Neoplasms, Gastrointestinal Tract
Conditions
Keywords
tumor biopsy, capecitabine, first line, Gastro Esophageal (GE) Junction Cancer, Gastric cancer, newly diagnosed, GE junction, lapatinib, metastatic or unresectable
Brief summary
The study will determine if changes in expression of markers involved in the 5-FU pathways are associated with response to treatment with the combination of lapatinib and capecitabine independent of tumor erbB2 status.
Interventions
oral lapatinib (1250mg) administered as a monotherapy run-in followed by its combination with capecitabine
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has signed inform consent * Untreated, newly diagnosed, advanced metastatic or unresectable gastric cancer, including the gastro-esophageal junction * Tumor accessible to and patient consent for endoscopic biopsy at study start and after 7 days of single agent Lapatinib * Measurable disease according to RECIST criteria * Male or female \> or = 18 years of age * Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram * must have adequate organ function as defined by baseline laboratory values
Exclusion criteria
* Gastric carcinoid, sarcomas, or squamous cell cancer * Pregnant or lactating females * Intractable nausea, vomiting, or gastro intestinal obstruction requiring decompression and drainage with a gastric tube or nasogastric suction. * patients who require continuous enteral feeding * Malabsorption syndrome or uncontrolled inflammatory GI disease (Crohn's or ulcerative colitis * Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Start of Run-in Period in Biomarker Expression Levels at Day 0 | evaluated at baseline and after 7 days of study treatment | Participants were analyzed for intratumoral expression levels of genes involved in the 5-fluorouracil (FU) pathway and lapatinib-targeted genes. Change in biomarker expression levels was calculated as the levels measured after the lapatinib Run-in Period (Baseline) of the study minus the levels measured at the start of monotherapy (Day -7). EGFR, epidermal growth factor receptor; HER, human epidermal growth factor receptor. Data are presented as ratios of the normalized gene expression of the target gene to that of beta actin. |
| Response Rate (Measured as the Percentage of Participants With Response [Complete Response or Partial Response]) | From Baseline (Day 0) until disease progression or death due to any cause evaluated every 6 or 12 weeks (up to approximately 85 weeks) | Response is defined as documented evidence of complete response (CR) or partial response (PR). The investigator evaluated response based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). Partial response for TLs is defined as \>= a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs it is defined as the persistence of 1 or more non-TL and no new TLs or non-TLs. |
| Percentage of Participants (Par.) With 5-month Progression-free Survival (PFS) | From initial treatment up to 24 weeks (next available assessment after the 5-month assessment for progressive disease) | 5-month (mo.) PFS was defined as the percentage of par. who were alive/progression free for 5 months from the time of initial treatment. PFS is defined as the time from the initial treatment until the first observation of disease progression (DP)/death due to any cause; the percentage of par. whose follow-up ended or was ongoing was reported. DP is defined as symptomatic progression or the appearance of \>=1 NL and/or unequivocal progression of existing non-TLs, and a \>=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression (All Deaths Due to Non-PD Are Treated as Competing Risk) | From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks) | Time to progression is defined as the time from the initial treatment (first dose) until the first documented radiological symptomatic sign of disease progression. Time to progression data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of occurrence of a particular event is reached to a particular point. All factors that hinder the observation of the event are defined as competing risks. |
| Time to Response | Baseline (Day 0) until first documented evidence of response (up to approximately 60 weeks) | Time to response is defined as the time from the initial treatment until the first documented evidence of CR (disappearance of all TLs and non-TLs and the appearance of no new lesions) or PR (\>= a 30% decrease in the sum of the longest diameter of TLs, taking as reference the Baseline sum longest diameter) (whichever status was recorded first). Time to response data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of the occurrence of a particular event is reached to a particular point. |
| Duration of Response | From date of first documented evidence of response until the date of first documented sign of disease progression or death due to any cause (up to approximately 78 weeks) | Duration of response is defined as the time from the first documented evidence of tumor response (CR or PR) until the first documented sign of disease progression or death due to any cause, whichever came first. |
| Number of Participants in the Indicated Categories for Best Overall Response (BOR) | From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks) | Best overall response was evaluated by the investigator based on RECIST criteria: CR; PR; Stable Disease (SD), defined as no sufficient shrinkage to qualify for PR, no sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD, defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of \>= 1 new lesions; Unknown, defined as participants who do not have CR, PR, SD, or PD. |
| Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy | Toxicity was measured in grades (AE severity) per National Cancer Institute Common Toxicity Criteria for Adverse Event (NCI CTCAE) version (v) 3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For albumin (per blood samples): G 1 (\<lower limit of normal \[LLN\] to 3 grams per deciliter \[g/dL\]), mild; G 2 (\<3 to 2 g/dL), moderate; G 3 (\<2 g/dL), severe; G 4 (value not available), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. |
| Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy | Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For ALP: G 1 (upper limit of normal \[ULN\] to 2.5x ULN), mild; G 2 (\>2.5 to 5.0x ULN), moderate; G 3 (\>5.0 to 20.0x ULN), severe; G 4 (\>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. |
| Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy | Blood samples were collected for the evaluation of AST. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For AST: G 1 (\>ULN to 2.5x ULN), mild; G 2 (\>2.5 to 5.0x ULN), moderate; G 3 (\>5.0 to 20.0x ULN), severe; G 4 (\>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. |
| Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy | Blood samples were collected for the evaluation of ALT. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For ALT: G 1 (\>ULN to 2.5x ULN), mild; G 2 (\>2.5 to 5.0x ULN), moderate; G 3 (\>5.0 to 20.0x ULN), severe; G 4 (\>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. |
| Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy | Blood samples were collected for the evaluation of total bilirubin. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For total bilirubin: G 1 (\>ULN to 1.5x ULN), mild; G 2 (\>1.5 to 3.0x ULN), moderate; G 3 (\>3.0 to 10.0x ULN), severe; G 4 (\>10.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. |
| Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy | Blood samples were collected for calcium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For calcium (low and high, respectively): G 1 (\<LLN to 8.0 mg/dL; \>ULN to 11.5x ULN), mild; G 2 (\<8.0 to 7.0 mg/dL; \>11.5 to 12.5 ULN), moderate; G 3 (\<7.0 to 6.0 mg/dL; \>12.5 to 13.5 mg/dL), severe; G 4 (\<6 mg/dL; \>13.5 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. |
| PFS | From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks) | PFS is defined as the time from the initial treatment until the first observation of disease progression or death due to any cause. The date of documented disease progression was defined as the earliest date of radiographic disease assessment progression or symptomatic progression, whichever came first. For participants who did not die/progress, survival was censored at the time of the last assessment (or contact). |
| Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy | Blood samples were collected for the evaluation of glucose. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For glucose (high and low, respectively): G 1 (\>ULN to 160 mg/dL; \<LLN to 55 mg/dL), mild; G 2 (\>160 to 250 mg/dL; \<55 to 40 mg/dL), moderate; G 3 (\>250 to 500 mg/dL; \<40 to 30 mg/dL), severe; G 4 (\>500 mg/dL; \<30 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. |
| Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy | Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For potassium (high and low \[per blood samples\], respectively): G 1 (\>ULN to 5.5 millimoles per liter \[mmol/L\]; \<LLN to 3.0 mmol/L), mild; G 2 (\>5.5 to 6.0 mmol/L; value not available), moderate; G 3 (\>6.0 to 7.0 mmol/L; \<3.0 to 2.5 mmol/L), severe; G 4 (\>7.0 mmol/L; \<2.5 mmol/L), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. |
| Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy | Blood samples were collected for magnesium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For magnesium (high and low, respectively): G 1 (\>ULN to 3.0 mg/dL; \<LLN to 1.2 mg/dL), mild; G 2 (value not available; \<1.2 to 0.9 mg/dL), moderate; G 3 (\>3.0 to 8.0 mg/dL; \<0.9 to 0.7 mg/dL), severe; G 4 (\>8.0 mg/dL; \<0.7 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. |
| Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy | Blood samples were collected for sodium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of each AE severity. For sodium (high and low, respectively): G 1 (\>ULN to 150 mmol/L; \<LLN to 130 mmol/L), mild; G 2 (\>150 to 155 mmol/L; value not available), moderate; G 3 (\>155 to 160 mmol/L; \<130 to 120 mmol/L), severe; G 4 (\>160 mmol/L; \<120 mmol/L), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. |
| Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy | Blood samples were collected for the evaluation of hemoglobin. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For hemoglobin: G 1 (\<LLN to 10 g/dL), mild; G 2 (\<10.0 to 8.0 g/dL), moderate; G 3 (\<8.0 to 6.5 g/dL), severe; G 4 (\<6.5 g/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. |
| Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy | Blood samples were collected for the evaluation of lymphocytes. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For lymphocytes: G 1, mild; G 2, moderate; G 3, severe; G 4, life threatening/disabling; G 5, death related to AE; ranges were provided by local laboratories. Change from Baseline was measured as any grade increase (AGI), increase to G 3 (ItoG3), and increase to G 4 (ItoG4). Worst-case on-therapy reflects the most severe change at any time point measured post treatment. |
| Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy | Blood samples were collected for the evaluation of total neutrophils. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For neutrophils: G 1 (\<LLN to 1500/millimeters cubed \[mm\^3\] of blood plasma \[bp\]), mild; G 2 (\<1500 to 1000/mm\^3 of bp), moderate; G 3 (\<1000 to 500/mm\^3 of bp), severe; G 4 (\<500/mm\^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. |
| Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy | Blood samples were collected for the evaluation of platelet count. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For platelet count: G 1 (\<LLN to 75000/mm\^3 of blood plasma \[bp\]), mild; G 2 (\<75000 to 50000/mm\^3 of bp), moderate; G 3 (\<50000 to 25000/mm\^3 of bp), severe; G 4 (\<25000/mm\^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. |
| Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy | Blood samples were collected for the evaluation of WBC count. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For WBCs: G 1 (\<LLN to 3000/mm\^3 of blood plasma \[bp\]), mild; G 2 (\<3000 to 2000/mm\^3 of bp), moderate; G 3 (\<2000 to 1000/mm\^3 of bp), severe; G 4 (\<1000/mm\^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. |
| Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy | Blood samples were collected for the evaluation of creatinine. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For creatinine: G 1 (\>ULN to 1.5x ULN), mild; G 2 (\>1.5 to 3.0x ULN), moderate; G 3 (\>3.0 to 6.0x ULN), severe; G 4 (\>6.0x ULN), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment. |
| Overall Survival (OS) | From Baseline (Day 0) until death due to any cause evaluated at approximately 12 months (up to approximately 100 weeks) | Overall survival is defined as the time from the initial treatment until death due to any cause. A death occurring during the study is defined as a death occurring during treatment or within 30 days of the last administration of study medication. |
| Time to Progression (All Deaths Are Treated as Competing Risk) | From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks) | Time to progression is defined as the time from the initial treatment (first dose) until the first documented radiological symptomatic sign of disease progression. Time to progression data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of the occurrence of a particular event is reached to a particular point. All factors that hinder the observation of the event are defined as competing risks. |
Countries
Canada, Mexico, Russia, South Korea, Taiwan, United States
Participant flow
Recruitment details
68 participants were enrolled in the study, as reflected by the enrollment number in the protocol record; however, one participant elected to not receive study treatment and was thus not included in the Intent-to-Treat Population.
Pre-assignment details
After an initial tumor biopsy (biop.), participants (par.) received lapatinib monotherapy in a 7-day Run-in Period, followed by a second biop. After the second biop., par. received a 14-day course of capecitabine in combination with lapatinib, which continued in the absence of treatment-related toxicity, until disease progression or withdrawal.
Participants by arm
| Arm | Count |
|---|---|
| Lapatinib + Capecitabine Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m\^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day. | 67 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Combined Treatment Phase | Death | 0 | 2 |
| Combined Treatment Phase | Lost to Follow-up | 0 | 2 |
| Combined Treatment Phase | Sponsor Terminated Study | 0 | 2 |
| Combined Treatment Phase | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Lapatinib + Capecitabine |
|---|---|
| Age, Continuous | 61.4 Years STANDARD_DEVIATION 12.57 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 2 participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 30 participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 1 participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 34 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 63 / 67 |
| serious Total, serious adverse events | 22 / 67 |
Outcome results
Primary
Change From Start of Run-in Period in Biomarker Expression Levels at Day 0
Participants were analyzed for intratumoral expression levels of genes involved in the 5-fluorouracil (FU) pathway and lapatinib-targeted genes. Change in biomarker expression levels was calculated as the levels measured after the lapatinib Run-in Period (Baseline) of the study minus the levels measured at the start of monotherapy (Day -7). EGFR, epidermal growth factor receptor; HER, human epidermal growth factor receptor. Data are presented as ratios of the normalized gene expression of the target gene to that of beta actin.
Time frame: evaluated at baseline and after 7 days of study treatment
Population: Intent-to-Treat (ITT) Population: all participants who entered the study and received at least one dose of lapatinib. Only those participants contributing viable samples were analyzed. Different participants contributed samples for different biomarkers.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Lapatinib | Change From Start of Run-in Period in Biomarker Expression Levels at Day 0 | Thymidylate synthase (TS), n=34 | 0.38 ratio |
| Lapatinib | Change From Start of Run-in Period in Biomarker Expression Levels at Day 0 | Deoxypyridinoline (DPD), n=26 | 0.12 ratio |
| Lapatinib | Change From Start of Run-in Period in Biomarker Expression Levels at Day 0 | EGFR/HER1, n=32 | 0.15 ratio |
| Lapatinib | Change From Start of Run-in Period in Biomarker Expression Levels at Day 0 | HER2, n=28 | 0.01 ratio |
| Lapatinib | Change From Start of Run-in Period in Biomarker Expression Levels at Day 0 | HER3, n=33 | 0.87 ratio |
p-value: 0.1Wilcoxon signed rank test
p-value: 0.097Wilcoxon signed rank test
p-value: 0.1Wilcoxon signed rank test
p-value: 0.26Wilcoxon signed rank test
p-value: 0.38Wilcoxon signed rank test
Primary
Percentage of Participants (Par.) With 5-month Progression-free Survival (PFS)
5-month (mo.) PFS was defined as the percentage of par. who were alive/progression free for 5 months from the time of initial treatment. PFS is defined as the time from the initial treatment until the first observation of disease progression (DP)/death due to any cause; the percentage of par. whose follow-up ended or was ongoing was reported. DP is defined as symptomatic progression or the appearance of \>=1 NL and/or unequivocal progression of existing non-TLs, and a \>=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started.
Time frame: From initial treatment up to 24 weeks (next available assessment after the 5-month assessment for progressive disease)
Population: ITT Population. PFS was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lapatinib | Percentage of Participants (Par.) With 5-month Progression-free Survival (PFS) | 29 percentage of participants |
95% CI: [17.9, 40.3]
Primary
Response Rate (Measured as the Percentage of Participants With Response [Complete Response or Partial Response])
Response is defined as documented evidence of complete response (CR) or partial response (PR). The investigator evaluated response based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). Partial response for TLs is defined as \>= a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs it is defined as the persistence of 1 or more non-TL and no new TLs or non-TLs.
Time frame: From Baseline (Day 0) until disease progression or death due to any cause evaluated every 6 or 12 weeks (up to approximately 85 weeks)
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lapatinib | Response Rate (Measured as the Percentage of Participants With Response [Complete Response or Partial Response]) | 17.9 percentage of participants |
95% CI: [9.6, 29.2]
Secondary
Duration of Response
Duration of response is defined as the time from the first documented evidence of tumor response (CR or PR) until the first documented sign of disease progression or death due to any cause, whichever came first.
Time frame: From date of first documented evidence of response until the date of first documented sign of disease progression or death due to any cause (up to approximately 78 weeks)
Population: ITT Population. Duration of response was estimated for only the subset of participants who had response. Duration of response was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lapatinib | Duration of Response | 18.4 weeks |
Secondary
Number of Participants in the Indicated Categories for Best Overall Response (BOR)
Best overall response was evaluated by the investigator based on RECIST criteria: CR; PR; Stable Disease (SD), defined as no sufficient shrinkage to qualify for PR, no sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD, defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of \>= 1 new lesions; Unknown, defined as participants who do not have CR, PR, SD, or PD.
Time frame: From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib | Number of Participants in the Indicated Categories for Best Overall Response (BOR) | CR | 0 participants |
| Lapatinib | Number of Participants in the Indicated Categories for Best Overall Response (BOR) | PR | 12 participants |
| Lapatinib | Number of Participants in the Indicated Categories for Best Overall Response (BOR) | SD | 31 participants |
| Lapatinib | Number of Participants in the Indicated Categories for Best Overall Response (BOR) | PD | 16 participants |
| Lapatinib | Number of Participants in the Indicated Categories for Best Overall Response (BOR) | Unknown | 8 participants |
Secondary
Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points
Blood samples were collected for the evaluation of ALT. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For ALT: G 1 (\>ULN to 2.5x ULN), mild; G 2 (\>2.5 to 5.0x ULN), moderate; G 3 (\>5.0 to 20.0x ULN), severe; G 4 (\>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Population: Safety Population. Only those participants with data available at the specified time points were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 1, AGI; n=54 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 2, AGI; n=57 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 3, AGI; n=61 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 6, AGI; n=47 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 9, AGI; n=41 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 12, AGI; n=31 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 15, AGI; n=22 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 18, AGI; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 21, AGI; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 24, AGI; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 30, AGI; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 36, AGI; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 42, AGI; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 48, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 54, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 60, AGI; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 66, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 72, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 78, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 84, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | WD/study conclusion, AGI; n=50 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Worst-case on-therapy, AGI; n=65 | 10 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 1, ItoG3; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 2, ItoG3; n=57 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 3, ItoG3; n=61 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 6, ItoG3; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 9, ItoG3; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 12, ItoG3; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 15, ItoG3; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 18, ItoG3; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 21, ItoG3; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 24, ItoG3; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 30, ItoG3; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 36, ItoG3; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 42, ItoG3; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 48, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 54, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 60, ItoG3I; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 66, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 72, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 78, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 84, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | WD/study conclusion, ItoG3; n=50 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Worst-case on-therapy, ItoG3; n=65 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 1, ItoG4; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 2, ItoG4; n=57 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 3, ItoG4; n=61 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 6, ItoG4; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 9, ItoG4; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 12, ItoG4; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 15, ItoG4; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 18, ItoG4; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 21, ItoG4; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 24, ItoG4; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 30, ItoG4; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 36, ItoG4; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 42, ItoG4; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 48, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 54, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 60, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 66, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 72, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 78, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Week 84, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | WD/study conclusion, ItoG4; n=50 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points | Worst-case on-therapy, ItoG4; n=65 | 0 participants |
Secondary
Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points
Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For ALP: G 1 (upper limit of normal \[ULN\] to 2.5x ULN), mild; G 2 (\>2.5 to 5.0x ULN), moderate; G 3 (\>5.0 to 20.0x ULN), severe; G 4 (\>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Population: Safety Population. Only those participants with data available at the specified time points were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 3, ItoG3; n=61 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 1, AGI; n=54 | 6 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 2, AGI; n=57 | 5 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 3, AGI; n=61 | 8 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 6, AGI; n=47 | 5 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 9, AGI; n=41 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 12, AGI; n=31 | 5 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 15, AGI; n=22 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 18, AGI; n=17 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 21, AGI; n=14 | 4 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 24, AGI; n=11 | 4 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 30, AGI; n=9 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 36, AGI; n=5 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 42, AGI; n=4 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 48, AGI; n=3 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 54, AGI; n=2 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 60, AGI; n=2 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 66, AGI; n=1 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 72, AGI; n=1 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 78, AGI; n=1 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 84, AGI; n=1 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | WD/study conclusion, AGI; n=49 | 8 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Worst-case on-therapy, AGI; n=65 | 21 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 1, ItoG3; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 2, ItoG3; n=57 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 6, ItoG3; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 9, ItoG3; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 12, ItoG3; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 15, ItoG3; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 18, ItoG3; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 21, ItoG3; n=14 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 24, ItoG3; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 30, ItoG3; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 36, ItoG3; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 42, ItoG3; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 48, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 54, ItoG3; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 60, ItoG3; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 66, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 72, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 78, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 84, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | WD/study conclusion, ItoG3; n=49 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Worst-case on-therapy, ItoG3; n=65 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 1, ItoG4; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 2, ItoG4; n=57 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 3, ItoG4; n=61 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 6, ItoG4; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 9, ItoG4; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 12, ItoG4; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 15, ItoG4; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 18, ItoG4; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 21, ItoG4; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 24, ItoG4; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 30, ItoG4; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 36, ItoG4; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 42, ItoG4; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 48, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 54, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 60, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 66, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 72, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 78, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Week 84, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | WD/study conclusion, ItoG4; n=49 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points | Worst-case on-therapy, ItoG4; n=65 | 0 participants |
Secondary
Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points
Blood samples were collected for the evaluation of AST. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For AST: G 1 (\>ULN to 2.5x ULN), mild; G 2 (\>2.5 to 5.0x ULN), moderate; G 3 (\>5.0 to 20.0x ULN), severe; G 4 (\>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Population: Safety Population. Only those participants with data available at the specified time points were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 1, AGI; n=54 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 2, AGI; n=57 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 3, AGI; n=61 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 6, AGI; n=47 | 6 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 9, AGI; n=41 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 12, AGI; n=31 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 15, AGI; n=22 | 4 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 18, AGI; n=17 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 21, AGI; n=14 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 24, AGI; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 30, AGI; n=9 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 36, AGI; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 42, AGI; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 48, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 54, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 60, AGI; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 66, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 72, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 78, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 84, AGI; n=1 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | WD/study conclusion, AGI; n=50 | 7 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Worst-case on-therapy, AGI; n=65 | 16 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 1, ItoG3; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 2, ItoG3; n=57 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 3, ItoG3; n=61 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 6, ItoG3; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 9, ItoG3; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 12, ItoG3; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 15, ItoG3; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 18, ItoG3; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 21, ItoG3; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 24, ItoG3; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 30, ItoG3; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 36, ItoG3; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 42, ItoG3; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 48, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 54, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 60, ItoG3I; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 66, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 72, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 78, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 84, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | WD/study conclusion, ItoG3; n=50 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Worst-case on-therapy, ItoG3; n=65 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 1, ItoG4; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 2, ItoG4; n=57 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 3, ItoG4; n=61 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 6, ItoG4; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 9, ItoG4; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 12, ItoG4; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 15, ItoG4; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 18, ItoG4; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 21, ItoG4; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 24, ItoG4; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 30, ItoG4; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 36, ItoG4; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 42, ItoG4; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 48, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 54, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 60, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 66, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 72, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 78, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Week 84, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | WD/study conclusion, ItoG4; n=50 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points | Worst-case on-therapy, ItoG4; n=65 | 0 participants |
Secondary
Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points
Blood samples were collected for calcium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For calcium (low and high, respectively): G 1 (\<LLN to 8.0 mg/dL; \>ULN to 11.5x ULN), mild; G 2 (\<8.0 to 7.0 mg/dL; \>11.5 to 12.5 ULN), moderate; G 3 (\<7.0 to 6.0 mg/dL; \>12.5 to 13.5 mg/dL), severe; G 4 (\<6 mg/dL; \>13.5 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Population: Safety Population. Only those participants with data available at the specified time points were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 1, AGI; n=55 | 7 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 2, AGI; n=56 | 4 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 3, AGI; n=60 | 5 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 6, AGI; n=47 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 9, AGI; n=41 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 12, AGI; n=31 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 15, AGI; n=22 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 18, AGI; n=17 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 21, AGI; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 24, AGI; n=11 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 30, AGI; n=9 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 36, AGI; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 42, AGI; n=4 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 48, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 54, AGI; n=2 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 60, AGI; n=2 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 66, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 72, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 78, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 84, AGI; n=1 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | WD/study conclusion, AGI; n=49 | 12 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Worst-case on-therapy, AGI; n=65 | 23 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 1, ItoG3; n=55 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 2, ItoG3; n=56 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 3, ItoG3; n=60 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 6, ItoG3; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 9, ItoG3; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 12, ItoG3; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 15, ItoG3; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 18, ItoG3; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 21, ItoG3; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 24, ItoG3; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 30, ItoG3; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 36, ItoG3; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 42, ItoG3; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 48, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 54, ItoG3; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 60, ItoG3; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 66, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 72, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 78, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 84, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | WD/study conclusion, ItoG3; n=49 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Worst-case on-therapy, ItoG3; n=65 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 1, ItoG4; n=55 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 2, ItoG4; n=56 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 3, ItoG4; n=60 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 6, ItoG4; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 9, ItoG4; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 12, ItoG4; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 15, ItoG4; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 18, ItoG4; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 21, ItoG4; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 24, ItoG4; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 30, ItoG4; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 36, ItoG4; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 42, ItoG4; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 48, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 54, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 60, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 66, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 72, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 78, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Week 84, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | WD/study conclusion, ItoG4; n=49 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points | Worst-case on-therapy, ItoG4; n=65 | 0 participants |
Secondary
Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points
Blood samples were collected for the evaluation of creatinine. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For creatinine: G 1 (\>ULN to 1.5x ULN), mild; G 2 (\>1.5 to 3.0x ULN), moderate; G 3 (\>3.0 to 6.0x ULN), severe; G 4 (\>6.0x ULN), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Population: Safety Population. Only those participants with data available at the specified time points were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 1, AGI; n=54 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 2, AGI; n=56 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 3, AGI; n=61 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 6, AGI; n=47 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 9, AGI; n=40 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 12, AGI; n=31 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 15, AGI; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 18, AGI; n=17 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 21, AGI; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 24, AGI; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 30, AGI; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 36, AGI; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 42, AGI; n=4 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 48, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 54, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 60, AGI; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 66, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 72, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 78, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 84 AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | WD/study conclusion, AGI; n=50 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Worst-case on-therapy, AGI; n=65 | 6 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 1, ItoG3; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 2, ItoG3; n=56 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 3, ItoG3; n=61 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 6, ItoG3; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 9, ItoG3; n=40 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 12, ItoG3; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 15, ItoG3; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 18, ItoG3; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 21, ItoG3; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 24, ItoG3; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 30, ItoG3; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 36, ItoG3; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 42, ItoG3; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 48, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 54, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 60, ItoG3; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 66, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 72, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 78, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 84, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | WD/study conclusion, ItoG3; n=50 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Worst-case on-therapy, ItoG3; n=65 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 1, ItoG4; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 2, ItoG4; n=56 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 3, ItoG4; n=61 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 6, ItoG4; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 9, ItoG4; n=40 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 12, ItoG4; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 15, ItoG4; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 18, ItoG4; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 21, ItoG4; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 24, ItoG4; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 30, ItoG4; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 36, ItoG4; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 42, ItoG4; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 48, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 54, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 60, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 66, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 72, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 78, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Week 84, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | WD/study conclusion, ItoG4; n=50 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points | Worst-case on-therapy, ItoG4; n=65 | 0 participants |
Secondary
Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points
Blood samples were collected for the evaluation of glucose. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For glucose (high and low, respectively): G 1 (\>ULN to 160 mg/dL; \<LLN to 55 mg/dL), mild; G 2 (\>160 to 250 mg/dL; \<55 to 40 mg/dL), moderate; G 3 (\>250 to 500 mg/dL; \<40 to 30 mg/dL), severe; G 4 (\>500 mg/dL; \<30 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Population: Safety Population. Only those participants with data available at the specified time points were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 1, AGI; n=54 | 13 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 2, AGI; n=57 | 10 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 3, AGI; n=61 | 10 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 6, AGI; n=47 | 7 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 9, AGI; n=40 | 6 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 12, AGI; n=31 | 4 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 15, AGI; n=22 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 18, AGI; n=17 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 21, AGI; n=14 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 24, AGI; n=11 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 30, AGI; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 36, AGI; n=5 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 42, AGI; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 48, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 54, AGI; n=3 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 60, AGI; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 66, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 72, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 78, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 84, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | WD/study conclusion, AGI; n=49 | 15 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Worst-case on-therapy, AGI; n=65 | 32 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 1, ItoG3; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 2, ItoG3; n=57 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 3, ItoG3; n=61 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 6, ItoG3; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 9, ItoG3; n=40 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 12, ItoG3; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 15, ItoG3; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 18, ItoG3; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 21, ItoG3; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 24, ItoG3; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 30, ItoG3; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 36, ItoG3; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 42, ItoG3; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 48, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 54, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 60, ItoG3; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 66, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 72, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 78, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 84, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | WD/study conclusion, ItoG3; n=49 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Worst-case on-therapy, ItoG3; n=65 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 1, ItoG4; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 2, ItoG4; n=57 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 3, ItoG4; n=61 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 6, ItoG4; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 9, ItoG4; n=40 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 12, ItoG4; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 15, ItoG4; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 18, ItoG4; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 21, ItoG4; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 24, ItoG4; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 30, ItoG4; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 36, ItoG4; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 42, ItoG4; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 48, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 54, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 60, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 66, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 72, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 78, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Week 84, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | WD/study conclusion, ItoG4; n=49 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points | Worst-case on-therapy, ItoG4; n=65 | 0 participants |
Secondary
Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points
Blood samples were collected for the evaluation of hemoglobin. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For hemoglobin: G 1 (\<LLN to 10 g/dL), mild; G 2 (\<10.0 to 8.0 g/dL), moderate; G 3 (\<8.0 to 6.5 g/dL), severe; G 4 (\<6.5 g/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Population: Safety Population. Only those participants with data available at the specified time points were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 1, AGI; n=62 | 10 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 2, AGI; n=64 | 16 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 3, AGI; n=62 | 12 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 6, AGI; n=47 | 10 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 9, AGI; n=41 | 7 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 12, AGI; n=30 | 6 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 15, AGI; n=22 | 5 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 18, AGI; n=17 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 21, AGI; n=13 | 4 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 24, AGI; n=11 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 30, AGI; n=9 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 36, AGI; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 42, AGI; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 48, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 54, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 60, AGI; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 66, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 72, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 78, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 84, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Withdrawal/study conclusion, AGI; n=51 | 16 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Worst-case on-therapy, AGI; n=65 | 33 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 1, ItoG3; n=62 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 2, ItoG3; n=64 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 3, ItoG3; n=62 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 6, ItoG3; n=47 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 9, ItoG3; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 12, ItoG3; n=30 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 15, ItoG3; n=22 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 18, ItoG3; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 21, ItoG3; n=13 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 24, ItoG3; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 30, ItoG3; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 36, ItoG3; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 42, ItoG3; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 48, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 54, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 60, ItoG3; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 66, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 72, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 78, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 84, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Withdrawal/study conclusion, ItoG3; n=51 | 5 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Worst-case on-therapy, ItoG3; n=65 | 9 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 1, ItoG4; n=62 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 2, ItoG4; n=64 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 3, ItoG4; n=62 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 6, ItoG4; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 9, ItoG4; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 12, ItoG4; n=30 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 15, ItoG4; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 18, ItoG4; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 21, ItoG4; n=13 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 24, ItoG4; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 30, ItoG4; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 36, ItoG4; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 42, ItoG4; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 48, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 54, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 60, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 66, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 72, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 78, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Week 84, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Withdrawal/study conclusion, ItoG4; n=51 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points | Worst-case on-therapy, ItoG4; n=65 | 1 participants |
Secondary
Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points
Blood samples were collected for the evaluation of lymphocytes. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For lymphocytes: G 1, mild; G 2, moderate; G 3, severe; G 4, life threatening/disabling; G 5, death related to AE; ranges were provided by local laboratories. Change from Baseline was measured as any grade increase (AGI), increase to G 3 (ItoG3), and increase to G 4 (ItoG4). Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Population: Safety Population. Only those participants with data available at the specified time points were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 1, AGI; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 2, AGI; n=16 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 3, AGI; n=16 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 6, AGI; n=12 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 9, AGI; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 12, AGI; n=7 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 15, AGI; n=6 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 18, AGI; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 21, AGI; n=4 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 24, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 30, AGI; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 36, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 42, AGI; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 48, AGI; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 54, AGI; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 60, AGI; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 66, AGI; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 72, AGI; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 78, AGI; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 84, AGI; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Withdrawal/study conclusion, AGI; n=10 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Worst-case on-therapy, AGI; n=16 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 1, ItoG3; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 2, ItoG3; n=16 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 3, ItoG3; n=16 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 6, ItoG3; n=12 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 9, ItoG3; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 12, ItoG3; n=7 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 15, ItoG3; n=6 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 18, ItoG3; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 21, ItoG3; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 24, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 30, ItoG3; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 36, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 42, ItoG3; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 48, ItoG3; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 54, ItoG3; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 60, ItoG3; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 66, ItoG3; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 72, ItoG3; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 78, ItoG3; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 84, ItoG3; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Withdrawal/study conclusion, ItoG3; n=10 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Worst-case on-therapy, ItoG3; n=16 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 1, ItoG4; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 2, ItoG4; n=16 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 3, ItoG4; n=16 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 6, ItoG4; n=12 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 9, ItoG4; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 12, ItoG4; n=7 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 15, ItoG4; n=6 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 18, ItoG4; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 21, ItoG4; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 24, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 30, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 36, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 42, ItoG4; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 48, ItoG4; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 54, ItoG4; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 60, ItoG4; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 66, ItoG4; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 72, ItoG4; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 78, ItoG4; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Week 84, ItoG4; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Withdrawal/study conclusion, ItoG4; n=10 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points | Worst-case on-therapy, ItoG4; n=16 | 0 participants |
Secondary
Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points
Blood samples were collected for magnesium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For magnesium (high and low, respectively): G 1 (\>ULN to 3.0 mg/dL; \<LLN to 1.2 mg/dL), mild; G 2 (value not available; \<1.2 to 0.9 mg/dL), moderate; G 3 (\>3.0 to 8.0 mg/dL; \<0.9 to 0.7 mg/dL), severe; G 4 (\>8.0 mg/dL; \<0.7 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Population: Safety Population. Only those participants with data available at the specified time points were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 1, AGI; n=33 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 2, AGI; n=33 | 6 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 3, AGI; n=44 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 6, AGI; n=37 | 4 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 9, AGI; n=36 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 12, AGI; n=27 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 15, AGI; n=18 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 18, AGI; n=16 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 21, AGI; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 24, AGI; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 30, AGI; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 36, AGI; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 42, AGI; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 48, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 54, AGI; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 60, AGI; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 66, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 72, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 78, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 84, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | WD/study conclusion, AGI; n=35 | 6 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Worst-case on-therapy, AGI; n=59 | 17 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 1, ItoG3; n=33 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 2, ItoG3; n=33 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 3, ItoG3; n=44 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 6, ItoG3; n=37 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 9, ItoG3; n=36 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 12, ItoG3; n=27 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 15, ItoG3; n=18 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 18, ItoG3; n=16 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 21, ItoG3; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 24, ItoG3; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 30, ItoG3; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 36, ItoG3; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 42, ItoG3; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 48, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 54, ItoG3; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 60, ItoG3; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 66, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 72, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 78, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 84, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | WD/study conclusion, ItoG3; n=35 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Worst-case on-therapy, ItoG3; n=59 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 1, ItoG4; n=33 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 2, ItoG4; n=33 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 3, ItoG4; n=44 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 6, ItoG4; n=37 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 9, ItoG4; n=36 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 12, ItoG4; n=27 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 15, ItoG4; n=18 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 18, ItoG4; n=16 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 21, ItoG4; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 24, ItoG4; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 30, ItoG4; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 36, ItoG4; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 42, ItoG4; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 48, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 54, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 60, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 66, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 72, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 78, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Week 84, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | WD/study conclusion, ItoG4; n=35 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points | Worst-case on-therapy, ItoG4; n=59 | 0 participants |
Secondary
Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points
Blood samples were collected for the evaluation of platelet count. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For platelet count: G 1 (\<LLN to 75000/mm\^3 of blood plasma \[bp\]), mild; G 2 (\<75000 to 50000/mm\^3 of bp), moderate; G 3 (\<50000 to 25000/mm\^3 of bp), severe; G 4 (\<25000/mm\^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Population: Safety Population. Only those participants with data available at the specified time points were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 48, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 1, AGI; n=62 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 2, AGI; n=64 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 3, AGI; n=62 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 6, AGI; n=47 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 9, AGI; n=41 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 12, AGI; n=30 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 15, AGI; n=22 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 18, AGI; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 21, AGI; n=13 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 24, AGI; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 30, AGI; n=9 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 36, AGI; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 42, AGI; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 54, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 60, AGI; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 66, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 72, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 78, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 84, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Withdrawal/study conclusion, AGI; n=51 | 4 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Worst-case on-therapy, AGI; n=65 | 10 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 1, ItoG3; n=62 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 2, ItoG3; n=64 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 3, ItoG3; n=62 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 6, ItoG3; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 9, ItoG3; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 12, ItoG3; n=30 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 15, ItoG3; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 18, ItoG3; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 21, ItoG3; n=13 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 24, ItoG3; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 30, ItoG3; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 36, ItoG3; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 42, ItoG3; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 48, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 54, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 60, ItoG3; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 66, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 72, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 78, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 84, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Withdrawal/study conclusion, ItoG3; n=51 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Worst-case on-therapy, ItoG3; n=65 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 1, ItoG4; n=62 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 2, ItoG4; n=64 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 3, ItoG4; n=62 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 6, ItoG4; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 9, ItoG4; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 12, ItoG4; n=30 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 15, ItoG4; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 18, ItoG4; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 21, ItoG4; n=13 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 24, ItoG4; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 30, ItoG4; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 36, ItoG4; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 42, ItoG4; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 48, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 54, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 60, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 66, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 72, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 78, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Week 84, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Withdrawal/study conclusion, ItoG4; n=51 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points | Worst-case on-therapy, ItoG4; n=65 | 0 participants |
Secondary
Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points
Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For potassium (high and low \[per blood samples\], respectively): G 1 (\>ULN to 5.5 millimoles per liter \[mmol/L\]; \<LLN to 3.0 mmol/L), mild; G 2 (\>5.5 to 6.0 mmol/L; value not available), moderate; G 3 (\>6.0 to 7.0 mmol/L; \<3.0 to 2.5 mmol/L), severe; G 4 (\>7.0 mmol/L; \<2.5 mmol/L), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Population: Safety Population. Only those participants with data available at the specified time points were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 1, AGI; n=54 | 9 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 2, AGI; n=54 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 3, AGI; n=59 | 5 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 6, AGI; n=46 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 9, AGI; n=41 | 4 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 12, AGI; n=31 | 4 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 15, AGI; n=22 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 18, AGI; n=17 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 21, AGI; n=13 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 24, AGI; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 30, AGI; n=9 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 36, AGI; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 42, AGI; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 48, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 54, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 60, AGI; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 66, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 72, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 78, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 84, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | WD/study conclusion, AGI; n=48 | 7 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Worst-case on-therapy, AGI; n=65 | 25 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 1, ItoG3; n=54 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 2, ItoG3; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 3, ItoG3; n=59 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 6, ItoG3; n=46 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 9, ItoG3; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 12, ItoG3; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 15, ItoG3; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 18, ItoG3; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 21, ItoG3; n=13 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 24, ItoG3; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 30, ItoG3; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 36, ItoG3; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 42, ItoG3; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 48, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 54, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 60, ItoG3; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 66, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 72, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 78, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 84, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | WD/study conclusion, ItoG3; n=48 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Worst-case on-therapy, ItoG3; n=65 | 5 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 1, ItoG4; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 2, ItoG4; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 3, ItoG4; n=59 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 6, ItoG4; n=46 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 9, ItoG4; n=41 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 12, ItoG4; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 15, ItoG4; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 18, ItoG4; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 21, ItoG4; n=13 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 24, ItoG4; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 30, ItoG4; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 36, ItoG4; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 42, ItoG4; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 48, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 54, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 60, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 66, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 72, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 78, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Week 84, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | WD/study conclusion, ItoG4; n=48 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points | Worst-case on-therapy, ItoG4; n=65 | 1 participants |
Secondary
Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points
Blood samples were collected for sodium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of each AE severity. For sodium (high and low, respectively): G 1 (\>ULN to 150 mmol/L; \<LLN to 130 mmol/L), mild; G 2 (\>150 to 155 mmol/L; value not available), moderate; G 3 (\>155 to 160 mmol/L; \<130 to 120 mmol/L), severe; G 4 (\>160 mmol/L; \<120 mmol/L), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Population: Safety Population. Only those participants with data available at the specified time points were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 1, AGI; n=54 | 9 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 2, AGI; n=53 | 7 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 3, AGI; n=59 | 5 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 6, AGI; n=47 | 7 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 9, AGI; n=41 | 4 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 12, AGI; n=31 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 15, AGI; n=22 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 18, AGI; n=17 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 21, AGI; n=13 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 24, AGI; n=11 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 30, AGI; n=9 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 36, AGI; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 42, AGI; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 48, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 54, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 60, AGI; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 66, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 72, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 78, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 84, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | WD/study conclusion, AGI; n=48 | 10 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Worst-case on-therapy, AGI; n=65 | 28 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 1, ItoG3; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 2, ItoG3; n=53 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 3, ItoG3; n=59 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 6, ItoG3; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 9, ItoG3; n=41 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 12, ItoG3; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 15, ItoG3; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 18, ItoG3; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 21, ItoG3; n=13 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 24, ItoG3; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 30, ItoG3; n=9 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 36, ItoG3; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 42, ItoG3; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 48, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 54, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 60, ItoG3; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 66, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 72, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 78, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 84, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | WD/study conclusion, ItoG3; n=48 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Worst-case on-therapy, ItoG3; n=65 | 4 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 1, ItoG4; n=54 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 2, ItoG4; n=53 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 3, ItoG4; n=59 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 6, ItoG4; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 9, ItoG4; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 12, ItoG4; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 15, ItoG4; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 18, ItoG4; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 21, ItoG4; n=13 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 24, ItoG4; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 30, ItoG4; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 36, ItoG4; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 42, ItoG4; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 48, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 54, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 60, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 66, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 72, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 78, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Week 84, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | WD/study conclusion, ItoG4; n=48 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points | Worst-case on-therapy, ItoG4; n=65 | 1 participants |
Secondary
Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points
Blood samples were collected for the evaluation of total bilirubin. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For total bilirubin: G 1 (\>ULN to 1.5x ULN), mild; G 2 (\>1.5 to 3.0x ULN), moderate; G 3 (\>3.0 to 10.0x ULN), severe; G 4 (\>10.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Population: Safety Population. Only those participants with data available at the specified time points were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 1, AGI; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 2, AGI; n=57 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 3, AGI; n=61 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 6, AGI; n=47 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 9, AGI; n=41 | 8 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 12, AGI; n=31 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 15, AGI; n=22 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 18, AGI; n=17 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 21, AGI; n=14 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 24, AGI; n=11 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 30, AGI; n=9 | 4 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 36, AGI; n=5 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 42, AGI; n=4 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 48, AGI; n=3 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 54, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 60, AGI; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 66, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 72, AGI; n=1 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 78, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 84, AGI; n=1 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | WD/study conclusion, AGI; n=50 | 4 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Worst-case on-therapy, AGI; n=65 | 13 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 1, ItoG3; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 2, ItoG3; n=57 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 3, ItoG3; n=61 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 6, ItoG3; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 9, ItoG3; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 12, ItoG3; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 15, ItoG3; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 18, ItoG3; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 21, ItoG3; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 24, ItoG3; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 30, ItoG3; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 36, ItoG3; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 42, ItoG3; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 48, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 54, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 60, ItoG3I; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 66, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 72, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 78, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 84, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | WD/study conclusion, ItoG3; n=50 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Worst-case on-therapy, ItoG3; n=65 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 1, ItoG4; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 2, ItoG4; n=57 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 3, ItoG4; n=61 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 6, ItoG4; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 9, ItoG4; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 12, ItoG4; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 15, ItoG4; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 18, ItoG4; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 21, ItoG4; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 24, ItoG4; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 30, ItoG4; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 36, ItoG4; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 42, ItoG4; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 48, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 54, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 60, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 66, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 72, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 78, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Week 84, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | WD/study conclusion, ItoG4; n=50 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points | Worst-case on-therapy, ItoG4; n=65 | 0 participants |
Secondary
Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points
Blood samples were collected for the evaluation of total neutrophils. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For neutrophils: G 1 (\<LLN to 1500/millimeters cubed \[mm\^3\] of blood plasma \[bp\]), mild; G 2 (\<1500 to 1000/mm\^3 of bp), moderate; G 3 (\<1000 to 500/mm\^3 of bp), severe; G 4 (\<500/mm\^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Population: Safety Population. Only those participants with data available at the specified time points were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 78, AGI; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 84, AGI; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Withdrawal/study conclusion,, AGI; n=12 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Worst-case on-therapy, AGI; n=17 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 1, ItoG3; n=15 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 2, ItoG3; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 3, ItoG3; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 6, ItoG3; n=12 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 9, ItoG3; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 12, ItoG3; n=7 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 15, ItoG3; n=6 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 18, ItoG3; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 21, ItoG3; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 24, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 30, ItoG3; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 36, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 42, ItoG3; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 48, ItoG3; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 54, ItoG3; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 60, ItoG3; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 66, ItoG3; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 72, ItoG3; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 78, ItoG3; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 84, ItoG3; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Withdrawal/study conclusion, ItoG3; n=12 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Worst-case on-therapy, ItoG3; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 1, ItoG4; n=15 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 2, ItoG4; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 3, ItoG4; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 6, ItoG4; n=12 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 9, ItoG4; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 12, ItoG4; n=7 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 15, ItoG4; n=6 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 18, ItoG4; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 21, ItoG4; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 24, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 30, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 36, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 42, ItoG4; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 48, ItoG4; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 54, ItoG4; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 60, ItoG4; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 66, ItoG4; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 72, ItoG4; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 78, ItoG4; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 84, ItoG4; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Withdrawal/study conclusion, ItoG4; n=12 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Worst-case on-therapy, ItoG4; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 1, AGI; n=15 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 2, AGI; n=17 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 3, AGI; n=17 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 6, AGI; n=12 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 9, AGI; n=11 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 12, AGI; n=7 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 15, AGI; n=6 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 18, AGI; n=5 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 21, AGI; n=4 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 24, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 30, AGI; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 36, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 42, AGI; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 48, AGI; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 54, AGI; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 60, AGI; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 66, AGI; n=0 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points | Week 72, AGI; n=0 | 0 participants |
Secondary
Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points
Blood samples were collected for the evaluation of WBC count. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For WBCs: G 1 (\<LLN to 3000/mm\^3 of blood plasma \[bp\]), mild; G 2 (\<3000 to 2000/mm\^3 of bp), moderate; G 3 (\<2000 to 1000/mm\^3 of bp), severe; G 4 (\<1000/mm\^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Population: Safety Population. Only those participants with data available at the specified time points were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 1, AGI; n=62 | 5 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 2, AGI; n=64 | 9 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 3, AGI; n=62 | 6 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 6, AGI; n=47 | 5 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 9, AGI; n=41 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 12, AGI; n=30 | 7 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 15, AGI; n=22 | 4 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 18, AGI; n=17 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 21, AGI; n=13 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 24, AGI; n=11 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 30, AGI; n=9 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 36, AGI; n=5 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 42, AGI; n=4 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 48, AGI; n=3 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 54, AGI; n=3 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 60, AGI; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 66, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 72, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 78, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 84, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Withdrawal/study conclusion, AGI; n=51 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Worst-case on-therapy, AGI; n=65 | 17 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 1, ItoG3; n=62 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 2, ItoG3; n=64 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 3, ItoG3; n=62 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 6, ItoG3; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 9, ItoG3; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 12, ItoG3; n=30 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 15, ItoG3; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 18, ItoG3; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 21, ItoG3; n=13 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 24, ItoG3; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 30, ItoG3; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 36, ItoG3; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 42, ItoG3; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 48, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 54, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 60, ItoG3; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 66, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 72, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 78, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 84, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Withdrawal/study conclusion, ItoG3; n=51 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Worst-case on-therapy, ItoG3; n=65 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 1, ItoG4; n=62 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 2, ItoG4; n=64 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 3, ItoG4; n=62 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 6, ItoG4; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 9, ItoG4; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 12, ItoG4; n=30 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 15, ItoG4; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 18, ItoG4; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 21, ItoG4; n=13 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 24, ItoG4; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 30, ItoG4; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 36, ItoG4; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 42, ItoG4; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 48, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 54, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 60, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 66, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 72, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 78, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Week 84, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Withdrawal/study conclusion, ItoG4; n=51 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points | Worst-case on-therapy, ItoG4; n=65 | 0 participants |
Secondary
Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points
Toxicity was measured in grades (AE severity) per National Cancer Institute Common Toxicity Criteria for Adverse Event (NCI CTCAE) version (v) 3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For albumin (per blood samples): G 1 (\<lower limit of normal \[LLN\] to 3 grams per deciliter \[g/dL\]), mild; G 2 (\<3 to 2 g/dL), moderate; G 3 (\<2 g/dL), severe; G 4 (value not available), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.
Time frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy
Population: Safety Population: all participants who entered the study and received at least one dose of lapatinib. Only those participants with data available at the specified time points were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 1, AGI; n=54 | 10 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 2, AGI; n=57 | 9 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 3, AGI; n=61 | 10 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 6, AGI; n=47 | 4 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 9, AGI; n=41 | 2 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 12, AGI; n=31 | 4 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 15, AGI; n=22 | 3 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 18, AGI; n=17 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 21, AGI; n=14 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 24, AGI; n=11 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 30, AGI; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 36, AGI; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 42, AGI; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 48, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 54, AGI; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 60, AGI; n=2 | 1 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 66, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 72, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 78, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 84, AGI; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Withdrawal /study conclusion, AGI; n=50 | 11 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Worst-case on-therapy, AGI; n=65 | 29 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 1, ItoG3; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 2, ItoG3; n=57 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 3, ItoG3; n=61 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 6, ItoG3; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 9, ItoG3; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 12, ItoG3; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 15, ItoG3; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 18, ItoG3; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 21, ItoG3; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 24, ItoG3; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 30, ItoG3; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 36, ItoG3; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 42, ItoG3; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 48, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 54, ItoG3; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 60, ItoG3; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 66, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 72, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 78, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 84, ItoG3; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | WD/study conclusion, ItoG3; n=50 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Worst-case on-therapy, ItoG3; n=65 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 1, ItoG4; n=54 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 2, ItoG4; n=57 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 3, ItoG4; n=61 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 6, ItoG4; n=47 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 9, ItoG4; n=41 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 12, ItoG4; n=31 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 15, ItoG4; n=22 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 18, ItoG4; n=17 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 21, ItoG4; n=14 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 24, ItoG4; n=11 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 30, ItoG4; n=9 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 36, ItoG4; n=5 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 42, ItoG4; n=4 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 48, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 54, ItoG4; n=3 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 60, ItoG4; n=2 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 66, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 72, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 78, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Week 84, ItoG4; n=1 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | WD/study conclusion, ItoG4; n=50 | 0 participants |
| Lapatinib | Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points | Worst-case on-therapy ItoG4; n=65 | 0 participants |
Secondary
Overall Survival (OS)
Overall survival is defined as the time from the initial treatment until death due to any cause. A death occurring during the study is defined as a death occurring during treatment or within 30 days of the last administration of study medication.
Time frame: From Baseline (Day 0) until death due to any cause evaluated at approximately 12 months (up to approximately 100 weeks)
Population: ITT Population. OS was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lapatinib | Overall Survival (OS) | 27.6 weeks |
Secondary
PFS
PFS is defined as the time from the initial treatment until the first observation of disease progression or death due to any cause. The date of documented disease progression was defined as the earliest date of radiographic disease assessment progression or symptomatic progression, whichever came first. For participants who did not die/progress, survival was censored at the time of the last assessment (or contact).
Time frame: From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)
Population: ITT Population. PFS was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lapatinib | PFS | 14.3 weeks |
Secondary
Time to Progression (All Deaths Are Treated as Competing Risk)
Time to progression is defined as the time from the initial treatment (first dose) until the first documented radiological symptomatic sign of disease progression. Time to progression data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of the occurrence of a particular event is reached to a particular point. All factors that hinder the observation of the event are defined as competing risks.
Time frame: From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)
Population: ITT Population. Time to progression was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lapatinib | Time to Progression (All Deaths Are Treated as Competing Risk) | 18.9 weeks |
Secondary
Time to Progression (All Deaths Due to Non-PD Are Treated as Competing Risk)
Time to progression is defined as the time from the initial treatment (first dose) until the first documented radiological symptomatic sign of disease progression. Time to progression data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of occurrence of a particular event is reached to a particular point. All factors that hinder the observation of the event are defined as competing risks.
Time frame: From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)
Population: ITT Population. Time to progression was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lapatinib | Time to Progression (All Deaths Due to Non-PD Are Treated as Competing Risk) | 14.3 weeks |
Secondary
Time to Response
Time to response is defined as the time from the initial treatment until the first documented evidence of CR (disappearance of all TLs and non-TLs and the appearance of no new lesions) or PR (\>= a 30% decrease in the sum of the longest diameter of TLs, taking as reference the Baseline sum longest diameter) (whichever status was recorded first). Time to response data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of the occurrence of a particular event is reached to a particular point.
Time frame: Baseline (Day 0) until first documented evidence of response (up to approximately 60 weeks)
Population: ITT Population. Time to response was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lapatinib | Time to Response | NA weeks |