14/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: 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
|
66.7%
2/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
66.7%
2/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
100.0%
3/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
75.0%
3/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
66.7%
4/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
50.0%
10/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: 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
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
66.7%
2/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
50.0%
2/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
16.7%
1/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
66.7%
2/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
25.0%
5/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
100.0%
3/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
35.0%
7/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Eye disorders
Blepharitis
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
25.0%
1/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
16.7%
1/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
20.0%
4/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: 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
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
75.0%
3/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
2/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
10.0%
2/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
2/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
15.0%
3/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
10.0%
2/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
10.0%
2/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
25.0%
1/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
16.7%
1/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
16.7%
1/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
15.0%
3/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
20.0%
4/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Eye disorders
Conjunctivitis
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
2/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
15.0%
3/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
16.7%
1/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
25.0%
1/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
General disorders
Mucosal inflammation
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
10.0%
2/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
10.0%
2/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
16.7%
1/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: 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
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Skin infection
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
16.7%
1/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: 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%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
16.7%
1/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: 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
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: 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)
Cancer pain
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
Cortisol decreased
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Vascular disorders
Dependent rubor
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Eye disorders
Eye discharge
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: 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%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
16.7%
1/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
25.0%
1/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
16.7%
1/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
16.7%
1/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Impetigo
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: 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
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Pharyngitis
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Blood and lymphatic system disorders
Purpura
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
33.3%
1/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/4 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/6 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
0.00%
0/3 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: Safety population included all participants who signed informed consent, enrolled, and received at least 1 dose of poziotinib.
|
5.0%
1/20 • Up to 40 days after the last dose of the study drug (Up to 461 days)
All-cause mortality and AEs: 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