Trial Outcomes & Findings for Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients (NCT NCT02910219)
NCT ID: NCT02910219
Last Updated: 2022-10-24
Results Overview
Percentage of participants with any grade (based on CTCAE 4.0) diarrhea lasting 2 or more consecutive days during cycles 1 and 2 of chemotherapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Cycle 1, Cycle 2 (each cycle is 21 days)
Results posted on
2022-10-24
Participant Flow
Participant milestones
| Measure |
Crofelemer
Patients on the treatment arm will take one tablet of crofelemer twice a day (each tablet is 125 mg), to be swallowed whole without chewing or crushing, during cycles 1-2 of chemotherapy with THP or TCHP. Patient will be monitored off crofelemer during cycle 3 of chemotherapy.
Crofelemer: Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP
|
Control
Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
|
Overall Study
COMPLETED
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Crofelemer
Patients on the treatment arm will take one tablet of crofelemer twice a day (each tablet is 125 mg), to be swallowed whole without chewing or crushing, during cycles 1-2 of chemotherapy with THP or TCHP. Patient will be monitored off crofelemer during cycle 3 of chemotherapy.
Crofelemer: Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP
|
Control
Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Treatment
n=26 Participants
Patients on the treatment arm will take one tablet of crofelemer twice a day (each tablet is 125 mg), to be swallowed whole without chewing or crushing, during cycles 1-2 of chemotherapy with THP or TCHP. Patient will be monitored off crofelemer during cycle 3 of chemotherapy.
Crofelemer: Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP
|
Control
n=25 Participants
Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.9 years
n=5 Participants
|
52 years
n=7 Participants
|
52.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cycle 1, Cycle 2 (each cycle is 21 days)Percentage of participants with any grade (based on CTCAE 4.0) diarrhea lasting 2 or more consecutive days during cycles 1 and 2 of chemotherapy.
Outcome measures
| Measure |
Crofelemer
n=26 Participants
Patients on the treatment arm will take one tablet of crofelemer twice a day (each tablet is 125 mg), to be swallowed whole without chewing or crushing, during cycles 1-2 of chemotherapy with THP or TCHP. Patient will be monitored off crofelemer during cycle 3 of chemotherapy.
Crofelemer: Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP
|
Control
n=25 Participants
Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study.
|
|---|---|---|
|
Diarrhea for >= 2 Consecutive Days
Cycle 1
|
68 percentage of patients
|
69.6 percentage of patients
|
|
Diarrhea for >= 2 Consecutive Days
Cycle 2
|
65.2 percentage of patients
|
72.2 percentage of patients
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2 (each cycle is 21 days)Population: The number analyzed is different from overall number due to early treatment discontinuation.
Incidence of diarrhea of any grade, as measured by CTCAE v4.0, by cycle
Outcome measures
| Measure |
Crofelemer
n=26 Participants
Patients on the treatment arm will take one tablet of crofelemer twice a day (each tablet is 125 mg), to be swallowed whole without chewing or crushing, during cycles 1-2 of chemotherapy with THP or TCHP. Patient will be monitored off crofelemer during cycle 3 of chemotherapy.
Crofelemer: Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP
|
Control
n=25 Participants
Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study.
|
|---|---|---|
|
Diarrhea Any Grade
Cycle 1 (investigator-assessed)
|
16 Participants
|
16 Participants
|
|
Diarrhea Any Grade
Cycle 2 (investigator-assessed)
|
15 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2 (each cycle is 21 days)Population: The number analyzed is different from overall number due to early treatment discontinuation.
number of patients with diarrhea of grade 3 or grade 4, as measured by CTCAE v4.0, by cycle and by stratum
Outcome measures
| Measure |
Crofelemer
n=26 Participants
Patients on the treatment arm will take one tablet of crofelemer twice a day (each tablet is 125 mg), to be swallowed whole without chewing or crushing, during cycles 1-2 of chemotherapy with THP or TCHP. Patient will be monitored off crofelemer during cycle 3 of chemotherapy.
Crofelemer: Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP
|
Control
n=25 Participants
Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study.
|
|---|---|---|
|
Grade 3-4 Diarrhea
Cycle 1
|
1 Participants
|
2 Participants
|
|
Grade 3-4 Diarrhea
Cycle 2
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: from baseline through Cycle 3 (21 day cycles)Population: The number analyzed is different from overall number due to missing data.
Time to onset of first episode of diarrhea of any grade, overall
Outcome measures
| Measure |
Crofelemer
n=25 Participants
Patients on the treatment arm will take one tablet of crofelemer twice a day (each tablet is 125 mg), to be swallowed whole without chewing or crushing, during cycles 1-2 of chemotherapy with THP or TCHP. Patient will be monitored off crofelemer during cycle 3 of chemotherapy.
Crofelemer: Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP
|
Control
n=23 Participants
Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study.
|
|---|---|---|
|
Diarrhea Onset
|
3 days
Interval 1.0 to 4.0
|
2 days
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2 (each cycle is 21 days)Population: Duration of the "FIRST day of diarrhea" to the "LAST day of diarrhea" based on patient diary. Only Cycle 1 and Cycle 2 analyzed. The number analyzed is different from overall number due to missing data.
Duration (days) of any grade diarrhea, defined from day 1 to day 21, by cycle in which the episode started
Outcome measures
| Measure |
Crofelemer
n=25 Participants
Patients on the treatment arm will take one tablet of crofelemer twice a day (each tablet is 125 mg), to be swallowed whole without chewing or crushing, during cycles 1-2 of chemotherapy with THP or TCHP. Patient will be monitored off crofelemer during cycle 3 of chemotherapy.
Crofelemer: Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP
|
Control
n=23 Participants
Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study.
|
|---|---|---|
|
Diarrhea Duration
Cycle 1
|
13 days
Interval 8.0 to
NA = upper confidence limit of infinity
|
15 days
Interval 10.0 to
NA = upper confidence limit of infinity
|
|
Diarrhea Duration
Cycle 2
|
15 days
Interval 9.0 to
NA = upper confidence limit of infinity
|
12 days
Interval 9.0 to
NA = upper confidence limit of infinity
|
SECONDARY outcome
Timeframe: End of Cycle 2 (each cycle is 21 days)Duration (days) of grade 3-4 diarrhea during cycle 1 through the end of cycle 2, defined from cycle day 1 to cycle 2 day 21
Outcome measures
| Measure |
Crofelemer
n=1 Participants
Patients on the treatment arm will take one tablet of crofelemer twice a day (each tablet is 125 mg), to be swallowed whole without chewing or crushing, during cycles 1-2 of chemotherapy with THP or TCHP. Patient will be monitored off crofelemer during cycle 3 of chemotherapy.
Crofelemer: Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP
|
Control
n=4 Participants
Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study.
|
|---|---|---|
|
Duration Grade 3-4 Diarrhea
|
18 days
Interval 0.0 to 18.0
|
6.5 days
Interval 1.0 to 12.0
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2 (each cycle is 21 days)Population: Only cycle 1 and cycle 2 analyzed. Total amount of Loperamide, Diphenoxylate Atropine and Octreotide; No subjects in the Crofelemer arm received octreotide in either cycle 1 or 2.
Use of anti-diarrheal medications (other than study drug), by cycle and arm
Outcome measures
| Measure |
Crofelemer
n=26 Participants
Patients on the treatment arm will take one tablet of crofelemer twice a day (each tablet is 125 mg), to be swallowed whole without chewing or crushing, during cycles 1-2 of chemotherapy with THP or TCHP. Patient will be monitored off crofelemer during cycle 3 of chemotherapy.
Crofelemer: Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP
|
Control
n=22 Participants
Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study.
|
|---|---|---|
|
Anti-diarrheal Medications
Cycle 1- Loperamide
|
20.69 units
Standard Deviation 36.74
|
24.73 units
Standard Deviation 41.4
|
|
Anti-diarrheal Medications
Cycle 2-Loperamide
|
16.25 units
Standard Deviation 23.43
|
21.24 units
Standard Deviation 31.52
|
|
Anti-diarrheal Medications
Cycle 1-Diphenoxylate Atropine
|
16.15 units
Standard Deviation 82.36
|
2.272 units
Standard Deviation 12.79
|
|
Anti-diarrheal Medications
Cycle 2- Diophnoxylate Atropine
|
0.8333 units
Standard Deviation 3.18
|
5.595 units
Standard Deviation 25.64
|
|
Anti-diarrheal Medications
Cycle 1- Octreotide
|
0 units
Standard Deviation 0
|
6.818 units
Standard Deviation 31.98
|
|
Anti-diarrheal Medications
Cycle 2- Octreotide
|
0 units
Standard Deviation 0
|
71.43 units
Standard Deviation 327.3
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2 (each cycle is 21 days)Population: The number analyzed is different from overall number due to early treatment discontinuation.
Quantitative FACIT-D (FACIT-D Functional Assessment of Chronic Illness Therapy for Patients With Diarrhea) total score, collected day 1 of each cycle and at the time of study completion, cycles 1 and 2 reported; The higher the score the better the QOL; Score range 0-152.
Outcome measures
| Measure |
Crofelemer
n=26 Participants
Patients on the treatment arm will take one tablet of crofelemer twice a day (each tablet is 125 mg), to be swallowed whole without chewing or crushing, during cycles 1-2 of chemotherapy with THP or TCHP. Patient will be monitored off crofelemer during cycle 3 of chemotherapy.
Crofelemer: Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP
|
Control
n=25 Participants
Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study.
|
|---|---|---|
|
FACIT-D Total Score
Cycle 1
|
129.0 score on a scale
Standard Deviation 14.3
|
123.8 score on a scale
Standard Deviation 20.4
|
|
FACIT-D Total Score
Cycle 2
|
116.7 score on a scale
Standard Deviation 19.8
|
114.4 score on a scale
Standard Deviation 23.3
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2 (each cycle is 21 days)Population: The number analyzed is different from overall number due to early treatment discontinuation.
Quantitative FACIT-D (FACIT-D Functional Assessment of Chronic Illness Therapy for Patients With Diarrhea) diarrhea subscale (DS) score, by cycle; Score Range 0-44; the higher the score, the better the QOL.
Outcome measures
| Measure |
Crofelemer
n=26 Participants
Patients on the treatment arm will take one tablet of crofelemer twice a day (each tablet is 125 mg), to be swallowed whole without chewing or crushing, during cycles 1-2 of chemotherapy with THP or TCHP. Patient will be monitored off crofelemer during cycle 3 of chemotherapy.
Crofelemer: Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP
|
Control
n=25 Participants
Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study.
|
|---|---|---|
|
FACIT-D Diarrhea Score
Cycle 1
|
40.5 score on a scale
Standard Deviation 6.2
|
39.8 score on a scale
Standard Deviation 6.3
|
|
FACIT-D Diarrhea Score
Cycle 2
|
34.9 score on a scale
Standard Deviation 6.8
|
34.1 score on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2 (each cycle is 21 days)Population: The number analyzed is different from overall number due to early treatment discontinuation.
Frequency of stool consistency of 6-7, as measured by the Bristol Stool scale (minimum 1-separate hard lumps, maximum 7-watery, no solid pieces), by cycle; Median in watery bowel movements (Bristol Stool Form Scale 6-7).
Outcome measures
| Measure |
Crofelemer
n=26 Participants
Patients on the treatment arm will take one tablet of crofelemer twice a day (each tablet is 125 mg), to be swallowed whole without chewing or crushing, during cycles 1-2 of chemotherapy with THP or TCHP. Patient will be monitored off crofelemer during cycle 3 of chemotherapy.
Crofelemer: Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP
|
Control
n=25 Participants
Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study.
|
|---|---|---|
|
Stool Frequency Based on Consistency (Bristol Stool Scale)
Cycle 1
|
14.5 number of bowel movements
Interval 0.0 to 102.0
|
19 number of bowel movements
Interval 4.0 to 72.0
|
|
Stool Frequency Based on Consistency (Bristol Stool Scale)
Cycle 2
|
14.0 number of bowel movements
Interval 0.0 to 139.0
|
17.5 number of bowel movements
Interval 1.0 to 75.0
|
Adverse Events
Crofelemer
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Control
Serious events: 7 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Crofelemer
n=26 participants at risk
Patients on the treatment arm will take one tablet of crofelemer twice a day (each tablet is 125 mg), to be swallowed whole without chewing or crushing, during cycles 1-2 of chemotherapy with THP or TCHP. Patient will be monitored off crofelemer during cycle 3 of chemotherapy.
Crofelemer: Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP
|
Control
n=25 participants at risk
Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study.
|
|---|---|---|
|
Investigations
Neutrophil count decreased
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/26 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/26 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/26 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/26 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/26 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/26 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Psychiatric disorders
Confusion
|
0.00%
0/26 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
General disorders
Fatigue
|
0.00%
0/26 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/26 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Cardiac disorders
chest pain
|
0.00%
0/26 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/26 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
General disorders
Fever
|
0.00%
0/26 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
Other adverse events
| Measure |
Crofelemer
n=26 participants at risk
Patients on the treatment arm will take one tablet of crofelemer twice a day (each tablet is 125 mg), to be swallowed whole without chewing or crushing, during cycles 1-2 of chemotherapy with THP or TCHP. Patient will be monitored off crofelemer during cycle 3 of chemotherapy.
Crofelemer: Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP
|
Control
n=25 participants at risk
Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
19.2%
5/26 • Number of events 8 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
12.0%
3/25 • Number of events 5 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Gastrointestinal disorders
Constipation
|
15.4%
4/26 • Number of events 4 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
12.0%
3/25 • Number of events 3 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Gastrointestinal disorders
Diarrhea
|
69.2%
18/26 • Number of events 116 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
88.0%
22/25 • Number of events 93 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
15.4%
4/26 • Number of events 4 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Gastrointestinal disorders
Mucositis oral
|
15.4%
4/26 • Number of events 4 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
12.0%
3/25 • Number of events 3 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Gastrointestinal disorders
Nausea
|
38.5%
10/26 • Number of events 12 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
48.0%
12/25 • Number of events 15 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
3/26 • Number of events 3 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
General disorders
Fatigue
|
38.5%
10/26 • Number of events 12 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
36.0%
9/25 • Number of events 10 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
General disorders
Infusion related reaction
|
0.00%
0/26 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
12.0%
3/25 • Number of events 3 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
General disorders
Pain
|
11.5%
3/26 • Number of events 4 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
12.0%
3/25 • Number of events 3 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
2/26 • Number of events 6 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
2/26 • Number of events 4 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Metabolism and nutrition disorders
Anorexia
|
15.4%
4/26 • Number of events 6 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
12.0%
3/25 • Number of events 3 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/26 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
16.0%
4/25 • Number of events 4 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.7%
2/26 • Number of events 4 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.5%
3/26 • Number of events 5 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 2 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.5%
3/26 • Number of events 3 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Nervous system disorders
Dysgeusia
|
11.5%
3/26 • Number of events 5 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Nervous system disorders
Headache
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.5%
3/26 • Number of events 3 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
16.0%
4/25 • Number of events 5 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Psychiatric disorders
Anxiety
|
15.4%
4/26 • Number of events 4 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
0.00%
0/25 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
12.0%
3/25 • Number of events 3 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
11.5%
3/26 • Number of events 3 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
4.0%
1/25 • Number of events 2 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.5%
3/26 • Number of events 3 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
8.0%
2/25 • Number of events 3 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Investigations
Weight loss
|
0.00%
0/26 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
8.0%
2/25 • Number of events 2 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
|
Vascular disorders
Hypertension
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
0.00%
0/25 • Adverse events were collected from signing consent to 30 days after completing study or 30 days after last dose of crofelemer, whichever occurs later (until cycle 4 day 1).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place