Trial Outcomes & Findings for Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients With Stage I-III HER2 Positive Breast Cancer (NCT NCT04249622)
NCT ID: NCT04249622
Last Updated: 2025-09-16
Results Overview
Based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner (1987).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Through study completion (approximately 2 years, 3 months)
Results posted on
2025-09-16
Participant Flow
Participant milestones
| Measure |
Arm I (Rifaximin, Pertuzumab-based Chemotherapy)
Patients that experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy receive rifaximin PO BID on days 1-5 and standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\>
* Best Practice: Given standard of care pertuzumab-based chemotherapy \>
* Questionnaire Administration: Ancillary studies \>
* Rifaximin: Given PO
|
Arm II (Pertuzumab-based Chemotherapy)
Patients that do not experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy continue receiving standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\>
* Best Practice: Given standard of care pertuzumab-based chemotherapy \>
* Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
2
|
|
Overall Study
COMPLETED
|
15
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Arm I (Rifaximin, Pertuzumab-based Chemotherapy)
Patients that experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy receive rifaximin PO BID on days 1-5 and standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\>
* Best Practice: Given standard of care pertuzumab-based chemotherapy \>
* Questionnaire Administration: Ancillary studies \>
* Rifaximin: Given PO
|
Arm II (Pertuzumab-based Chemotherapy)
Patients that do not experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy continue receiving standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\>
* Best Practice: Given standard of care pertuzumab-based chemotherapy \>
* Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Alternative therapy
|
1
|
0
|
|
Overall Study
Discontinuation of pertuzumab
|
1
|
0
|
Baseline Characteristics
Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients With Stage I-III HER2 Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Rifaximin, Pertuzumab-based Chemotherapy)
n=18 Participants
Patients that experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy receive rifaximin PO BID on days 1-5 and standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\>
* Best Practice: Given standard of care pertuzumab-based chemotherapy \>
* Questionnaire Administration: Ancillary studies \>
* Rifaximin: Given PO
|
Arm II (Pertuzumab-based Chemotherapy)
n=2 Participants
Patients that do not experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy continue receiving standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\>
* Best Practice: Given standard of care pertuzumab-based chemotherapy\>
* Questionnaire Administration: Ancillary studies
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 9.72 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 7.07 • n=7 Participants
|
53.9 years
STANDARD_DEVIATION 9.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
20 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
18 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
2 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
ECOG Performance Status
0
|
16 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion (approximately 2 years, 3 months)Population: Only patients that received rifaximin were included in analysis
Based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner (1987).
Outcome measures
| Measure |
Arm I (Rifaximin, Pertuzumab-based Chemotherapy)
n=18 Participants
Patients that experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy receive rifaximin PO BID on days 1-5 and standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\>
* Best Practice: Given standard of care pertuzumab-based chemotherapy \>
* Questionnaire Administration: Ancillary studies \>
* Rifaximin: Given PO
|
Arm II (Pertuzumab-based Chemotherapy)
Patients that do not experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy continue receiving standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\>
* Best Practice: Given standard of care pertuzumab-based chemotherapy\>
* Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Reduction Rate of >= Grade 2 Abdominal Toxicities Including Abdominal Distension, Abdominal Pain, Diarrhea, Dyspepsia, Stomach Pain, and Typhlitis
|
0.833 proportion of participants
Interval 0.5858 to 0.9642
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsNumber of patients that experienced a dose reductions with pertuzumab due to gastrointestinal side effects.
Outcome measures
| Measure |
Arm I (Rifaximin, Pertuzumab-based Chemotherapy)
n=18 Participants
Patients that experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy receive rifaximin PO BID on days 1-5 and standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\>
* Best Practice: Given standard of care pertuzumab-based chemotherapy \>
* Questionnaire Administration: Ancillary studies \>
* Rifaximin: Given PO
|
Arm II (Pertuzumab-based Chemotherapy)
n=2 Participants
Patients that do not experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy continue receiving standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\>
* Best Practice: Given standard of care pertuzumab-based chemotherapy\>
* Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Dose Reductions of Treatment With Pertuzumab
|
10 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsNumber of patients that experienced a dose delay with pertuzumab due to gastrointestinal side effects.
Outcome measures
| Measure |
Arm I (Rifaximin, Pertuzumab-based Chemotherapy)
n=18 Participants
Patients that experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy receive rifaximin PO BID on days 1-5 and standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\>
* Best Practice: Given standard of care pertuzumab-based chemotherapy \>
* Questionnaire Administration: Ancillary studies \>
* Rifaximin: Given PO
|
Arm II (Pertuzumab-based Chemotherapy)
n=2 Participants
Patients that do not experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy continue receiving standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\>
* Best Practice: Given standard of care pertuzumab-based chemotherapy\>
* Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Dose Delays of Treatment With Pertuzumab
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsThe number of patients that experienced discontinuation of treatment with pertuzumab due to gastrointestinal side effects.
Outcome measures
| Measure |
Arm I (Rifaximin, Pertuzumab-based Chemotherapy)
n=18 Participants
Patients that experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy receive rifaximin PO BID on days 1-5 and standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\>
* Best Practice: Given standard of care pertuzumab-based chemotherapy \>
* Questionnaire Administration: Ancillary studies \>
* Rifaximin: Given PO
|
Arm II (Pertuzumab-based Chemotherapy)
n=2 Participants
Patients that do not experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy continue receiving standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\>
* Best Practice: Given standard of care pertuzumab-based chemotherapy\>
* Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Discontinuation of Treatment With Pertuzumab
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsNumber of patients that experienced a reduction of mean number of stools recorded while on treatment compared to baseline will be reported
Outcome measures
| Measure |
Arm I (Rifaximin, Pertuzumab-based Chemotherapy)
n=18 Participants
Patients that experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy receive rifaximin PO BID on days 1-5 and standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\>
* Best Practice: Given standard of care pertuzumab-based chemotherapy \>
* Questionnaire Administration: Ancillary studies \>
* Rifaximin: Given PO
|
Arm II (Pertuzumab-based Chemotherapy)
n=2 Participants
Patients that do not experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy continue receiving standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\>
* Best Practice: Given standard of care pertuzumab-based chemotherapy\>
* Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Number of Patient With a Reduction of Mean Number of Stools
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (at enrollment); following each treatment cycle (21 days +/- 7 days), up to 5 cyclesPopulation: Only patients in arm 1 were included in analysis. Patients in arm 2 did not experience PIGT. Only patients still on treatment were included in each cycle's analysis.
Maximum PIGT score represents the maximum grade of adverse event experienced by a patient out of all gastrointestinal adverse events. PIGT scores are assessed according to NCI CTCAE v5.0, with a minimum grade of 0 (no event) and maximum grade of 5 (death).
Outcome measures
| Measure |
Arm I (Rifaximin, Pertuzumab-based Chemotherapy)
n=18 Participants
Patients that experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy receive rifaximin PO BID on days 1-5 and standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\>
* Best Practice: Given standard of care pertuzumab-based chemotherapy \>
* Questionnaire Administration: Ancillary studies \>
* Rifaximin: Given PO
|
Arm II (Pertuzumab-based Chemotherapy)
Patients that do not experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy continue receiving standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.\>
* Best Practice: Given standard of care pertuzumab-based chemotherapy\>
* Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Average Maximum Pertuzumab Induced Gastrointestinal Toxicities (PIGT) Score
Cycle 3
|
1.71 units on a scale
Standard Deviation 0.85
|
—
|
|
Average Maximum Pertuzumab Induced Gastrointestinal Toxicities (PIGT) Score
Cycle 4
|
1.5 units on a scale
Standard Deviation 0.73
|
—
|
|
Average Maximum Pertuzumab Induced Gastrointestinal Toxicities (PIGT) Score
Cycle 5
|
1.53 units on a scale
Standard Deviation 0.74
|
—
|
|
Average Maximum Pertuzumab Induced Gastrointestinal Toxicities (PIGT) Score
Baseline
|
2.17 units on a scale
Standard Deviation 0.38
|
—
|
|
Average Maximum Pertuzumab Induced Gastrointestinal Toxicities (PIGT) Score
Cycle 1
|
1.61 units on a scale
Standard Deviation 0.78
|
—
|
|
Average Maximum Pertuzumab Induced Gastrointestinal Toxicities (PIGT) Score
Cycle 2
|
1.83 units on a scale
Standard Deviation 0.79
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 3 yearsDescriptive statistics (mean, standard deviation \[sd\], median, interquartile range \[iqr\]) and longitudinal plots (raw value, change, change in percentage) will be used to summarize the baseline levels of hydrogen/methane peak by hydrogen breath test , diversity of gut microbiome(number of species) and specific species by fecal microbiome, and levels of urine mannitol and lactulose by permeability test before and after rifaximin.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 3 yearsDescriptive statistics (mean, sd, median, iqr) and longitudinal plots (raw value, change, change in percentage) will be used to summarize the baseline levels of hydrogen/methane peak by hydrogen breath test, diversity of gut microbiome (number of species) and specific species by fecal microbiome, and levels of urine mannitol and lactulose by permeability test before and after pertuzumab-based chemotherapy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsDescriptive statistics (mean, sd, median, iqr) and longitudinal plots (raw value, change, change in percentage) will be used to the fecal microbiome, hydrogen breath test, and permeability test among patients with or without PIGT. The study is not powered to detect any differences between the two arms; the main purpose is to quantify and evaluate differences descriptively between patients who develop and do not develop PIGT (between arm 1 and arm 2) to inform subsequent research.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Rifaximin, Pertuzumab-based Chemotherapy)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Arm II (Pertuzumab-based Chemotherapy)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Rifaximin, Pertuzumab-based Chemotherapy)
n=18 participants at risk
Patients that experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy receive rifaximin PO BID on days 1-5 and standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. \>
* Best Practice: Given standard of care pertuzumab-based chemotherapy \>
* Questionnaire Administration: Ancillary studies \>
* Rifaximin: Given PO
|
Arm II (Pertuzumab-based Chemotherapy)
n=2 participants at risk
Patients that do not experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy continue receiving standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. \> \> Best Practice: Given standard of care pertuzumab-based chemotherapy \>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Nervous system disorders
Intracranial hemorrhage
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
Nervous system disorders
Syncope
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
Other adverse events
| Measure |
Arm I (Rifaximin, Pertuzumab-based Chemotherapy)
n=18 participants at risk
Patients that experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy receive rifaximin PO BID on days 1-5 and standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. \>
* Best Practice: Given standard of care pertuzumab-based chemotherapy \>
* Questionnaire Administration: Ancillary studies \>
* Rifaximin: Given PO
|
Arm II (Pertuzumab-based Chemotherapy)
n=2 participants at risk
Patients that do not experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy continue receiving standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. \> \> Best Practice: Given standard of care pertuzumab-based chemotherapy \>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
88.9%
16/18 • Number of events 67 • 3 years
|
100.0%
2/2 • Number of events 6 • 3 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
22.2%
4/18 • Number of events 6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
11.1%
2/18 • Number of events 3 • 3 years
|
0.00%
0/2 • 3 years
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
Ear and labyrinth disorders
Tinnitus
|
22.2%
4/18 • Number of events 15 • 3 years
|
0.00%
0/2 • 3 years
|
|
Ear and labyrinth disorders
Vertigo
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
Eye disorders
Blurred vision
|
27.8%
5/18 • Number of events 14 • 3 years
|
0.00%
0/2 • 3 years
|
|
Eye disorders
Dry eye
|
33.3%
6/18 • Number of events 15 • 3 years
|
0.00%
0/2 • 3 years
|
|
Eye disorders
Eye disorders - Other, specify
|
11.1%
2/18 • Number of events 3 • 3 years
|
0.00%
0/2 • 3 years
|
|
Eye disorders
Watering eyes
|
0.00%
0/18 • 3 years
|
50.0%
1/2 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
6/18 • Number of events 20 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
94.4%
17/18 • Number of events 67 • 3 years
|
100.0%
2/2 • Number of events 6 • 3 years
|
|
Gastrointestinal disorders
Esophagitis
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
22.2%
4/18 • Number of events 11 • 3 years
|
50.0%
1/2 • Number of events 5 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
38.9%
7/18 • Number of events 12 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
11.1%
2/18 • Number of events 9 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
11.1%
2/18 • Number of events 2 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
77.8%
14/18 • Number of events 43 • 3 years
|
100.0%
2/2 • Number of events 6 • 3 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
11.1%
2/18 • Number of events 7 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
4/18 • Number of events 5 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Chills
|
5.6%
1/18 • Number of events 2 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Edema limbs
|
16.7%
3/18 • Number of events 3 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Fatigue
|
77.8%
14/18 • Number of events 55 • 3 years
|
100.0%
2/2 • Number of events 6 • 3 years
|
|
General disorders
Fever
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
38.9%
7/18 • Number of events 23 • 3 years
|
50.0%
1/2 • Number of events 3 • 3 years
|
|
General disorders
Pain
|
0.00%
0/18 • 3 years
|
50.0%
1/2 • Number of events 1 • 3 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
16.7%
3/18 • Number of events 4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Infections and infestations
Papulopustular rash
|
5.6%
1/18 • Number of events 4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Infections and infestations
Skin infection
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
Infections and infestations
Thrush
|
5.6%
1/18 • Number of events 3 • 3 years
|
0.00%
0/2 • 3 years
|
|
Infections and infestations
Upper respiratory infection
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
44.4%
8/18 • Number of events 25 • 3 years
|
100.0%
2/2 • Number of events 5 • 3 years
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
3/18 • Number of events 4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
22.2%
4/18 • Number of events 8 • 3 years
|
50.0%
1/2 • Number of events 2 • 3 years
|
|
Investigations
Blood bilirubin increased
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
11.1%
2/18 • Number of events 5 • 3 years
|
50.0%
1/2 • Number of events 4 • 3 years
|
|
Investigations
Creatinine increased
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Investigations - Other, specify
|
22.2%
4/18 • Number of events 11 • 3 years
|
100.0%
2/2 • Number of events 2 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
22.2%
4/18 • Number of events 7 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Neutrophil count decreased
|
11.1%
2/18 • Number of events 7 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Platelet count decreased
|
44.4%
8/18 • Number of events 18 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
White blood cell decreased
|
11.1%
2/18 • Number of events 6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
2/18 • Number of events 5 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
11.1%
2/18 • Number of events 4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
5.6%
1/18 • Number of events 3 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
3/18 • Number of events 7 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
61.1%
11/18 • Number of events 25 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
44.4%
8/18 • Number of events 22 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
2/18 • Number of events 3 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.1%
2/18 • Number of events 3 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
11.1%
2/18 • Number of events 3 • 3 years
|
0.00%
0/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
3/18 • Number of events 6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Number of events 3 • 3 years
|
0.00%
0/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
38.9%
7/18 • Number of events 17 • 3 years
|
0.00%
0/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.2%
4/18 • Number of events 10 • 3 years
|
50.0%
1/2 • Number of events 2 • 3 years
|
|
Nervous system disorders
Dizziness
|
72.2%
13/18 • Number of events 32 • 3 years
|
50.0%
1/2 • Number of events 4 • 3 years
|
|
Nervous system disorders
Dysgeusia
|
44.4%
8/18 • Number of events 32 • 3 years
|
0.00%
0/2 • 3 years
|
|
Nervous system disorders
Headache
|
50.0%
9/18 • Number of events 23 • 3 years
|
100.0%
2/2 • Number of events 4 • 3 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
27.8%
5/18 • Number of events 11 • 3 years
|
50.0%
1/2 • Number of events 1 • 3 years
|
|
Nervous system disorders
Paresthesia
|
5.6%
1/18 • Number of events 3 • 3 years
|
50.0%
1/2 • Number of events 4 • 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
22.2%
4/18 • Number of events 15 • 3 years
|
50.0%
1/2 • Number of events 5 • 3 years
|
|
Nervous system disorders
Presyncope
|
5.6%
1/18 • Number of events 2 • 3 years
|
0.00%
0/2 • 3 years
|
|
Psychiatric disorders
Insomnia
|
11.1%
2/18 • Number of events 10 • 3 years
|
0.00%
0/2 • 3 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
Reproductive system and breast disorders
Dyspareunia
|
5.6%
1/18 • Number of events 2 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
11.1%
2/18 • Number of events 5 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.2%
4/18 • Number of events 7 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • Number of events 4 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
1/18 • Number of events 5 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
22.2%
4/18 • Number of events 9 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
11.1%
2/18 • Number of events 5 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
11.1%
2/18 • Number of events 3 • 3 years
|
0.00%
0/2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
66.7%
12/18 • Number of events 47 • 3 years
|
50.0%
1/2 • Number of events 5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
6/18 • Number of events 13 • 3 years
|
50.0%
1/2 • Number of events 3 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
16.7%
3/18 • Number of events 10 • 3 years
|
50.0%
1/2 • Number of events 5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
6/18 • Number of events 16 • 3 years
|
0.00%
0/2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
22.2%
4/18 • Number of events 6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
5.6%
1/18 • Number of events 2 • 3 years
|
0.00%
0/2 • 3 years
|
|
Vascular disorders
Flushing
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
|
Vascular disorders
Hot flashes
|
5.6%
1/18 • Number of events 3 • 3 years
|
0.00%
0/2 • 3 years
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Number of events 1 • 3 years
|
0.00%
0/2 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place