Trial Outcomes & Findings for Phase I/II Study of Lapatinib in Combination With Paclitaxel as 1L Chemotherapy for ErbB2-positive MBC (NCT NCT01138046)
NCT ID: NCT01138046
Last Updated: 2014-10-07
Results Overview
Investigational treatment was considered tolerable if one or more of the tolerability criteria were met by none or one of the 6 participants in the first cycle of Phase I. If one or more tolerability criteria were met by two or more participants, the issue was referred to the safety committee. Tolerability criteria for toxicities related to investigational treatment included grade 4 neutropenia persisting for 7 or more days, thrombocytopenia with a platelet count of less than or equal to 25,000/millimeter (mm)\^3 , clinically significant Grade 3 or 4 non-haematologic toxicities (excluding nausea) and inability to start cycle 2 within 2 weeks of scheduled dosing due to unresolved toxicity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
28 days
Results posted on
2014-10-07
Participant Flow
Six participants who met the eligibility criteria were enrolled into Phase I of the study. These 6 participants continued treatment into Phase II of the study, into which an additional 6 participants were enrolled. A total of 12 participants were followed until death or withdrawal from the study.
Participant milestones
| Measure |
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Participants received lapatinib 1500 milligrams (mg) once daily (QD) in combination with intravenous (IV) paclitaxel (80 milligrams per meters squared \[mg/m\^2\]) weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
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|---|---|
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Overall Study
STARTED
|
12
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Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
6
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Reasons for withdrawal
| Measure |
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Participants received lapatinib 1500 milligrams (mg) once daily (QD) in combination with intravenous (IV) paclitaxel (80 milligrams per meters squared \[mg/m\^2\]) weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
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|---|---|
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Overall Study
Withdrawal due to death
|
6
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Baseline Characteristics
Phase I/II Study of Lapatinib in Combination With Paclitaxel as 1L Chemotherapy for ErbB2-positive MBC
Baseline characteristics by cohort
| Measure |
Lapatinib 1500mg + Paclitaxel 80mg/m^2
n=12 Participants
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m\^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
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|---|---|
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Age, Continuous
|
58.1 Years
STANDARD_DEVIATION 7.76 • n=5 Participants
|
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Sex: Female, Male
Female
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12 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Asian - Japanese Heritage
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12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: All Subjects Population: all participants who received at least one dose of study medication and participated in Phase I of the study.
Investigational treatment was considered tolerable if one or more of the tolerability criteria were met by none or one of the 6 participants in the first cycle of Phase I. If one or more tolerability criteria were met by two or more participants, the issue was referred to the safety committee. Tolerability criteria for toxicities related to investigational treatment included grade 4 neutropenia persisting for 7 or more days, thrombocytopenia with a platelet count of less than or equal to 25,000/millimeter (mm)\^3 , clinically significant Grade 3 or 4 non-haematologic toxicities (excluding nausea) and inability to start cycle 2 within 2 weeks of scheduled dosing due to unresolved toxicity.
Outcome measures
| Measure |
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
n=6 Participants
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m\^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
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|---|---|
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Number of Participants With Intolerable Toxicities in Phase I of the Study
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1 Participants
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PRIMARY outcome
Timeframe: From the start of treatment until death due to any cause or study close, whichever occurred first (assessed up to a maximum of 1290 Days)Population: All Subjects Population: all participants who received at least one dose of study medication
Overall survival is defined as the time from the start of treatment until death due to any cause. For participants who survived, time to death was censored at the time of the last confirmation of survival.
Outcome measures
| Measure |
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
n=12 Participants
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m\^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
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|---|---|
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Overall Survival
|
35.6 Months
Interval 23.9 to
Due to an insufficient number of events the upper limit of the 95% confidence Interval could not be calculated.
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SECONDARY outcome
Timeframe: From the start of treatment until the earliest date of radiological disease progression or death due to any cause, whichever occured first (up to 1009 Days).Population: All Subjects Population. Participants who met the following criteria were censored: no Baseline assessment, no progression, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity or other reason, new anti-cancer treatment started, and death or progression after more than one missed visit.
PFS is defined as the interval between the start of treatment and the earliest date of radiological disease progression or death due to any cause, whichever occurred first. PFS was based on the investigator's assessment. For participants who survived, time to death was censored at the time of the last confirmation of survival.
Outcome measures
| Measure |
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
n=12 Participants
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m\^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
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|---|---|
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Progression-free Survival (PFS)
|
13.9 Months
Interval 7.6 to 27.9
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SECONDARY outcome
Timeframe: From the start of treatment until the first documented evidence of a PR or CR, whichever status is recorded first (up to 66 Days).Population: All Subjects Population. Only those participants with a CR or a PR were assessed.
Time to response is defined as the time from the start of treatment until first documented evidence of partial response (PR) or a complete response (CR) (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit.
Outcome measures
| Measure |
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
n=10 Participants
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m\^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
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|---|---|
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Time to Response
|
1.9 Months
Interval 1.8 to 1.9
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SECONDARY outcome
Timeframe: From the first documented evidence of a CR or a PR until the first documented sign of disease progression or death, whichever occurred earlier (up to 953 Days).Population: All Subjects Population. Only those participants with a CR or a PR were assessed. For participants who did not progress or die, duration of response was censored on the date of the last assessment.
Duration of response is defined as the time from the first documented evidence of a CR or a PR until the first documented sign of disease progression or death due to any cause (whichever occured earlier). The analysis was based on responses as evaluated by the investigator and was confirmed at a repeat assessment, with the duration of response taken from the first time the response was observed. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit.
Outcome measures
| Measure |
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
n=10 Participants
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m\^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
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|---|---|
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Duration of Response
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14.5 Months
Interval 9.1 to 26.3
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SECONDARY outcome
Timeframe: From the start of treatment until progressive disease/death (up to 1009 Days).Population: All Subjects Population. All participants who received at least one dose of study medication.
Best OR was defined as the best response recorded from the start of treatment until progressive disease (PD)/death as assessed by the investigator. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit. PD is defined as at least a 20% increase in the sum of the LD of target lesions or the appearance of 1 or more new lesions compared to the smallest sum LD recorded since the treatment started. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD compared to the smallest sum LD since the treatment started. Any participant who could not be classified by the four preceding definitions was considered Not evaluable.
Outcome measures
| Measure |
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
n=12 Participants
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m\^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
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|---|---|
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Number of Partcipants With a Best Overall Response (OR) as Determined by the Response Evaluation Criteria in Solid Tumors (RECIST)
CR
|
0 Participants
|
|
Number of Partcipants With a Best Overall Response (OR) as Determined by the Response Evaluation Criteria in Solid Tumors (RECIST)
PR
|
10 Participants
|
|
Number of Partcipants With a Best Overall Response (OR) as Determined by the Response Evaluation Criteria in Solid Tumors (RECIST)
SD
|
1 Participants
|
|
Number of Partcipants With a Best Overall Response (OR) as Determined by the Response Evaluation Criteria in Solid Tumors (RECIST)
PD
|
1 Participants
|
|
Number of Partcipants With a Best Overall Response (OR) as Determined by the Response Evaluation Criteria in Solid Tumors (RECIST)
Not evaluable
|
0 Participants
|
|
Number of Partcipants With a Best Overall Response (OR) as Determined by the Response Evaluation Criteria in Solid Tumors (RECIST)
Unkown
|
0 Participants
|
SECONDARY outcome
Timeframe: From the start of treatment until progressive disease/death (up to 1009 Days).Population: All Subjects Population. All participants who received at least one dose of study medication.
CBR is defined using RECIST as the number of participants who received at least one dose of study medication and achieved a best OR classified as CR, PR or SD for at least 6 months (24 weeks), i.e., CR + PR + SD for \>=24 weeks. CBR was based on confirmed responses by the investigator. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit. PD is defined as at least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions compared to the smallest sum LD recorded since the treatment started. SD is defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD compared to the smallest sum LD since the treatment started. Any participant who could not be classified by the the four preceding definitions was considered Not evaluable
Outcome measures
| Measure |
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
n=12 Participants
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m\^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
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|---|---|
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Number of Participants With Clinical Benefit Response (CBR)
Complete response
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0 Participants
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Number of Participants With Clinical Benefit Response (CBR)
Partial response
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10 Participants
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Number of Participants With Clinical Benefit Response (CBR)
Stable disease >=24 weeks
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0 Participants
|
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Number of Participants With Clinical Benefit Response (CBR)
Stable disease <=24 weeks
|
1 Participants
|
|
Number of Participants With Clinical Benefit Response (CBR)
Progressive disease
|
1 Participants
|
|
Number of Participants With Clinical Benefit Response (CBR)
Not evaluable
|
0 Participants
|
|
Number of Participants With Clinical Benefit Response (CBR)
Unknown
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 8 and Day 14 for lapatininb; Day 1 and Day 8 for paclitaxelPopulation: Pharmacokinetic (PK) Population: all participants who provided blood samples for PK evaluation
Cmax is defined as the maximum concentration of lapatinib and paclitaxel. Cmax was calculated from lapatinib plasma concentration-time data on Day 8 and Day 14 and paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses
Outcome measures
| Measure |
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
n=6 Participants
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m\^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
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|---|---|
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Maximum Plasma Concentration (Cmax) of Lapatinib and Paclitaxel
Lapatinib 1500 mg, Day 14
|
5945.022 Nanogram per milliliter ng/mL
Interval 3077.881 to 11482.989
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|
Maximum Plasma Concentration (Cmax) of Lapatinib and Paclitaxel
Lapatinib 1500 mg +Paclitaxel 80 mg/m^2, Day 8
|
9470.401 Nanogram per milliliter ng/mL
Interval 7157.899 to 12530.003
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|
Maximum Plasma Concentration (Cmax) of Lapatinib and Paclitaxel
Paclitaxel 80 mg/m^2, Day 1
|
3485.229 Nanogram per milliliter ng/mL
Interval 2693.037 to 4510.455
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Maximum Plasma Concentration (Cmax) of Lapatinib and Paclitaxel
Paclitaxel 80 mg/m2+ Lapatinib 1500 mg, Day 8
|
3412.332 Nanogram per milliliter ng/mL
Interval 2753.083 to 4229.443
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SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 8 and Day 14 for lapatininb; Day 1 and Day 8 for paclitaxelPopulation: PK Population: all participants who provided blood samples for PK evaluation
AUC is defined as the area under the lapatinib or paclitaxel concentration-time curve from time 0 to 24 hours (hrs). AUC (0-24) was calculated from lapatinib plasma concentration-time data on Day 8 and Day 14 and paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses
Outcome measures
| Measure |
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
n=6 Participants
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m\^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
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|---|---|
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Area Under the Concentration-time Curve (AUC) (0-24) of Lapatinib and Paclitaxel
Lapatinib 1500 mg, Day 14
|
79518.047 hours * nanograms/milliliter (hr*ng/mL)
Interval 34664.607 to 182408.525
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|
Area Under the Concentration-time Curve (AUC) (0-24) of Lapatinib and Paclitaxel
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2, Day 8
|
113078.292 hours * nanograms/milliliter (hr*ng/mL)
Interval 74630.131 to 171334.285
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Area Under the Concentration-time Curve (AUC) (0-24) of Lapatinib and Paclitaxel
Paclitaxel 80 mg/m^2, Day 1
|
4657.218 hours * nanograms/milliliter (hr*ng/mL)
Interval 3942.63 to 5501.322
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|
Area Under the Concentration-time Curve (AUC) (0-24) of Lapatinib and Paclitaxel
Paclitaxel 80mg/m^2 + Lapatinib 1500 mg, Day 8
|
5786.123 hours * nanograms/milliliter (hr*ng/mL)
Interval 4667.5 to 7172.837
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxelPopulation: PK Population: all participants who provided blood samples for PK evaluation
AUC(0-INF) is area under the plasma concentration-time curve from time 0 extrapolated to infinity. AUC (0-INF) was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses
Outcome measures
| Measure |
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
n=6 Participants
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m\^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
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|---|---|
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AUC From Time Zero to Infinity (0-INF) of Paclitaxel
Paclitaxel 80 mg/m^2, Day 1
|
5125.908 hr*ng/mL
Interval 4371.289 to 6010.798
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|
AUC From Time Zero to Infinity (0-INF) of Paclitaxel
Paclitaxel 80mg/m^2 + Lapatinib 1500 mg, Day 8
|
6279.964 hr*ng/mL
Interval 5005.596 to 7878.773
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SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 8 and Day 14 for lapatininb; Day 1 and Day 8 for paclitaxelPopulation: PK Population: all participants who provided blood samples for PK evaluation
Tmax is defined as the time to peak concentration from initiation of lapatinib and paclitaxel dosing. Tmax was calculated from lapatinib plasma concentration-time data on Day 8 and Day 14 and paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses
Outcome measures
| Measure |
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
n=6 Participants
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m\^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
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|---|---|
|
Time to the Maximum Drug Concentration (Tmax) of Lapatinib and Paclitaxel
Lapatinib 1500 mg, Day 14
|
4.992 Hr
Interval 1.5 to 6.08
|
|
Time to the Maximum Drug Concentration (Tmax) of Lapatinib and Paclitaxel
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2, Day 8
|
4.975 Hr
Interval 1.95 to 6.0
|
|
Time to the Maximum Drug Concentration (Tmax) of Lapatinib and Paclitaxel
Paclitaxel 80 mg/m^2, Day 1
|
0.992 Hr
Interval 0.95 to 1.08
|
|
Time to the Maximum Drug Concentration (Tmax) of Lapatinib and Paclitaxel
Paclitaxel 80mg/m^2 + Lapatinib 1500 mg, Day 8
|
0.975 Hr
Interval 0.5 to 1.02
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxelPopulation: PK Population: all participants who provided blood samples for PK evaluation
Vss is the volume of distribution at steady state of paclitaxel. Vss was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses
Outcome measures
| Measure |
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
n=6 Participants
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m\^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
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|---|---|
|
Distribution Volume at Steady State (Vss) of Paclitaxel
Paclitaxel 80 mg/m^2, Day 1
|
98909.326 milliliter per meters squared (mL/m^2)
Interval 73404.017 to 133276.831
|
|
Distribution Volume at Steady State (Vss) of Paclitaxel
Paclitaxel 80mg/m^2 + Lapatinib 1500 mg, Day 8
|
77460.104 milliliter per meters squared (mL/m^2)
Interval 63942.34 to 93835.598
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxelPopulation: PK Population: all participants who provided blood samples for PK evaluation
Half-life is defined as the time required for the amount of the drug in the plasma to decrease by half. T1/2 was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses
Outcome measures
| Measure |
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
n=6 Participants
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m\^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
|
|---|---|
|
Half-life (t1/2) of Paclitaxel
Paclitaxel 80 mg/m^2, Day 1
|
12.186 Hr
Interval 10.055 to 14.768
|
|
Half-life (t1/2) of Paclitaxel
Paclitaxel 80mg/m^2 + Lapatinib 1500 mg, Day 8
|
9.855 Hr
Interval 8.477 to 11.457
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxelPopulation: PK Population: all participants who provided blood samples for PK evaluation.
CL is defined as the volume of plasma in the vascular compartment cleared of drug per unit time by the processes of metabolism and excretion. CL was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses
Outcome measures
| Measure |
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
n=6 Participants
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m\^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
|
|---|---|
|
Drug Clearance (CL) of Paclitaxel
Paclitaxel 80 mg/m^2, Day 1
|
15606.990 mL/hour/m^2
Interval 13309.38 to 18301.238
|
|
Drug Clearance (CL) of Paclitaxel
Paclitaxel 80mg/m^2 + Lapatinib 1500 mg, Day 8
|
12738.926 mL/hour/m^2
Interval 10153.865 to 15982.114
|
Adverse Events
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
n=12 participants at risk
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m\^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
|
|---|---|
|
Investigations
Neutrophil count decreased
|
16.7%
2/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Cardiac disorders
Left ventricular dysfunction
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
Other adverse events
| Measure |
Lapatinib 1500 mg + Paclitaxel 80 mg/m^2
n=12 participants at risk
Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m\^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
91.7%
11/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
66.7%
8/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
6/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Nausea
|
41.7%
5/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
3/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Cheilitis
|
16.7%
2/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Dental caries
|
16.7%
2/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Haemorrhoids
|
16.7%
2/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Gastritis
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Glossitis
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Periproctitis
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Proctalgia
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Toothache
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Haemoglobin decreased
|
83.3%
10/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Alanine aminotransferase increased
|
58.3%
7/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
6/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Haematocrit decreased
|
50.0%
6/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
41.7%
5/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Weight decreased
|
33.3%
4/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Blood albumin decreased
|
25.0%
3/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Neutrophil count decreased
|
25.0%
3/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
White blood cell count decreased
|
25.0%
3/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Basophil count decreased
|
16.7%
2/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Blood bilirubin increased
|
16.7%
2/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Monocyte count decreased
|
16.7%
2/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Platelet count increased
|
16.7%
2/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Red blood cell count decreased
|
16.7%
2/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Blood glucose increased
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Blood potassium decreased
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Blood potassium increased
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Blood urea increased
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Electrocardiogram QT prolonged
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Eosinophil count decreased
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
Neutrophil count increased
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Investigations
White blood cell count increased
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
12/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
8/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
50.0%
6/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
2/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
2/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
16.7%
2/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Acne
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Keratolysis exfoliativa acquired
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
66.7%
8/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Nervous system disorders
Dysgeusia
|
41.7%
5/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Nervous system disorders
Hypoaesthesia
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Nervous system disorders
Somnolence
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
66.7%
8/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
8/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
50.0%
6/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Blood and lymphatic system disorders
Erythropenia
|
25.0%
3/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
General disorders
Fatigue
|
66.7%
8/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
General disorders
Oedema
|
25.0%
3/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
General disorders
Oedema peripheral
|
25.0%
3/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
General disorders
Pyrexia
|
25.0%
3/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
General disorders
Mucosal inflammation
|
16.7%
2/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
General disorders
Discomfort
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
General disorders
Feeling drunk
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
General disorders
Feeling hot
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
General disorders
Injection site reaction
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
General disorders
Malaise
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Infections and infestations
Paronychia
|
58.3%
7/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
6/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Infections and infestations
Gingivitis
|
16.7%
2/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Infections and infestations
Bronchitis
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Infections and infestations
Cystitis
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Infections and infestations
Erysipelas
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Infections and infestations
Folliculitis
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Infections and infestations
Influenza
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Infections and infestations
Nail infection
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Infections and infestations
Subcutaneous abscess
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
58.3%
7/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
41.7%
5/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
3/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
2/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
3/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
3/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
2/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Eye disorders
Blepharitis
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Eye disorders
Cataract
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Eye disorders
Erythema of eyelid
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Eye disorders
Eyelid oedema
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Eye disorders
Vision blurred
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Cardiac disorders
Cardiomegaly
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Cardiac disorders
Left ventricular dysfunction
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Ear and labyrinth disorders
Meniere's disease
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Renal and urinary disorders
Neurogenic bladder
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
|
Vascular disorders
Hot flush
|
8.3%
1/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until 30 days after the last dose (up to 1045 Days).
SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who had received at least one dose of the study medication.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER