Trial Outcomes & Findings for Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer (NCT NCT02659514)

NCT ID: NCT02659514

Last Updated: 2022-03-11

Results Overview

ORR was defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) among participants in the Evaluable Population assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR was based on investigator assessed BOR. Per RECIST v1.1 for target lesions, CR was disappearance of all target tumor lesions (TLs) and all target lymph nodes (LNs) with short axis \<10mm. PR was ≥30% decrease in sum of diameters (SOD) from Baseline, and not progressive disease (PD) (≥20% increase in SOD from previous smallest SOD on study, and an absolute increase of ≥5mm).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 67 participants
• Primary outcome timeframe: Up to 24 months
• Results posted on: 2022-03-11

Participant Flow

A total of 67 participants were enrolled at 19 sites in the United States in the study which was conducted from 22 February 2016 to 11 March 2020.

Participant milestones

Measure	Cohort 1: Poziotinib 24 mg Participants received poziotinib 24 milligrams (mg), administered as three 8 mg tablets, orally, once daily (QD) on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable adverse events (AEs) or for up to a maximum of 24 months, whichever occurs first.	Cohort 2: Poziotinib 16 mg Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
Overall Study STARTED	33	34
Overall Study Safety Population	33	34
Overall Study Evaluable Population	30	27
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	32	34

Reasons for withdrawal

Measure	Cohort 1: Poziotinib 24 mg Participants received poziotinib 24 milligrams (mg), administered as three 8 mg tablets, orally, once daily (QD) on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable adverse events (AEs) or for up to a maximum of 24 months, whichever occurs first.	Cohort 2: Poziotinib 16 mg Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
Overall Study Adverse Event	3	12
Overall Study Disease Progression	23	13
Overall Study Withdrawal by Subject	0	4
Overall Study Lost to Follow-up	0	1
Overall Study Death	6	1
Overall Study Reason Unspecified	0	3

Baseline Characteristics

Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer

Baseline characteristics by cohort

Measure	Cohort 1: Poziotinib 24 mg n=33 Participants Participants received poziotinib 24 mg, administered as three 8 mg tablets, orally, QD on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.	Cohort 2: Poziotinib 16 mg n=34 Participants Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.	Total n=67 Participants Total of all reporting groups
Age, Continuous	56.4 years STANDARD_DEVIATION 13.82 • n=5 Participants	58.1 years STANDARD_DEVIATION 11.10 • n=7 Participants	57.3 years STANDARD_DEVIATION 12.45 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	34 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized White	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Population: Evaluable Population included all enrolled participants who completed at least 1 cycle of poziotinib treatment and had at least 1 post-baseline tumor response evaluation using RECIST, v 1.1.

ORR was defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) among participants in the Evaluable Population assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR was based on investigator assessed BOR. Per RECIST v1.1 for target lesions, CR was disappearance of all target tumor lesions (TLs) and all target lymph nodes (LNs) with short axis <10mm. PR was ≥30% decrease in sum of diameters (SOD) from Baseline, and not progressive disease (PD) (≥20% increase in SOD from previous smallest SOD on study, and an absolute increase of ≥5mm).

Outcome measures

Measure	Cohort 1: Poziotinib 24 mg n=30 Participants Participants received poziotinib 24 mg, administered as three 8 mg tablets, orally, QD on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.	Cohort 2: Poziotinib 16 mg n=27 Participants Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
Objective Response Rate (ORR)	30 percentage of participants Interval 14.7 to 49.4	30 percentage of participants Interval 13.8 to 50.2

SECONDARY outcome

Timeframe: Up to 24 Months

Population: Evaluable Population included all enrolled participants who completed at least 1 cycle of poziotinib treatment and had at least 1 post-baseline tumor response evaluation using RECIST, v 1.1.

PFS was the duration of time (in months) from first administration of study treatment to date of first documented disease progression or death from any cause. PFS of living participants without documented PD was censored at the time of last tumor assessment or the date of first treatment if there was no post-baseline tumor assessment. Per RECIST v1.1 for target lesions, PD was defined as ≥20% increase in SOD from previous smallest SOD on study, and an absolute increase of ≥5mm.

Outcome measures

Measure	Cohort 1: Poziotinib 24 mg n=30 Participants Participants received poziotinib 24 mg, administered as three 8 mg tablets, orally, QD on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.	Cohort 2: Poziotinib 16 mg n=27 Participants Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
Progression Free Survival (PFS)	4.1 months Interval 1.5 to 5.6	4.9 months Interval 1.8 to 7.4

SECONDARY outcome

Timeframe: Up to 24 months

Population: Evaluable Population included all enrolled participants who completed at least 1 cycle of poziotinib treatment and had at least 1 post-baseline tumor response evaluation using RECIST, v 1.1.

DCR was the percentage of participants whose best response was CR, PR or stable disease (SD) among participants in the Evaluable Population assessed per RECIST v1.1. DCR was based on investigator-assessed BOR. Per RECIST v1.1 for target lesions, CR was defined as disappearance of all target TLs and all target LNs with short axis <10mm. PR was ≥30% decrease in sum of diameters (SOD) from Baseline, and not progressive disease (≥20% increase in SOD from previous smallest SOD on study, and an absolute increase of ≥5mm). SD was SOD change neither sufficient for PR nor sufficient for PD.

Outcome measures

Measure	Cohort 1: Poziotinib 24 mg n=30 Participants Participants received poziotinib 24 mg, administered as three 8 mg tablets, orally, QD on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.	Cohort 2: Poziotinib 16 mg n=27 Participants Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
Disease Control Rate (DCR)	60 percentage of participants Interval 40.6 to 77.3	78 percentage of participants Interval 57.7 to 91.4

SECONDARY outcome

Timeframe: Up to 24 months

Population: Evaluable Population included all enrolled participants who completed at least 1 cycle of poziotinib treatment and had at least 1 post-baseline tumor response evaluation using RECIST, v 1.1.

TTP was defined as the time (in months) from first administration of study drug to tumor progression, which excluded death without tumor progression, by the end of study. TTP of participants who died without documented PD was censored at date of death. TTP of living participants without documented PD was censored at the same time as PFS, which was the last tumor assessment or the date of first treatment if there was no post-baseline tumor assessment. Per RECIST v1.1 for target lesions, PD was defined as ≥20% increase in SOD from previous smallest SOD on study, and an absolute increase of ≥5mm.

Outcome measures

Measure	Cohort 1: Poziotinib 24 mg n=30 Participants Participants received poziotinib 24 mg, administered as three 8 mg tablets, orally, QD on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.	Cohort 2: Poziotinib 16 mg n=27 Participants Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
Time to Progression (TTP)	4.1 months Interval 1.5 to 5.6	4.9 months Interval 1.8 to 7.4

SECONDARY outcome

Timeframe: Up to 24 months

Population: Evaluable Population included all participants who had received at least one cycle of poziotinib and had at least one evaluable post-baseline tumor response evaluation using response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST, v1.1). Overall number of participants analyzed is the number of participants with best overall response of CR or PR.

DoR was evaluated only for participants whose BOR was CR or PR and was defined as the time (in months) from the date that response evaluation criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that PD or death was documented. DoR of participants without documented PD or death was censored at the time of last tumor assessment. Per RECIST v1.1 for target lesions, CR was defined as disappearance of all target tumor lesions (TLs) and all target lymph nodes (LNs) with short axis <10mm. PR was defined as ≥30% decrease in sum of diameters (SOD) from Baseline, and not PD. PD was defined as ≥20% increase in SOD from previous smallest SOD on study, and an absolute increase of ≥5mm).

Outcome measures

Measure	Cohort 1: Poziotinib 24 mg n=9 Participants Participants received poziotinib 24 mg, administered as three 8 mg tablets, orally, QD on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.	Cohort 2: Poziotinib 16 mg n=8 Participants Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
Duration of Response (DoR)	5.7 months Interval 1.8 to The upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of participants with event.	13.0 months Interval 2.2 to The upper limit of 95% CI was not estimable due to insufficient number of participants with event.

SECONDARY outcome

Timeframe: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (Up to approximately 25 months)

Population: Safety Population included all participants who received at least 1 dose of poziotinib.

An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were AEs that occurred or worsened from the first dose of study treatment until 35 (± 5) days after the last dose of study treatment.

Outcome measures

Measure	Cohort 1: Poziotinib 24 mg n=33 Participants Participants received poziotinib 24 mg, administered as three 8 mg tablets, orally, QD on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.	Cohort 2: Poziotinib 16 mg n=34 Participants Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)	33 participants	33 participants

SECONDARY outcome

Timeframe: For Cohort 1: Pre-dose and 1 and 2 hours post-dose on Day 1 of Cycles 1, 2, and 3, and pre-dose on Day 14 of Cycle 1 For Cohort 2: Day 1 of Cycle 1 pre-dose and 30 minutes, 1,1.5,2,3, 4, 6, and 24 hours post-dose of Day 1 of Cycle 1

Population: Pharmacokinetic analyses specified in the protocol were not performed as the samples were no longer stable at the time of the analysis.

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1: Poziotinib 24 mg

Serious events: 14 serious events

Other events: 33 other events

Deaths: 6 deaths

Cohort 2: Poziotinib 16 mg

Serious events: 16 serious events

Other events: 33 other events

Deaths: 1 deaths

Serious adverse events

Measure	Cohort 1: Poziotinib 24 mg n=33 participants at risk Participants received poziotinib 24 mg, administered as three 8 mg tablets, orally, QD on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.	Cohort 2: Poziotinib 16 mg n=34 participants at risk Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
Blood and lymphatic system disorders Anaemia	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Cardiac disorders Cardio-respiratory arrest	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Cardiac disorders Atrial fibrillation	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Ear and labyrinth disorders Vertigo	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Diarrhoea	18.2% 6/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Vomiting	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Nausea	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
General disorders Asthenia	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Pneumonia	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Soft tissue infection	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Bacteraemia	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Cellulitis	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Enterocolitis infectious	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Rash pustular	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Urinary tract infection	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Injury, poisoning and procedural complications Femur fracture	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Metabolism and nutrition disorders Dehydration	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Nervous system disorders Haemorrhage intracranial	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Nervous system disorders Spinal cord compression	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Nervous system disorders Syncope	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Nervous system disorders Seizure like phenomena	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Renal and urinary disorders Acute kidney injury	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Renal and urinary disorders Nephrolithiasis	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Rash	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.

Other adverse events

Measure	Cohort 1: Poziotinib 24 mg n=33 participants at risk Participants received poziotinib 24 mg, administered as three 8 mg tablets, orally, QD on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.	Cohort 2: Poziotinib 16 mg n=34 participants at risk Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
Metabolism and nutrition disorders Hypokalaemia	21.2% 7/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	35.3% 12/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Metabolism and nutrition disorders Dehydration	15.2% 5/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	11.8% 4/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Blood and lymphatic system disorders Anaemia	15.2% 5/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	14.7% 5/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Blood and lymphatic system disorders Thrombocytopenia	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	8.8% 3/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Blood and lymphatic system disorders Lymphopenia	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Cardiac disorders Pericardial effusion	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Cardiac disorders Tachycardia	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Cardiac disorders Ventricular tachycardia	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Ear and labyrinth disorders Ear pain	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Ear and labyrinth disorders Ear discomfort	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Ear and labyrinth disorders Otorrhoea	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Endocrine disorders Hypothyroidism	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Eye disorders Dry eye	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Eye disorders Eye discharge	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Eye disorders Cataract	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Eye disorders Eye irritation	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Eye disorders Eye swelling	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Eye disorders Ocular hyperaemia	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Eye disorders Vitreous floaters	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Eye disorders Periorbital oedema	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Eye disorders Conjunctival haemorrhage	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Eye disorders Diplopia	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Eye disorders Lacrimation increased	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Diarrhoea	90.9% 30/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	85.3% 29/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Stomatitis	48.5% 16/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	50.0% 17/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Vomiting	48.5% 16/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	32.4% 11/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Nausea	36.4% 12/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	50.0% 17/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Constipation	15.2% 5/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	23.5% 8/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Dry mouth	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	11.8% 4/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Abdominal pain upper	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Abdominal distension	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Cheilitis	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Flatulence	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Gastrooesophageal reflux disease	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Oral discomfort	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Oral pain	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Proctalgia	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Dysphagia	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Gastritis	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Gingival pain	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Glossodynia	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Lip oedema	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Mouth ulceration	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Abdominal pain	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	11.8% 4/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Dyspepsia	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	8.8% 3/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Anal incontinence	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Anal inflammation	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Proctitis	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
General disorders Fatigue	54.5% 18/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	50.0% 17/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
General disorders Mucosal inflammation	24.2% 8/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	14.7% 5/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
General disorders Pyrexia	12.1% 4/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	14.7% 5/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
General disorders Oedema peripheral	12.1% 4/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	8.8% 3/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
General disorders Pain	12.1% 4/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
General disorders Asthenia	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
General disorders Chills	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
General disorders Influenza like illness	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	8.8% 3/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
General disorders Oedema	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
General disorders Gait disturbance	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
General disorders Multiple organ dysfunction syndrome	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
General disorders Face oedema	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
General disorders Infusion site rash	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
General disorders Localised oedema	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
General disorders Tenderness	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Urinary tract infection	21.2% 7/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Paronychia	12.1% 4/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	8.8% 3/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Conjunctivitis	9.1% 3/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Fungal infection	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Cellulitis	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Vulvovaginal mycotic infection	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Herpes zoster	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Rash pustular	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Candida infection	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Tinea pedis	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Upper respiratory tract infection	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Angular cheilitis	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Cystitis	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Ear infection	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Localised infection	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Ophthalmic herpes zoster	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Oral candidiasis	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Sinusitis	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Skin candida	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Soft tissue infection	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Fungal skin infection	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Clostridium difficile infection	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Enterocolitis infection	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Groin infection	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Nail infection	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Rhinitis	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Skin infection	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Tongue fungal infection	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Infections and infestations Wound infection	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Injury, poisoning and procedural complications Fall	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Injury, poisoning and procedural complications Nail injury	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Injury, poisoning and procedural complications Procedural pain	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Injury, poisoning and procedural complications Scapula fracture	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Injury, poisoning and procedural complications Compression fracture	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Injury, poisoning and procedural complications Contusion	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Injury, poisoning and procedural complications Skeletal injury	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Weight decreased	18.2% 6/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	14.7% 5/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Blood creatinine increased	12.1% 4/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	11.8% 4/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Aspartate aminotransferase increased	12.1% 4/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Blood alkaline phosphatase increased	9.1% 3/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Blood potassium decreased	9.1% 3/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Alanine aminotransferase increased	9.1% 3/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Blood uric acid increased	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Blood magnesium decreased	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Lymphocyte count decreased	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations White blood cell count increased	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Neutrophil count increased	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Platelet count decreased	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Blood bilirubin increased	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Blood calcium decreased	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Blood urea increased	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Glomerular filtration rate decreased	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Glomerular filtration rate increased	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Haematocrit decreased	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Haemoglobin decreased	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Liver function test abnormal	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Neutrophil count decreased	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Blood chloride decreased	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Blood phosphorus decreased	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Ejection fraction decreased	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Gamma-glutamyltransferase increased	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Investigations Monocyte count increased	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Metabolism and nutrition disorders Decreased Appetite	39.4% 13/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	47.1% 16/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Metabolism and nutrition disorders Hypomagnesaemia	9.1% 3/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	26.5% 9/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Metabolism and nutrition disorders Hyponatraemia	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Metabolism and nutrition disorders Hypophosphataemia	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	8.8% 3/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Metabolism and nutrition disorders Hypercalcaemia	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Metabolism and nutrition disorders Acidosis	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Metabolism and nutrition disorders Hyperphosphataemia	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	12.1% 4/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	8.8% 3/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Musculoskeletal and connective tissue disorders Arthralgia	12.1% 4/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Musculoskeletal and connective tissue disorders Muscular weakness	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Musculoskeletal and connective tissue disorders Myalgia	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Musculoskeletal and connective tissue disorders Back pain	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Musculoskeletal and connective tissue disorders Bone pain	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Musculoskeletal and connective tissue disorders Pain in extremity	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Nervous system disorders Dizziness	18.2% 6/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	17.6% 6/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Nervous system disorders Headache	15.2% 5/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	11.8% 4/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Nervous system disorders Dysgeusia	9.1% 3/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	11.8% 4/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Nervous system disorders Burning sensation	9.1% 3/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Nervous system disorders Somnolence	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Nervous system disorders Syncope	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Nervous system disorders Balance disorder	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Nervous system disorders Neuropathy peripheral	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Nervous system disorders Neuralgia	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Nervous system disorders Dysarthria	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Nervous system disorders Dyskinesia	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Nervous system disorders Memory impairment	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Nervous system disorders Sensory disturbance	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Psychiatric disorders Anxiety	12.1% 4/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Psychiatric disorders Agitation	9.1% 3/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Psychiatric disorders Depression	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Psychiatric disorders Insomnia	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Psychiatric disorders Delirium	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Psychiatric disorders Irritability	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Psychiatric disorders Confusional state	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Renal and urinary disorders Dysuria	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Renal and urinary disorders Urinary incontinence	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Renal and urinary disorders Acute kidney injury	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Renal and urinary disorders Haematuria	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Renal and urinary disorders Hydronephrosis	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Renal and urinary disorders Nephrolithiasis	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Reproductive system and breast disorders Vulvovaginal discomfort	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Reproductive system and breast disorders Breast pain	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Reproductive system and breast disorders Vulvovaginal inflammation	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Reproductive system and breast disorders Perineal pain	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Reproductive system and breast disorders Vulvovaginal burning sensation	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Epistaxis	15.2% 5/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	17.6% 6/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Cough	12.1% 4/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	11.8% 4/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.1% 4/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.1% 4/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Pleural effusion	9.1% 3/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	8.8% 3/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Nasal dryness	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Sinus congestion	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Dysphonia	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Hiccups	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Throat irritation	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Rash	60.6% 20/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	44.1% 15/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Dry skin	33.3% 11/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	17.6% 6/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Dermatitis acneiform	24.2% 8/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	29.4% 10/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Alopecia	18.2% 6/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	20.6% 7/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Rash maculo-papular	9.1% 3/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	23.5% 8/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Pruritus	9.1% 3/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	14.7% 5/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	11.8% 4/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Erythema	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	8.8% 3/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Pruritus generalised	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Rash macular	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Skin lesion	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Skin irritation	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Dermatitis bullous	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Rash erythematous	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Rash generalised	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Skin disorder	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Urticaria	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Acne	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Hirsutism	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Koilonychia	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Onychomadesis	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	2.9% 1/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Surgical and medical procedures Skin lesion excision	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	0.00% 0/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Vascular disorders Hypertension	6.1% 2/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Vascular disorders Hypotension	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	8.8% 3/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.
Vascular disorders Lymphoedema	3.0% 1/33 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.	5.9% 2/34 • All-Cause Mortality: From the first dose of study drug administration up to approximately 48.5 months; Serious and Other Adverse Events: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (up to approximately 25 months) Safety population included all participants who received at least 1 dose of poziotinib.

Additional Information

Shanta Chawla

Spectrum Pharmaceuticals, Inc, Research and Development Office 157 Technology Drive Irvine, CA 92618

Phone: 9497886700

Email: shanta.chawla@sppirx.com

Results disclosure agreements

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