B-TREUH: Study of Euthyroid Hypothyroxinemia in Metastatic Breast Carcinoma
Study Details
Study Description
Brief Summary
Up to one third of breast cancer patients have hypothyroidism or hyperthyroidism. L-thyroxine (T4), or Synthroid, is the most commonly prescribed agent for the management of hypothyroidism in the US. However, there are data suggesting that triiodothyronine (T3) may have benefits in preventing disease progression over l-thyroxine (T4).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
It is estimated that there are approximately 155,000 living with metastatic breast cancer in the US and the number is estimated to increase over the next years (SEER data). Although their median survival has improved over the last 2 decades from 17 months to approximately 24 months attributed to newer treatments, there is an ongoing need for additional strategies and research to improve survival and quality of life.
Many studies have explored the connection between hypothyroidism and hyperthyroidism and breast cancer with varied results ranging up to one third prevalence. Low Triiodothyronine (T3) and elevated Thyroid-Stimulating Hormone (TSH) levels have been detected in newly diagnosed breast cancer patients. Other studies have suggested that some of the common symptoms reported by breast cancer survivors such as fatigue and depression can be attributed to subclinical hypothyroidism.
L-thyroxine (T4) is the most commonly prescribed agent for the management of hypothyroidism in the US. However, there are data suggesting that T4 is a potent pro-oncogenic agent. Proposed mechanisms include stimulation of mitogenesis, angiogenesis and resistance to apoptosis, opposition of anti-PDL-1 and radiation effects. It has been postulated that the avbeta3integrin that is universally expressed on cancer cells harbors a thyroid hormone receptor and T4 interacts with it.
Triiodothyronine (T3) on the other hand, is significantly less oncogenic and less mitogenic and is downstream of T4 which is a T3 pro-hormone. Therefore, exogenous supplementation of T3 would decrease the T4 levels creating the desired state of euthyroid hypothyroxinemia.
The rationale of this study is to replace L-thyroxine (T4) with Triiodothyronine (T3) in hypothyroid patients with metastatic breast carcinoma while they continue to receive standard systemic therapy, titrating the dose to achieve a state of euthyroid hypothyroxinemia which is turn would result in a lower risk of disease progression and improved survival by lowering the concentration of T4.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Triiodothyronine (T3) Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 < 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). |
Drug: Triiodothyronine (T3)
Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Progression-free Survival at 12 Months Based Upon Clinical and Radiological Assessments Completed as Part of Routine Care [12 months]
To prospectively evaluate the progression-free survival in hypothyroid patients with metastatic breast carcinoma who are rendered euthyroid and hypothyroxinemic. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the nadir sum of the longest diameter (SLD) of target lesions, or unequivocal progression (overall level of substantial worsening) in existing non-target lesions, or the appearance of one or more new lesions.
Secondary Outcome Measures
- Number of Patients With Both Metastatic Breast Cancer and Hypothyroidism in All Screened Patients. [Study duration, planned was 48 months but actual was 36 months [March 1, 2019 to March 9, 2022] due to premature closure due to planned relocation of the PI.]
To quantitate the prevalence of hypothyroidism in metastatic breast cancer patients at a community oncology practice.
- Measurement of Quality of Life Total Score Across Time Using Validated FACT-B Questionnaire [Baseline, 3, 6, 9, and 12 months]
Functional Assessment of Cancer Therapy - Breast (FACT-B) Total Score comprised of Physical Well Being (PWB), Social Well Being (SWB), Emotional Well Being (EWB), Functional Well Being (FWB), and Breast Cancer Subscale (BCS). Range is 0-148. A higher score indicates higher quality of life. Missing scores were handled by prorating values.
- Measurement of Energy Level Across Time Using FACT-B Question. [Baseline, 3, 6, 9, 12 months]
Functional Assessment of Cancer Therapy - Breast (FACT-B) Lack of energy on 5 point Likert scale as measured on FACT-B Physical Well-being subscale. Score of 0 indicates no lack of energy with score of 4 indicating total lack of energy.
- Time to Achieve Euthyroid Hypothyroxinemia State [Number of days between initiation of triiodothyronine (T3) and documentation of first normal TSH value for each participant, assessed up to 12 months]
To study the average time required to achieve euthyroid hypothyroxinemia state in qualifying patients. Thyroid function laboratory testing was performed at baseline and then at every 4 weekly intervals until 12 weeks then every 3 monthly thereafter, unless thyroid-stimulating hormone (TSH) was abnormal. If a normal TSH level was not achieved by the 12 week visit, repeat TSH measurements were ordered every 4-6 weeks until the TSH value was within the laboratory normal reference range. Initial euthyroid state defined by number of days between initiation of triiodothyronine (T3) and documentation of first normal TSH value.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age greater than or equal to 18
-
Male or female with diagnosis of metastatic breast carcinoma and documented history of hypothyroidism .
-
TSH level within normal range at baseline
-
Life expectancy estimated > 3 months
-
Ability and willingness to provide informed consent
Exclusion Criteria:
-
Life expectancy estimated to be less than 3 months
-
Is currently pregnant or intends to become pregnant during the duration of the study
-
Active angina, New York Heart Association (NYHA) advanced [Class III/IV] congestive heart failure, or uncontrolled cardiac arrhythmia within 6 months of enrollment
-
History of thyrotoxicosis
-
History of adrenal insufficiency
-
Hypersensitivity to any active or extraneous constituents in Triiodothyronine (T3)/liothyronine sodium
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aultman Medical Group Hematology and Oncology | Canton | Ohio | United States | 44710 |
Sponsors and Collaborators
- Aultman Health Foundation
Investigators
- Principal Investigator: Shruti Trehan, MD, Aultman Health Foundation
Study Documents (Full-Text)
More Information
Publications
None provided.- 2018.08.ST
Study Results
Participant Flow
| Recruitment Details | 7 participants from one local medical oncology practice were enrolled between March 1, 2019 and March 9, 2022. |
|---|---|
| Pre-assignment Detail | All enrolled participants underwent a four day washout period of L-thyroxine (T4) prior to Triiodothyronine (T3) initiation. There were no enrolled participants who were excluded from the study. |
| Arm/Group Title | Triiodothyronine (T3) |
|---|---|
| Arm/Group Description | Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 < 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated. |
| Period Title: Overall Study | |
| STARTED | 7 |
| COMPLETED | 5 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Triiodothyronine (T3) |
|---|---|
| Arm/Group Description | Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 < 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated. |
| Overall Participants | 7 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
63.7
(13.52)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
7
100%
|
| Male |
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
7
100%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
1
14.3%
|
| White |
6
85.7%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
7
100%
|
| Duration of time since diagnosis of metastatic disease (months) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [months] |
62.1
(79.52)
|
Outcome Measures
| Title | Number of Participants With Progression-free Survival at 12 Months Based Upon Clinical and Radiological Assessments Completed as Part of Routine Care |
|---|---|
| Description | To prospectively evaluate the progression-free survival in hypothyroid patients with metastatic breast carcinoma who are rendered euthyroid and hypothyroxinemic. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the nadir sum of the longest diameter (SLD) of target lesions, or unequivocal progression (overall level of substantial worsening) in existing non-target lesions, or the appearance of one or more new lesions. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Last enrolled subject was only able to be followed for 9 months due to early termination of study. Subject not included in primary outcome measure. |
| Arm/Group Title | Triiodothyronine (T3) |
|---|---|
| Arm/Group Description | Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 < 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated. |
| Measure Participants | 6 |
| Count of Participants [Participants] |
4
57.1%
|
| Title | Number of Patients With Both Metastatic Breast Cancer and Hypothyroidism in All Screened Patients. |
|---|---|
| Description | To quantitate the prevalence of hypothyroidism in metastatic breast cancer patients at a community oncology practice. |
| Time Frame | Study duration, planned was 48 months but actual was 36 months [March 1, 2019 to March 9, 2022] due to premature closure due to planned relocation of the PI. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Outcome was number of practice patients with both metastatic breast cancer and hypothyroidism. Of the 26 identified, 7 patients consented to enroll on the study. |
| Arm/Group Title | Triiodothyronine (T3) |
|---|---|
| Arm/Group Description | Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 < 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated. |
| Measure Participants | 126 |
| Count of Participants [Participants] |
26
371.4%
|
| Title | Measurement of Quality of Life Total Score Across Time Using Validated FACT-B Questionnaire |
|---|---|
| Description | Functional Assessment of Cancer Therapy - Breast (FACT-B) Total Score comprised of Physical Well Being (PWB), Social Well Being (SWB), Emotional Well Being (EWB), Functional Well Being (FWB), and Breast Cancer Subscale (BCS). Range is 0-148. A higher score indicates higher quality of life. Missing scores were handled by prorating values. |
| Time Frame | Baseline, 3, 6, 9, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of the 7 subjects enrolled only 5 of the patients completed Quality of Life FACT-B questionnaires for all five timepoint. Two subjects did not complete the 12 months surveys due to death or premature study termination. |
| Arm/Group Title | Triiodothyronine (T3) |
|---|---|
| Arm/Group Description | Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 < 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated. |
| Measure Participants | 7 |
| Baseline |
114
(24.56)
|
| At 3 months |
114
(16.80)
|
| At 6 months |
116
(20.71)
|
| At 9 months |
112
(26.92)
|
| At 12 months |
110
(23.68)
|
| Title | Measurement of Energy Level Across Time Using FACT-B Question. |
|---|---|
| Description | Functional Assessment of Cancer Therapy - Breast (FACT-B) Lack of energy on 5 point Likert scale as measured on FACT-B Physical Well-being subscale. Score of 0 indicates no lack of energy with score of 4 indicating total lack of energy. |
| Time Frame | Baseline, 3, 6, 9, 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of the 7 subjects enrolled only 5 of the patients completed Quality of Life FACT-B questionnaires for all five timepoint. Two subjects did not complete the 12 months surveys due to death or premature study termination. |
| Arm/Group Title | Triiodothyronine (T3) |
|---|---|
| Arm/Group Description | Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 < 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated. |
| Measure Participants | 7 |
| Baseline |
2.9
(1.07)
|
| 3 months |
2.4
(1.3)
|
| 6 months |
3.0
(1.16)
|
| 9 months |
3.0
(1.53)
|
| 12 months |
2.6
(1.14)
|
| Title | Time to Achieve Euthyroid Hypothyroxinemia State |
|---|---|
| Description | To study the average time required to achieve euthyroid hypothyroxinemia state in qualifying patients. Thyroid function laboratory testing was performed at baseline and then at every 4 weekly intervals until 12 weeks then every 3 monthly thereafter, unless thyroid-stimulating hormone (TSH) was abnormal. If a normal TSH level was not achieved by the 12 week visit, repeat TSH measurements were ordered every 4-6 weeks until the TSH value was within the laboratory normal reference range. Initial euthyroid state defined by number of days between initiation of triiodothyronine (T3) and documentation of first normal TSH value. |
| Time Frame | Number of days between initiation of triiodothyronine (T3) and documentation of first normal TSH value for each participant, assessed up to 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Triiodothyronine (T3) |
|---|---|
| Arm/Group Description | Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 < 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated. |
| Measure Participants | 7 |
| Mean (Standard Deviation) [days] |
59.6
(50.64)
|
Adverse Events
| Time Frame | Adverse event data was collected for each subject at every 3 monthly visit and is reported as below. Attribution or etiology under comments below. Study period was 12 months (9 months for last patient due to premature termination of study) | |
|---|---|---|
| Adverse Event Reporting Description | 112/124 - 88.7% of adverse events were deemed to be related to underlying metastatic breast cancer and/or treatment thereof. 0 events reported definitely related to the study drug 14/124 -11.3% events reported as possible or probably related to the study drug Cause of mortality reported due to metastatic breast cancer. | |
| Arm/Group Title | Triiodothyronine (T3) | |
| Arm/Group Description | Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 < 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3). Triiodothyronine (T3): Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated. | |
All Cause Mortality |
||
| Triiodothyronine (T3) | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/7 (14.3%) | |
Serious Adverse Events |
||
| Triiodothyronine (T3) | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/7 (28.6%) | |
| Gastrointestinal disorders | ||
| ascites | 1/7 (14.3%) | 1 |
| Infections and infestations | ||
| Cellulitis | 1/7 (14.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Pleural effusion | 1/7 (14.3%) | 2 |
Other (Not Including Serious) Adverse Events |
||
| Triiodothyronine (T3) | ||
| Affected / at Risk (%) | # Events | |
| Total | 7/7 (100%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 2/7 (28.6%) | 2 |
| Cardiac disorders | ||
| Sinus tachycardia | 1/7 (14.3%) | 1 |
| Palpitations | 1/7 (14.3%) | 1 |
| Endocrine disorders | ||
| Endocrine disorder: Cold intolerance | 1/7 (14.3%) | 1 |
| Eye disorders | ||
| Watering eyes | 1/7 (14.3%) | 1 |
| Gastrointestinal disorders | ||
| Dyspepsia | 2/7 (28.6%) | 2 |
| Diarrhea | 2/7 (28.6%) | 2 |
| Abdominal pain | 2/7 (28.6%) | 2 |
| Bloating | 1/7 (14.3%) | 1 |
| Gastrointestinal disorder: Other hemoccult positive | 1/7 (14.3%) | 1 |
| Gastrointestinal disorders: Other - Gastroenteritis | 1/7 (14.3%) | 1 |
| Nausea | 1/7 (14.3%) | 1 |
| Mucositis Oral | 1/7 (14.3%) | 1 |
| Tooth loss | 1/7 (14.3%) | 1 |
| General disorders | ||
| Edema limbs | 1/7 (14.3%) | 1 |
| Fatigue | 4/7 (57.1%) | 4 |
| Chills | 2/7 (28.6%) | 2 |
| Fever | 2/7 (28.6%) | 2 |
| Non-cardiac chest pain | 1/7 (14.3%) | 1 |
| Malaise | 1/7 (14.3%) | 1 |
| Pain | 2/7 (28.6%) | 2 |
| Infections and infestations | ||
| Bronchial infection | 1/7 (14.3%) | 1 |
| Injury, poisoning and procedural complications | ||
| Bruising | 1/7 (14.3%) | 1 |
| Investigations | ||
| Weight loss | 2/7 (28.6%) | 2 |
| Neutrophil count decreased | 3/7 (42.9%) | 4 |
| White blood cell count decreased | 3/7 (42.9%) | 4 |
| Alanine aminotransferase increased | 1/7 (14.3%) | 1 |
| Aspartate aminotransferase increased | 1/7 (14.3%) | 1 |
| Platelet count decreased | 2/7 (28.6%) | 2 |
| Blood bilirubin increased | 1/7 (14.3%) | 1 |
| Alkaline phosphatase increased | 2/7 (28.6%) | 2 |
| Lymphocyte count decrease | 3/7 (42.9%) | 5 |
| Metabolism and nutrition disorders | ||
| Anorexia | 1/7 (14.3%) | 1 |
| Hypoalbuminemia | 2/7 (28.6%) | 4 |
| Hyperglycemia | 4/7 (57.1%) | 7 |
| Hypoglycemia | 1/7 (14.3%) | 1 |
| Hyperkalemia | 1/7 (14.3%) | 1 |
| Hypercalcemia | 1/7 (14.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Generalized muscle weakness | 2/7 (28.6%) | 2 |
| Pain in extremity | 2/7 (28.6%) | 2 |
| Arthalgia | 2/7 (28.6%) | 2 |
| Nervous system disorders | ||
| Memory Impairment | 3/7 (42.9%) | 3 |
| Dizziness | 3/7 (42.9%) | 3 |
| Headache | 2/7 (28.6%) | 4 |
| Dysgeusia | 1/7 (14.3%) | 1 |
| Anosmia | 1/7 (14.3%) | 1 |
| Psychiatric disorders | ||
| Insomnia | 1/7 (14.3%) | 1 |
| Anxiety | 1/7 (14.3%) | 1 |
| Depression | 1/7 (14.3%) | 1 |
| Renal and urinary disorders | ||
| Urinary incontinence | 1/7 (14.3%) | 1 |
| Blood urea nitrogen increase | 1/7 (14.3%) | 2 |
| Creatinine increase | 1/7 (14.3%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||
| Epistaxis | 3/7 (42.9%) | 3 |
| Dyspnea | 3/7 (42.9%) | 4 |
| Cough | 1/7 (14.3%) | 1 |
| Nasal congestion | 1/7 (14.3%) | 1 |
| Rhinorrhea | 1/7 (14.3%) | 1 |
| Alopecia | 1/7 (14.3%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Nail changes | 2/7 (28.6%) | 2 |
| Skin disorder other: Contact dermatitis | 1/7 (14.3%) | 1 |
| Skin disorder: Other - Chest wall redness | 1/7 (14.3%) | 1 |
| Pruritis | 1/7 (14.3%) | 1 |
| Palmar-plantar erythrodysesthesia syndrome | 1/7 (14.3%) | 1 |
| Skin disorder: Other-onycholysis | 2/7 (28.6%) | 2 |
| Nail peeling | 1/7 (14.3%) | 1 |
| Vascular disorders | ||
| Hypertension | 5/7 (71.4%) | 7 |
| Hypotension | 1/7 (14.3%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Shruti Trehan MD |
|---|---|
| Organization | Aultman Hospital |
| Phone | 3303634162 |
| trehanshruti4@gmail.com |
- 2018.08.ST