Trial Outcomes & Findings for Dose Escalation of Lapatinib With Paclitaxel in Ovarian Cancer (NCT NCT04608409)
NCT ID: NCT04608409
Last Updated: 2025-06-29
Results Overview
Number of patients with progression-free survival at one year.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
One year
Results posted on
2025-06-29
Participant Flow
Sixteen patients were evaluable for efficacy, toxicity, and response.
Participant milestones
| Measure |
Lapatinib - Group 1
Patients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 2
Patients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 3
Patients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
7
|
|
Overall Study
COMPLETED
|
2
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Lapatinib - Group 1
Patients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 2
Patients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 3
Patients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
2
|
Baseline Characteristics
Dose Escalation of Lapatinib With Paclitaxel in Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Lapatinib - Group 1
n=3 Participants
Patients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 2
n=6 Participants
Patients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 3
n=7 Participants
Patients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
75 years
n=5 Participants
|
64 years
n=7 Participants
|
66 years
n=5 Participants
|
67.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
16 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: One yearNumber of patients with progression-free survival at one year.
Outcome measures
| Measure |
Lapatinib - Group 3
n=7 Participants
Patients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 1
n=3 Participants
Patients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 2
n=6 Participants
Patients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
|---|---|---|---|
|
Progression-free Survival.
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 weeksDose limiting toxicity (DLT) is calculated as the total number of patients experiencing DLTs divided by the total number treated.
Outcome measures
| Measure |
Lapatinib - Group 3
n=7 Participants
Patients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 1
n=3 Participants
Patients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 2
n=6 Participants
Patients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicity
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 15 days (on day 8 and 15)Population: Plasma lapatinib concentrations were analyzed among samples from patients who completed dosing for the assigned treatment arm and had blood drawn within 24 hours of the last lapatinib dose.
Plasma concentrations of lapatinib will be measured on days 8 and 15 prior to paclitaxel administration
Outcome measures
| Measure |
Lapatinib - Group 3
n=4 Participants
Patients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 1
n=3 Participants
Patients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 2
n=4 Participants
Patients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
|---|---|---|---|
|
Change in Plasma Concentration of Lapatinib Cycle 1
Day 8
|
2490 ng/ml
Standard Deviation 1720
|
2579 ng/ml
Standard Deviation 1620
|
1593 ng/ml
Standard Deviation 2100
|
|
Change in Plasma Concentration of Lapatinib Cycle 1
Day 15
|
2851 ng/ml
Standard Deviation 2160
|
1630 ng/ml
Standard Deviation 590
|
2370 ng/ml
Standard Deviation 1910
|
SECONDARY outcome
Timeframe: 15 days (on day 8 and 15)Population: Plasma lapatinib concentrations were analyzed among samples from patients who completed dosing for the assigned treatment arm and had blood drawn within 24 hours of the last lapatinib dose.
Plasma concentrations of lapatinib will be measured on days 8 and 15 prior to paclitaxel administration
Outcome measures
| Measure |
Lapatinib - Group 3
n=4 Participants
Patients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 1
n=2 Participants
Patients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 2
n=3 Participants
Patients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
|---|---|---|---|
|
Change in Plasma Concentration of Lapatinib Cycle 2
Day 15
|
2312 ng/ml
Standard Deviation 1490
|
2002 ng/ml
Standard Deviation 1120
|
3393 ng/ml
Standard Deviation 3940
|
|
Change in Plasma Concentration of Lapatinib Cycle 2
Day 8
|
2951 ng/ml
Standard Deviation 2650
|
2002 ng/ml
Standard Deviation 750
|
2987 ng/ml
Standard Deviation 2900
|
SECONDARY outcome
Timeframe: 15 days (on day 8 and 15)Population: Plasma lapatinib concentrations were analyzed among samples from patients who completed dosing for the assigned treatment arm and had blood drawn within 24 hours of the last lapatinib dose.
Plasma concentrations of lapatinib will be measured on days 8 and 15 prior to paclitaxel administration
Outcome measures
| Measure |
Lapatinib - Group 3
n=4 Participants
Patients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 1
n=2 Participants
Patients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 2
n=3 Participants
Patients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
|---|---|---|---|
|
Change in Plasma Concentration of Lapatinib Cycle 3
Day 8
|
2175 ng/ml
Standard Deviation 1790
|
1439 ng/ml
|
1499 ng/ml
Standard Deviation 790
|
|
Change in Plasma Concentration of Lapatinib Cycle 3
Day 15
|
1824 ng/ml
Standard Deviation 1130
|
2242 ng/ml
Standard Deviation 1460
|
1031 ng/ml
Standard Deviation 600
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 days (on day 1, 8 and 15)Levels of ABCB1 expression (cell-free RNA) will be measured using Nanostring sequencing.
Outcome measures
Outcome data not reported
Adverse Events
Lapatinib - Group 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Lapatinib - Group 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 6 deaths
Lapatinib - Group 3
Serious events: 0 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Lapatinib - Group 1
n=3 participants at risk
Patients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 2
n=6 participants at risk
Patients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 3
n=7 participants at risk
Patients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • Number of events 2 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Cardiac disorders
Ventricular tachycardia
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
Other adverse events
| Measure |
Lapatinib - Group 1
n=3 participants at risk
Patients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 2
n=6 participants at risk
Patients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
Lapatinib - Group 3
n=7 participants at risk
Patients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib and Paclitaxel: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
|
|---|---|---|---|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • Number of events 4 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
33.3%
2/6 • Number of events 3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
71.4%
5/7 • Number of events 7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Investigations
White blood cell decreased
|
66.7%
2/3 • Number of events 3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
33.3%
2/6 • Number of events 4 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
71.4%
5/7 • Number of events 7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Number of events 4 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
50.0%
3/6 • Number of events 6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
28.6%
2/7 • Number of events 2 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
33.3%
2/6 • Number of events 3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
28.6%
2/7 • Number of events 2 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
28.6%
2/7 • Number of events 3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
33.3%
2/6 • Number of events 3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
14.3%
1/7 • Number of events 3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
28.6%
2/7 • Number of events 2 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 5 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
14.3%
1/7 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
14.3%
1/7 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Investigations
Other
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
14.3%
1/7 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • Number of events 5 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
66.7%
4/6 • Number of events 8 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
57.1%
4/7 • Number of events 9 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
33.3%
2/6 • Number of events 3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
71.4%
5/7 • Number of events 13 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Number of events 3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
33.3%
2/6 • Number of events 3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
71.4%
5/7 • Number of events 10 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
66.7%
2/3 • Number of events 8 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
50.0%
3/6 • Number of events 3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
28.6%
2/7 • Number of events 5 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
42.9%
3/7 • Number of events 3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 2 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
28.6%
2/7 • Number of events 4 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
42.9%
3/7 • Number of events 5 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
42.9%
3/7 • Number of events 8 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
42.9%
3/7 • Number of events 3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Number of events 3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
28.6%
2/7 • Number of events 4 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 2 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
14.3%
1/7 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
3/3 • Number of events 6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
83.3%
5/6 • Number of events 16 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
85.7%
6/7 • Number of events 22 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
33.3%
2/6 • Number of events 2 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
28.6%
2/7 • Number of events 3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
33.3%
2/6 • Number of events 2 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
14.3%
1/7 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
83.3%
5/6 • Number of events 9 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
42.9%
3/7 • Number of events 9 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
General disorders
Fatigue
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
33.3%
2/6 • Number of events 2 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
14.3%
1/7 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
General disorders
Edema limbs
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
14.3%
1/7 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
General disorders
Malaise
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
42.9%
3/7 • Number of events 5 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
33.3%
2/6 • Number of events 3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
14.3%
1/7 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • Number of events 2 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
14.3%
1/7 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
33.3%
2/6 • Number of events 2 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
14.3%
1/7 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
33.3%
2/6 • Number of events 2 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
14.3%
1/7 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
33.3%
2/6 • Number of events 2 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
14.3%
1/7 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
14.3%
1/7 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Skin and subcutaneous tissue disorders
Other
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
14.3%
1/7 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Cardiac disorders
Ventricular tachycardia
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
33.3%
2/6 • Number of events 2 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
14.3%
1/7 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Renal and urinary disorders
Other
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Reproductive system and breast disorders
Other
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
14.3%
1/7 • Number of events 4 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
14.3%
1/7 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other
|
33.3%
1/3 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/6 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
16.7%
1/6 • Number of events 1 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
0.00%
0/7 • 30 days after discontinuation (last dose) of lapatinib, up to 3 cycles (a cycle is 28 days)
If a participant experienced more than one adverse event within a toxicity category, the participant is counted once under that category. If a participant had more than one count for a particular toxicity, the participant was counted once for that toxicity. CTCAE v5.0 was used for coding.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place