Trial Outcomes & Findings for A Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib (NCT NCT03744715)

NCT ID: NCT03744715

Last Updated: 2026-07-28

Results Overview

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Up to 18 months

Results posted on

2026-07-28

Participant Flow

Participants were enrolled at investigative sites across the United States from 11 October 2018 to 03 March 2023.

A total of 7 participants were enrolled and dosed with Poziotinib.

Participant milestones

Participant milestones
Measure
Poziotinib 6 mg
Participants started poziotinib 6 mg twice a day (BID) in a 21-day cycle in the current study after having received 16 mg once daily (QD) in the parent study NCT03318939.
Poziotinib 8 mg
Participants started poziotinib 8 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.
Poziotinib 12 mg
Participants started poziotinib 12 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT03318939.
Poziotinib 14 mg
Participants started poziotinib 14 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.
Poziotinib 16 mg
Participants started poziotinib at 16 mg QD in a 21-day cycle in the current study after having received 12 mg QD in the parent study NCT03804515.
Poziotinib 24 mg
Participants started poziotinib at 24 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT02659514.
Overall Study
STARTED
1
1
1
1
2
1
Overall Study
COMPLETED
0
0
0
0
0
0
Overall Study
NOT COMPLETED
1
1
1
1
2
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Poziotinib 6 mg
Participants started poziotinib 6 mg twice a day (BID) in a 21-day cycle in the current study after having received 16 mg once daily (QD) in the parent study NCT03318939.
Poziotinib 8 mg
Participants started poziotinib 8 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.
Poziotinib 12 mg
Participants started poziotinib 12 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT03318939.
Poziotinib 14 mg
Participants started poziotinib 14 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.
Poziotinib 16 mg
Participants started poziotinib at 16 mg QD in a 21-day cycle in the current study after having received 12 mg QD in the parent study NCT03804515.
Poziotinib 24 mg
Participants started poziotinib at 24 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT02659514.
Overall Study
Adverse Event
0
0
0
0
1
0
Overall Study
Withdrawal by Subject
0
0
0
1
0
0
Overall Study
Disease progression
0
1
0
0
1
1
Overall Study
Study terminated by sponsor
1
0
0
0
0
0
Overall Study
Initiation of another anti-malignancy therapy
0
0
1
0
0
0

Baseline Characteristics

A Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Poziotinib 16 mg
n=2 Participants
Participants started poziotinib at 16 mg QD in a 21-day cycle in the current study after having received 12 mg QD in the parent study NCT03804515.
Poziotinib 24 mg
n=1 Participants
Participants started poziotinib at 24 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT02659514.
Total
n=7 Participants
Total of all reporting groups
Poziotinib 14 mg
n=1 Participants
Participants started poziotinib 14 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939
Poziotinib 6 mg
n=1 Participants
Participants started poziotinib 6 mg BID in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.
Poziotinib 8 mg
n=1 Participants
Participants started poziotinib 8 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.
Poziotinib 12 mg
n=1 Participants
Participants started poziotinib 12 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT03318939.
Age, Categorical
<=18 years
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=9 Participants
1 Participants
n=6 Participants
4 Participants
n=6 Participants
1 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Age, Categorical
>=65 years
0 Participants
n=9 Participants
0 Participants
n=6 Participants
3 Participants
n=6 Participants
0 Participants
n=5 Participants
1 Participants
n=20 Participants
1 Participants
n=20 Participants
1 Participants
n=40 Participants
Sex: Female, Male
Female
1 Participants
n=9 Participants
1 Participants
n=6 Participants
4 Participants
n=6 Participants
0 Participants
n=5 Participants
0 Participants
n=20 Participants
1 Participants
n=20 Participants
1 Participants
n=40 Participants
Sex: Female, Male
Male
1 Participants
n=9 Participants
0 Participants
n=6 Participants
3 Participants
n=6 Participants
1 Participants
n=5 Participants
1 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=9 Participants
1 Participants
n=6 Participants
7 Participants
n=6 Participants
1 Participants
n=5 Participants
1 Participants
n=20 Participants
1 Participants
n=20 Participants
1 Participants
n=40 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Race (NIH/OMB)
Asian
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Race (NIH/OMB)
White
2 Participants
n=9 Participants
1 Participants
n=6 Participants
3 Participants
n=6 Participants
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=9 Participants
0 Participants
n=6 Participants
4 Participants
n=6 Participants
1 Participants
n=5 Participants
1 Participants
n=20 Participants
1 Participants
n=20 Participants
1 Participants
n=40 Participants
Region of Enrollment
United States
2 Participants
n=9 Participants
1 Participants
n=6 Participants
7 Participants
n=6 Participants
1 Participants
n=5 Participants
1 Participants
n=20 Participants
1 Participants
n=20 Participants
1 Participants
n=40 Participants

PRIMARY outcome

Timeframe: Up to 18 months

Population: The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Outcome measures

Outcome measures
Measure
Poziotinib 12 mg
n=1 Participants
Participants started poziotinib 12 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT03318939.
Poziotinib 14 mg
n=1 Participants
Participants started poziotinib 14 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939
Poziotinib 8 mg
n=1 Participants
Participants started poziotinib 8 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.
Poziotinib 6 mg
n=1 Participants
Participants started poziotinib 6 mg BID in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.
Poziotinib 16 mg
n=2 Participants
Participants started poziotinib at 16 mg QD in a 21-day cycle in the current study after having received 12 mg QD in the parent study NCT03804515.
Poziotinib 24 mg
n=1 Participants
Participants started poziotinib at 24 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT02659514.
Number of Participants With Adverse Events (AEs)
1 Participants
1 Participants
1 Participants
1 Participants
2 Participants
1 Participants

SECONDARY outcome

Timeframe: Up to 17 months

Population: The secondary outcome measure of ORR required multiple and sequential radiographic measures of disease (IE: RECIST). Since the study was terminated early, sequential radiographic imaging was not completed, and sufficient radiographic imaging was not available for analysis. Therefore, this outcome measure cannot be calculated.

ORR was defined as the percentage of participants with 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 17 months

Population: The secondary outcome measure of DCR required multiple and sequential radiographic measures of disease (IE: RECIST). Since the study was terminated early, sequential radiographic imaging was not completed, and sufficient radiographic imaging was not available for analysis. Therefore, this outcome measure cannot be calculated.

DCR is defined as percentage of participants with best response of CR, PR, and stable disease (SD) from the first dose of poziotinib to the end of study. CR is defined as 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 17 months

Population: The secondary outcome measure of DOR required multiple and sequential radiographic measures of disease (IE: RECIST). Since the study was terminated early, sequential radiographic imaging was not completed, and sufficient radiographic imaging was not available for analysis. Therefore, this outcome measure cannot be calculated.

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 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 17 months

Population: The secondary outcome measure of PFS required multiple and sequential radiographic measures of disease (IE: RECIST). Since the study was terminated early, sequential radiographic imaging was not completed, and sufficient radiographic imaging was not available for analysis. Therefore, this outcome measure cannot be calculated.

PFS was the duration of time from first administration of study treatment to 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 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

Adverse Events

Poziotinib 6 mg

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Poziotinib 8 mg

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Poziotinib 12 mg

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Poziotinib 14 mg

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Poziotinib 16 mg

Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths

Poziotinib 24 mg

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Poziotinib 6 mg
n=1 participants at risk
Participants started poziotinib 6 mg BID in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.
Poziotinib 8 mg
n=1 participants at risk
Participants started poziotinib 8 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.
Poziotinib 12 mg
n=1 participants at risk
Participants started poziotinib 12 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT03318939.
Poziotinib 14 mg
n=1 participants at risk
Participants started poziotinib 14 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.
Poziotinib 16 mg
n=2 participants at risk
Participants started poziotinib at 16 mg QD in a 21-day cycle in the current study after having received 12 mg QD in the parent study NCT03804515.
Poziotinib 24 mg
n=1 participants at risk
Participants started poziotinib at 24 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT02659514.
Renal and urinary disorders
Nephrolithiasis
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Gastrointestinal disorders
Pancreatitis
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Metabolism and nutrition disorders
Dehydration
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Gastrointestinal disorders
Ascites
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.

Other adverse events

Other adverse events
Measure
Poziotinib 6 mg
n=1 participants at risk
Participants started poziotinib 6 mg BID in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.
Poziotinib 8 mg
n=1 participants at risk
Participants started poziotinib 8 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.
Poziotinib 12 mg
n=1 participants at risk
Participants started poziotinib 12 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT03318939.
Poziotinib 14 mg
n=1 participants at risk
Participants started poziotinib 14 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.
Poziotinib 16 mg
n=2 participants at risk
Participants started poziotinib at 16 mg QD in a 21-day cycle in the current study after having received 12 mg QD in the parent study NCT03804515.
Poziotinib 24 mg
n=1 participants at risk
Participants started poziotinib at 24 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT02659514.
General disorders
Asthenia
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
2/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Blood and lymphatic system disorders
Anaemia
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Renal and urinary disorders
Hematuria
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Gastrointestinal disorders
Abdominal pain
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Metabolism and nutrition disorders
Dehydration
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Nervous system disorders
Dizziness
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
General disorders
Fatigue
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
2/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Vascular disorders
Hypotension
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Gastrointestinal disorders
Nausea
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Renal and urinary disorders
Nephrolithiasis
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
2/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Cardiac disorders
Sinus tachycardia
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Gastrointestinal disorders
Stomatitis
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Gastrointestinal disorders
Vomiting
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Investigations
Weight decreased
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Psychiatric disorders
Anxiety
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Gastrointestinal disorders
Diarrhoea
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
2/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Psychiatric disorders
Insomnia
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Investigations
Lymphocyte count decreased
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
General disorders
Mucosal inflammation
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Infections and infestations
Paronychia
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Skin and subcutaneous tissue disorders
Skin atrophy
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Nervous system disorders
Headache
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Eye disorders
Vision blurred
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Investigations
Neutrophil count increased
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Renal and urinary disorders
Acute kidney injury
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Investigations
Aspartate aminotransferase increased
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Investigations
Blood creatinine increased
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Psychiatric disorders
Confusional state
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Investigations
White blood cell count increased
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Metabolism and nutrition disorders
Hyperglycaemia
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Nervous system disorders
Syncope
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Reproductive system and breast disorders
Breast pain
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
General disorders
Chills
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Eye disorders
Eye irritation
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Infections and infestations
Nasopharyngitis
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
General disorders
Oedema peripheral
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Injury, poisoning and procedural complications
Skin abrasion
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Nervous system disorders
Lethargy
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Investigations
Lipase Increased
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Investigations
Amylase Increased
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Blood and lymphatic system disorders
International normalised ratio increased
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Renal and urinary disorders
Proteinuria
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Injury, poisoning and procedural complications
Contusion
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Nervous system disorders
Ataxia
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Nervous system disorders
Peroneal nerve palsy
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Injury, poisoning and procedural complications
Skin laceration
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
100.0%
1/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
Gastrointestinal disorders
Pancreatitis
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
50.0%
1/2 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
0.00%
0/1 • Up to 18 months
The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.

Additional Information

Howard Franklin, MD

Assertio Holdings

Phone: 224 419 7106

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER