Trial Outcomes & Findings for Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib (NCT NCT03094052)
NCT ID: NCT03094052
Last Updated: 2025-06-26
Results Overview
Percentage of participants with clinically assessed grade 3 or greater diarrhea reported within the first 2 cycles (each cycle is 21 days) of neratinib while using anti-diarrheal strategies. Reports of diarrhea will be graded according to NCI CTCAE version 4.0.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Up to 6 weeks
Results posted on
2025-06-26
Participant Flow
Participant milestones
| Measure |
Adjuvant Neratinib, Crofelemer, Loperamide
Participants will receive 240mg neratinib to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 125mg of prophylactic Crofelemer and 4 mg of prophylactic loperamide as needed in the first 2 cycles.
|
Adjuvant Neratinib, Loperamide
Participants will receive 120 mg of neratinib on days 1-7 with subsequent increase in dose by 40 mg every 7 days until the full dose of 240 mg a day is reached within the first cycle (up to 240mg) to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 4 mg of prophylactic loperamide to be taken as needed.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
4
|
|
Overall Study
COMPLETED
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib
Baseline characteristics by cohort
| Measure |
Adjuvant Neratinib, Crofelemer, Loperamide
n=7 Participants
Participants will receive 240mg neratinib to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 125mg of prophylactic Crofelemer and 4 mg of prophylactic loperamide as needed in the first 2 cycles.
|
Adjuvant Neratinib, Loperamide
n=4 Participants
Participants will receive 120 mg of neratinib on days 1-7 with subsequent increase in dose by 40 mg every 7 days until the full dose of 240 mg a day is reached within the first cycle (up to 240mg) to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 4 mg of prophylactic loperamide to be taken as needed.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Customized
30-39 years old
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Customized
40-49 years old
|
6 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Customized
50-59 years old
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Customized
60-69 years old
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
4 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Hormone receptor positive (HR+)
|
7 participants
n=99 Participants
|
4 participants
n=107 Participants
|
11 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 6 weeksPercentage of participants with clinically assessed grade 3 or greater diarrhea reported within the first 2 cycles (each cycle is 21 days) of neratinib while using anti-diarrheal strategies. Reports of diarrhea will be graded according to NCI CTCAE version 4.0.
Outcome measures
| Measure |
Adjuvant Neratinib, Crofelemer, Loperamide
n=7 Participants
Participants will receive 240mg neratinib to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 125mg of prophylactic Crofelemer and 4 mg of prophylactic loperamide as needed in the first 2 cycles.
|
Adjuvant Neratinib, Loperamide
n=4 Participants
Participants will receive 120 mg of neratinib on days 1-7 with subsequent increase in dose by 40 mg every 7 days until the full dose of 240 mg a day is reached within the first cycle (up to 240mg) to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 4 mg of prophylactic loperamide to be taken as needed.
|
|---|---|---|
|
Percentage of Participants With Grade 3 or Greater Diarrhea
|
29 percentage of participants
|
50 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 55 weeksPercentage of participants who did not require loperamide during cancer treatment for at least 5 cycles will be reported.
Outcome measures
| Measure |
Adjuvant Neratinib, Crofelemer, Loperamide
n=7 Participants
Participants will receive 240mg neratinib to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 125mg of prophylactic Crofelemer and 4 mg of prophylactic loperamide as needed in the first 2 cycles.
|
Adjuvant Neratinib, Loperamide
n=4 Participants
Participants will receive 120 mg of neratinib on days 1-7 with subsequent increase in dose by 40 mg every 7 days until the full dose of 240 mg a day is reached within the first cycle (up to 240mg) to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 4 mg of prophylactic loperamide to be taken as needed.
|
|---|---|---|
|
Percentage of Participants Who Did Not Require Loperamide During Multiple Cycles of Treatment
|
71 percentage of participants
|
50 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 55 weeksThe percentage of participants who discontinued all anti-diarrheal medications during cancer treatment for at least 5 cycles will be reported.
Outcome measures
| Measure |
Adjuvant Neratinib, Crofelemer, Loperamide
n=7 Participants
Participants will receive 240mg neratinib to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 125mg of prophylactic Crofelemer and 4 mg of prophylactic loperamide as needed in the first 2 cycles.
|
Adjuvant Neratinib, Loperamide
n=4 Participants
Participants will receive 120 mg of neratinib on days 1-7 with subsequent increase in dose by 40 mg every 7 days until the full dose of 240 mg a day is reached within the first cycle (up to 240mg) to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 4 mg of prophylactic loperamide to be taken as needed.
|
|---|---|---|
|
Percentage of Participants Who Discontinued Anti-diarrheal Medications for Multiple Cycles of Treatment
|
43 percentage of participants
|
25 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 55 weeksPopulation: All participants experienced only Grade 1, Constipation related to anti-diarrhea medication. No other treatment-related adverse events were reported.
Percentage of participants with reported serious adverse events and adverse events of interest of any grade that have been determined to be related to the anti-diarrhea treatment will be reported by worst grade and associated toxicity.
Outcome measures
| Measure |
Adjuvant Neratinib, Crofelemer, Loperamide
n=7 Participants
Participants will receive 240mg neratinib to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 125mg of prophylactic Crofelemer and 4 mg of prophylactic loperamide as needed in the first 2 cycles.
|
Adjuvant Neratinib, Loperamide
n=4 Participants
Participants will receive 120 mg of neratinib on days 1-7 with subsequent increase in dose by 40 mg every 7 days until the full dose of 240 mg a day is reached within the first cycle (up to 240mg) to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 4 mg of prophylactic loperamide to be taken as needed.
|
|---|---|---|
|
Percentage of Participants With Treatment-related Adverse Events
|
100 percentage of participants
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 55 weeksThe number of participants who experienced a dose hold of neratinib during the course of study therapy will be reported
Outcome measures
| Measure |
Adjuvant Neratinib, Crofelemer, Loperamide
n=7 Participants
Participants will receive 240mg neratinib to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 125mg of prophylactic Crofelemer and 4 mg of prophylactic loperamide as needed in the first 2 cycles.
|
Adjuvant Neratinib, Loperamide
n=4 Participants
Participants will receive 120 mg of neratinib on days 1-7 with subsequent increase in dose by 40 mg every 7 days until the full dose of 240 mg a day is reached within the first cycle (up to 240mg) to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 4 mg of prophylactic loperamide to be taken as needed.
|
|---|---|---|
|
Number of Participants With Neratinib Dose Holds
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 55 weeksThe number of participants who discontinued neratinib earlier than expected during the course of study therapy will be reported
Outcome measures
| Measure |
Adjuvant Neratinib, Crofelemer, Loperamide
n=7 Participants
Participants will receive 240mg neratinib to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 125mg of prophylactic Crofelemer and 4 mg of prophylactic loperamide as needed in the first 2 cycles.
|
Adjuvant Neratinib, Loperamide
n=4 Participants
Participants will receive 120 mg of neratinib on days 1-7 with subsequent increase in dose by 40 mg every 7 days until the full dose of 240 mg a day is reached within the first cycle (up to 240mg) to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 4 mg of prophylactic loperamide to be taken as needed.
|
|---|---|---|
|
Number of Participants Who Discontinued Neratinib Early
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 55 weeksThe number of participants whose dose was reduced at any time during the course of therapy will be reported
Outcome measures
| Measure |
Adjuvant Neratinib, Crofelemer, Loperamide
n=7 Participants
Participants will receive 240mg neratinib to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 125mg of prophylactic Crofelemer and 4 mg of prophylactic loperamide as needed in the first 2 cycles.
|
Adjuvant Neratinib, Loperamide
n=4 Participants
Participants will receive 120 mg of neratinib on days 1-7 with subsequent increase in dose by 40 mg every 7 days until the full dose of 240 mg a day is reached within the first cycle (up to 240mg) to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 4 mg of prophylactic loperamide to be taken as needed.
|
|---|---|---|
|
Number of Participants With Neratinib Dose-reductions
|
3 Participants
|
2 Participants
|
Adverse Events
Adjuvant Neratinib, Crofelemer, Loperamide
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Adjuvant Neratinib, Loperamide
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adjuvant Neratinib, Crofelemer, Loperamide
n=7 participants at risk
Participants will receive 240mg neratinib to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 125mg of prophylactic Crofelemer and 4 mg of prophylactic loperamide as needed in the first 2 cycles.
|
Adjuvant Neratinib, Loperamide
n=4 participants at risk
Participants will receive 120 mg of neratinib on days 1-7 with subsequent increase in dose by 40 mg every 7 days until the full dose of 240 mg a day is reached within the first cycle (up to 240mg) to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Participants will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks. Participants will also receive 4 mg of prophylactic loperamide to be taken as needed.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
7/7 • Number of events 163 • Up to 55 weeks
|
100.0%
4/4 • Number of events 56 • Up to 55 weeks
|
|
Gastrointestinal disorders
Constipation
|
100.0%
7/7 • Number of events 68 • Up to 55 weeks
|
50.0%
2/4 • Number of events 2 • Up to 55 weeks
|
|
Gastrointestinal disorders
Nausea
|
71.4%
5/7 • Number of events 6 • Up to 55 weeks
|
100.0%
4/4 • Number of events 4 • Up to 55 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
57.1%
4/7 • Number of events 13 • Up to 55 weeks
|
25.0%
1/4 • Number of events 2 • Up to 55 weeks
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
3/7 • Number of events 4 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 2 • Up to 55 weeks
|
25.0%
1/4 • Number of events 2 • Up to 55 weeks
|
|
Gastrointestinal disorders
Bloating
|
28.6%
2/7 • Number of events 2 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
28.6%
2/7 • Number of events 2 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/7 • Up to 55 weeks
|
25.0%
1/4 • Number of events 1 • Up to 55 weeks
|
|
Gastrointestinal disorders
Flatulence
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Gastrointestinal disorders
Oral dysesthesia
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
25.0%
1/4 • Number of events 1 • Up to 55 weeks
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/7 • Up to 55 weeks
|
25.0%
1/4 • Number of events 1 • Up to 55 weeks
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
75.0%
3/4 • Number of events 3 • Up to 55 weeks
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
75.0%
3/4 • Number of events 3 • Up to 55 weeks
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
25.0%
1/4 • Number of events 1 • Up to 55 weeks
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/7 • Up to 55 weeks
|
25.0%
1/4 • Number of events 1 • Up to 55 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
General disorders
Fatigue
|
42.9%
3/7 • Number of events 6 • Up to 55 weeks
|
50.0%
2/4 • Number of events 2 • Up to 55 weeks
|
|
General disorders
Fever
|
28.6%
2/7 • Number of events 2 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
General disorders
Chills
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
General disorders
Flu like symptoms
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
25.0%
1/4 • Number of events 1 • Up to 55 weeks
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
14.3%
1/7 • Number of events 2 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
General disorders
Pain
|
0.00%
0/7 • Up to 55 weeks
|
25.0%
1/4 • Number of events 1 • Up to 55 weeks
|
|
Investigations
Weight loss
|
28.6%
2/7 • Number of events 2 • Up to 55 weeks
|
25.0%
1/4 • Number of events 1 • Up to 55 weeks
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Number of events 3 • Up to 55 weeks
|
25.0%
1/4 • Number of events 1 • Up to 55 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Number of events 4 • Up to 55 weeks
|
25.0%
1/4 • Number of events 1 • Up to 55 weeks
|
|
Investigations
Creatinine increased
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Investigations
Ejection fraction decreased
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
42.9%
3/7 • Number of events 4 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
28.6%
2/7 • Number of events 2 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/7 • Up to 55 weeks
|
25.0%
1/4 • Number of events 1 • Up to 55 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Infections and infestations
Infections and infestations - Other, specify
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Infections and infestations
Upper respiratory infection
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Infections and infestations
Vaginal infection
|
14.3%
1/7 • Number of events 2 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/7 • Up to 55 weeks
|
25.0%
1/4 • Number of events 1 • Up to 55 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Injury, poisoning and procedural complications
Fracture
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
42.9%
3/7 • Number of events 3 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 3 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Reproductive system and breast disorders
Vaginal discharge
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Reproductive system and breast disorders
Vaginal dryness
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/7 • Up to 55 weeks
|
25.0%
1/4 • Number of events 1 • Up to 55 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
2/7 • Number of events 4 • Up to 55 weeks
|
25.0%
1/4 • Number of events 1 • Up to 55 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Vascular disorders
Hot flashes
|
42.9%
3/7 • Number of events 3 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Vascular disorders
Lymphedema
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Cardiac disorders
Sinus bradycardia
|
14.3%
1/7 • Number of events 2 • Up to 55 weeks
|
25.0%
1/4 • Number of events 1 • Up to 55 weeks
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 1 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
14.3%
1/7 • Number of events 2 • Up to 55 weeks
|
0.00%
0/4 • Up to 55 weeks
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/7 • Up to 55 weeks
|
25.0%
1/4 • Number of events 1 • Up to 55 weeks
|
Additional Information
Dr. A. Jo Chien, MD
University of California, San Francisco
Phone: (415) 885-7577
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place