Trial Outcomes & Findings for Study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib With Capecitabine for the Treatment of Metastatic Breast Cancer (NCT NCT02294786)
NCT ID: NCT02294786
Last Updated: 2019-07-15
Results Overview
Proportion of subjects experiencing at least one episode of diarrhoea with a severity of Grade 2 and above, as defined by the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03, recorded as AEs in the Electronic case report form (eCRF)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
Up to 24 weeks
Results posted on
2019-07-15
Participant Flow
The study enrolled 62 women in 17 centers; Czech Republic (1), Israel (1), Poland (3), the United Kingdom (4) Russian Federation (8)
The study was terminated early after 62 patients (out of 140 planned) were randomized as criteria for futility was met.
Participant milestones
| Measure |
Octreotide Treatment
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
No Octreotide Treatment
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
32
|
|
Overall Study
Safety Population
|
29
|
33
|
|
Overall Study
ITT Population
|
30
|
32
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
11
|
14
|
Reasons for withdrawal
| Measure |
Octreotide Treatment
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
No Octreotide Treatment
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Physician Decision
|
6
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Death
|
2
|
3
|
Baseline Characteristics
Study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib With Capecitabine for the Treatment of Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Octreotide Treatment
n=30 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
No Octreotide Treatment
n=32 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.4 Years
STANDARD_DEVIATION 10.07 • n=5 Participants
|
55.9 Years
STANDARD_DEVIATION 9.08 • n=7 Participants
|
56.6 Years
STANDARD_DEVIATION 9.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: ITT - For cycle 1-3 analysis: Subjects that withdrew from the study on or prior to the Cycle 4 visit date were assumed to have experienced diarrhoea. For the cycle 1-8 analysis: Subjects who did not have diarrhea event prior to the End of Study/Withdrawal visit date were not assumed to have experienced diarrhoea.
Proportion of subjects experiencing at least one episode of diarrhoea with a severity of Grade 2 and above, as defined by the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03, recorded as AEs in the Electronic case report form (eCRF)
Outcome measures
| Measure |
No Octreotide Treatment
n=32 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Octreotide Treatment
n=30 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
|---|---|---|
|
Proportion of Subjects Experiencing Diarrhoea of Grade 2 and Above (up to 24 Weeks)
Cyclce 1-3 (up to 9 weeks)with impuation
|
9 Participants
|
7 Participants
|
|
Proportion of Subjects Experiencing Diarrhoea of Grade 2 and Above (up to 24 Weeks)
Cyclce 1-8 (up to 24 weeks)without imputation
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT
Proportion of subjects experiencing diarrhoea with a severity of Grade 3 and above, as defined by the NCI CTCAE, version 4.03 and recorded as AEs in the eCRF
Outcome measures
| Measure |
No Octreotide Treatment
n=32 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Octreotide Treatment
n=30 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
|---|---|---|
|
Proportion of Subjects Experiencing Diarrhoea of Grade 3 and Above (up to 24 Weeks)
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT
Proportion of subjects experiencing diarrhoea of any grade of severity as defined by the NCI CTCAE, version 4.03 and recorded as AEs in the eCRF
Outcome measures
| Measure |
No Octreotide Treatment
n=32 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Octreotide Treatment
n=30 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
|---|---|---|
|
Proportion of Subjects Experiencing Diarrhoea of Any Grade of Severity (up to 24 Weeks)
|
14 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT - including only patients for whom an AE of diarrhoea and its duration was reported
Duration of diarrhoea of any grade of severity, recorded as AEs in the eCRF
Outcome measures
| Measure |
No Octreotide Treatment
n=13 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Octreotide Treatment
n=17 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
|---|---|---|
|
Duration of Diarrhoea of Any Grade of Severity
|
36.8 days
Standard Deviation 48.59
|
8.7 days
Standard Deviation 11.15
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT
Time to onset of the first episode of diarrhoea of any grade of severity, recorded as an AE in the eCRF. Subject are censored if there was no event. Median time and 95% confidence intervals were calculated using Kaplan-Meier estimates.
Outcome measures
| Measure |
No Octreotide Treatment
n=32 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Octreotide Treatment
n=30 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
|---|---|---|
|
Time to Onset of the First Episode of Diarrhoea of Any Grade of Severity
|
170 Days
Interval 104.0 to
There were not enough events to calculate the upper 95% CI.
|
NA Days
Interval 54.0 to
The median time to onset of first episode of diarrhea from the start of therapy was not reached.
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT
Proportion of subjects taking anti-diarrhoeal medication as recorded in the eCRF
Outcome measures
| Measure |
No Octreotide Treatment
n=32 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Octreotide Treatment
n=30 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
|---|---|---|
|
Proportion of Subjects Taking Anti-diarrhoeal Medication
|
11 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT - The information to calculate the proportions was not captured in the database.
Proportion of subjects making diarrhoea related unscheduled visits to healthcare professionals as recorded in the eCRF
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT
Proportion of subjects requiring diarrhoea related Lapatinib and Capecitabine dose reduction as recorded in the eCRF
Outcome measures
| Measure |
No Octreotide Treatment
n=32 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Octreotide Treatment
n=30 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
|---|---|---|
|
Proportion of Subjects Requiring Dose Reduction in Lapatinib and Capecitabine
Subjects requiring dose reduction in Lapatinib
|
0 Participants
|
1 Participants
|
|
Proportion of Subjects Requiring Dose Reduction in Lapatinib and Capecitabine
Subjects requiring dose reduction in Capecitabine
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT
Proportion of subjects requiring diarrhoea related Lapatinib and Capecitabine dose delay as recorded in the eCRF
Outcome measures
| Measure |
No Octreotide Treatment
n=32 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Octreotide Treatment
n=30 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
|---|---|---|
|
Proportion of Subjects Requiring Dose Delay in Lapatinib and Capecitabine
Subjects requiring dose delay in Lapatinib
|
2 Participants
|
2 Participants
|
|
Proportion of Subjects Requiring Dose Delay in Lapatinib and Capecitabine
Subjects requiring dose delay in Capecitabine
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT
Proportion of subjects requiring diarrhoea related Lapatinib and Capecitabine treatment withdrawal as recorded in the eCRF
Outcome measures
| Measure |
No Octreotide Treatment
n=32 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Octreotide Treatment
n=30 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
|---|---|---|
|
Proportion of Subjects Requiring Treatment Withdrawal in Lapatinib and Capecitabine
Requiring treatment withdrawal in Lapatinib
|
0 Participants
|
0 Participants
|
|
Proportion of Subjects Requiring Treatment Withdrawal in Lapatinib and Capecitabine
Requiring treatment withdrawal in Capecitabine
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT - The information to calculate the proportions was not captured in the database.
Proportion of subjects requiring use of diarrhoea-related intravenous fluids for rehydration as recorded in the eCRF
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT
Number of Lapatinib and Capecitabine tablets dispensed and returned as recorded in the eCRF
Outcome measures
| Measure |
No Octreotide Treatment
n=32 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Octreotide Treatment
n=30 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
|---|---|---|
|
Number of Lapatinib and Capecitabine Tablets Dispensed and Returned
Number of Lapatinib tablets dispensed
|
1115.6 tablets
Standard Deviation 495.9
|
1197.5 tablets
Standard Deviation 403.12
|
|
Number of Lapatinib and Capecitabine Tablets Dispensed and Returned
Number of Lapatinib tablets returned
|
403.3 tablets
Standard Deviation 238.47
|
477.1 tablets
Standard Deviation 173.94
|
|
Number of Lapatinib and Capecitabine Tablets Dispensed and Returned
Number of Capecitabine tablets dispensed
|
1011.2 tablets
Standard Deviation 532.06
|
1022.6 tablets
Standard Deviation 473.44
|
|
Number of Lapatinib and Capecitabine Tablets Dispensed and Returned
Number of Capecitabine tablets returned
|
210 tablets
Standard Deviation 196.64
|
186.1 tablets
Standard Deviation 157.19
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT
Overall response rate as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>=20% and \>= 5mm increase in the sum of diameters of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
No Octreotide Treatment
n=32 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Octreotide Treatment
n=30 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
|---|---|---|
|
Overall Response Rate (up to 24 Weeks)
complete response (CR)
|
2 Participants
|
0 Participants
|
|
Overall Response Rate (up to 24 Weeks)
partial response (PR)
|
4 Participants
|
6 Participants
|
|
Overall Response Rate (up to 24 Weeks)
stable disease (SD)
|
5 Participants
|
4 Participants
|
|
Overall Response Rate (up to 24 Weeks)
Progressive Disease
|
17 Participants
|
14 Participants
|
|
Overall Response Rate (up to 24 Weeks)
Not Evaluable
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT
Clinical benefit response as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Clinical Benefit Response rate (CBR) is defined as the percentage of subjects with a CR, PR or SD at week 24.
Outcome measures
| Measure |
No Octreotide Treatment
n=32 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Octreotide Treatment
n=30 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
|---|---|---|
|
Clinical Benefit Response (up to 24 Weeks)
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT
All subjects completed the baseline DMD during the 3 days prior to randomisation, before any study-related treatment is administered. Subjects randomised to receive Octreotide completed a second baseline DMD before starting the first cycle of treatment with Lapatinib and Capecitabine. The baseline DMD comprised of 3 questions to record stool form and consistency. The DMD to be completed throughout the rest of the study comprised of 3 questions in the baseline DMD and a further 5 questions and 6 sub-questions to evaluate the consequences and management of diarrhoea.
Outcome measures
| Measure |
No Octreotide Treatment
n=32 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Octreotide Treatment
n=30 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
|---|---|---|
|
Proportion of Subjects Reporting Changes in Bowel Movements From Baseline (Frequency and/or Consistency) as Recorded in the Diarrhoea Management Diary (DMD)
|
29 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT
Event is defined as Subjects reporting change in frequency and/or consistency of bowel movements from baseline at least once in DMD. Subject are censored if there is no change in bowel movement frequency/consistency as compared to baseline. Median time and 95% confidence intervals were calculated using Kaplan-Meier estimates.
Outcome measures
| Measure |
No Octreotide Treatment
n=32 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Octreotide Treatment
n=30 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
|---|---|---|
|
Time to the First Subject Reported Change in Frequency and/or Consistency of Bowel Movements From Baseline as Recorded in the DMD
|
8.0 Days
Interval 8.0 to 15.0
|
22.0 Days
Interval 16.0 to 57.0
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT
The proportion of subjects taking medication at least once as a result of diarrhoea are summarised
Outcome measures
| Measure |
No Octreotide Treatment
n=32 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Octreotide Treatment
n=30 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
|---|---|---|
|
Proportion of Subjects Taking Anti-diarrhoeal Medication as Recorded in the DMD
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT
The proportion of subjects making dietary changes to help with the diarrhoea are summarised
Outcome measures
| Measure |
No Octreotide Treatment
n=32 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Octreotide Treatment
n=30 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
|---|---|---|
|
Proportion of Subjects Making Dietary Changes Due to Diarrhoea as Recorded in the DMD
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT
The proportion of subjects contacting a health care professional other than the hospital doctors/nurses to discuss diarrhoea are summarised
Outcome measures
| Measure |
No Octreotide Treatment
n=32 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Octreotide Treatment
n=30 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
|---|---|---|
|
Proportion of Subjects Contacting Other Non-hospital Healthcare Professionals to Discuss Diarrhoea as Recorded in the DMD
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT
The proportion of subjects reducing or completely stopping the number of anti-cancer tablets to help with diarrhoea are summarised
Outcome measures
| Measure |
No Octreotide Treatment
n=32 Participants
Subjects randomised to receive no octreotide, treatment with Lapatinib and Capecitabine was initiated immediately following enrolment. All subjects received treatment with Lapatinib 1250mg once daily and Capecitabine 1000mg/m\^2 twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment
|
Octreotide Treatment
n=30 Participants
Subjects randomised to receive Octreotide were administered with Octreotide (Sandostatin LAR™) 40mg 7 days before the start of treatment with Lapatinib and Capecitabine and again 28 days later. All subjects received treatment with Lapatinib 1250milligram (mg) once daily and Capecitabine 1000 milligram/square meter (mg/m\^2) twice daily until disease progression. Lapatinib was given every day; Capecitabine was given in 3 week cycles of two weeks treatment followed by one week off treatment. SANDOSTATIN™ is a trademark of Novartis.
|
|---|---|---|
|
Proportion of Subjects Reporting Stopping Completely or Missing Doses of Anti-cancer Tablets Due to Diarrhoea as Recorded in the DMD
|
3 Participants
|
2 Participants
|
Adverse Events
Octreotide Treatment
Serious events: 5 serious events
Other events: 26 other events
Deaths: 1 deaths
No Octreotide Treatment
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
All Patients
Serious events: 8 serious events
Other events: 53 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Octreotide Treatment
n=29 participants at risk
Octreotide+Lap+Cap
|
No Octreotide Treatment
n=33 participants at risk
Lap+Cap
|
All Patients
n=62 participants at risk
All Patients
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
1/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
0.00%
0/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
1.6%
1/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Infections and infestations
Lower respiratory tract infection
|
3.4%
1/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
0.00%
0/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
1.6%
1/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Infections and infestations
Vulvitis
|
3.4%
1/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
0.00%
0/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
1.6%
1/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Investigations
Alanine aminotransferase increased
|
3.4%
1/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
0.00%
0/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
1.6%
1/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
3.0%
1/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
1.6%
1/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
3.0%
1/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
1.6%
1/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
3.0%
1/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
1.6%
1/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Vascular disorders
Thrombosis
|
3.4%
1/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
0.00%
0/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
1.6%
1/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
Other adverse events
| Measure |
Octreotide Treatment
n=29 participants at risk
Octreotide+Lap+Cap
|
No Octreotide Treatment
n=33 participants at risk
Lap+Cap
|
All Patients
n=62 participants at risk
All Patients
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.4%
1/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
18.2%
6/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
11.3%
7/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.4%
1/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
12.1%
4/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
8.1%
5/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.3%
3/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
9.1%
3/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
9.7%
6/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
2/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
0.00%
0/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
3.2%
2/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Gastrointestinal disorders
Diarrhoea
|
58.6%
17/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
45.5%
15/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
51.6%
32/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Gastrointestinal disorders
Dry mouth
|
6.9%
2/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
3.0%
1/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
4.8%
3/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.1%
2/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
3.2%
2/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Gastrointestinal disorders
Nausea
|
6.9%
2/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.1%
2/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.5%
4/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.1%
2/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
3.2%
2/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Gastrointestinal disorders
Stomatitis
|
6.9%
2/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.1%
2/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.5%
4/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
2/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
3.0%
1/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
4.8%
3/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
General disorders
Asthenia
|
6.9%
2/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
21.2%
7/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
14.5%
9/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
General disorders
Fatigue
|
10.3%
3/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
3.0%
1/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.5%
4/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
General disorders
Oedema peripheral
|
6.9%
2/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
0.00%
0/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
3.2%
2/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
6.9%
2/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.1%
2/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.5%
4/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Infections and infestations
Lower respiratory tract infection
|
10.3%
3/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
3.0%
1/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.5%
4/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Infections and infestations
Oral candidiasis
|
6.9%
2/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
0.00%
0/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
3.2%
2/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Infections and infestations
Paronychia
|
6.9%
2/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.1%
2/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.5%
4/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Investigations
Alanine aminotransferase increased
|
13.8%
4/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.1%
2/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
9.7%
6/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Investigations
Aspartate aminotransferase increased
|
13.8%
4/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
3.0%
1/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
8.1%
5/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Investigations
Bilirubin conjugated increased
|
6.9%
2/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
0.00%
0/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
3.2%
2/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Investigations
Blood bilirubin increased
|
13.8%
4/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
9.1%
3/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
11.3%
7/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.4%
1/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.1%
2/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
4.8%
3/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.1%
2/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
3.2%
2/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
2/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.1%
2/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.5%
4/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.1%
2/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
3.2%
2/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
2/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
9.1%
3/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
8.1%
5/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.1%
2/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
3.2%
2/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Skin and subcutaneous tissue disorders
Blister
|
6.9%
2/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
0.00%
0/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
3.2%
2/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
44.8%
13/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
33.3%
11/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
38.7%
24/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.8%
4/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
21.2%
7/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
17.7%
11/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
6.9%
2/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.1%
2/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.5%
4/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
|
Vascular disorders
Lymphoedema
|
3.4%
1/29 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
6.1%
2/33 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
4.8%
3/62 • Up to 28 weeks post randomization (from randomization until up to and including 4 weeks after the last dose of study treatment)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER