Daratumumab for the Treatment of Patients With AL Amyloidosis
Study Details
Study Description
Brief Summary
Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month. Study treatment may continue until disease progression, unacceptable toxicity, or decision to withdraw from the trial. Disease evaluations will be performed every three months until disease progression.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1/Phase 2 |
Detailed Description
This Phase I/II study is intended to evaluate the safety and tolerability of infusion of daratumumab in AL amyloidosis, specifically with respect to infusion reactions. In addition, the investigators would like to assess organ response with respect to cardiac biomarkers and proteinuria, as well as hematologic response and time to next treatment. Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month. Study treatment may continue until disease progression, unacceptable toxicity, or decision to withdraw from the trial. Disease evaluations will be performed every three months until disease progression.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Daratumumab Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month. |
Drug: daratumumab
Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression or inability to tolerate.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Assess the Number of Patients Who Respond to Treatment [3 months]
Number of participants with response and ability to tolerate study treatment in each of these categories: Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). All participants were able to tolerate study treatment. Per protocol, overall response designations are a combination of hematologic response. A CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio; a VGPR is reduction in the dFLC* to <40 mg/L, a PR is dFLC reduction by >50%; SD is not meeting criteria for CR, VGPR, PR, or PD; and PD is an increase in FLC of 50% to >100 mg/L. * "dFLC" is difference in involved and uninvolved serum Free Light-Chain levels.
Secondary Outcome Measures
- Time to Next Treatment [Up to 3 years]
Number of months from study drug initiation to starting another treatment
- Assess Hematologic Response Based on Blood and Urine Testing Using Standard Criteria [3 months]
Number of patients with hematologic complete response (CR), very good partial response (VGPR), or partial response (PR). Per protocol, a hematologic CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio; a VGPR is reduction in the dFLC* to <40 mg/L; and a PR is dFLC reduction by >50%. * "dFLC" is difference in involved and uninvolved serum free light-chain levels
- Assess Organ Responses Based on Standard Criteria Included in Protocol [3 months]
Number of patients with organ response based on standard criteria included in protocol. Cardiac response is defined as: NT-proBNP response (>30% and >300 ng/L decrease in patients with a baseline NT-proBNP >650 ng/L; and/or NYHA class response (> two-class decrease if baseline NYHA class 3 or 4) Renal response is defined as: Decrease in proteinuria by > 30% or below 0.5 g/24 h without renal progression. Serum creatinine and creatinine clearance must not worsen by 25% over baseline
Eligibility Criteria
Criteria
Inclusion Criteria:
- Histological diagnosis of primary systemic (AL) amyloidosis:
-
At least one tissue demonstrating positive Congo Red staining with characteristic apple green birefringence AND
-
Evidence of a clonal plasma cell dyscrasia:
-
Monoclonal protein in the serum and/or urine by immunofixation electrophoresis AND/OR ii. Abnormal serum free light chain assay AND/OR iii. Clonal plasma cell population in the bone marrow demonstrated by immunohistochemistry, flow cytometry or in situ hybridization AND
-
Evidence of organ involvement other than carpal tunnel syndrome. Confirmation of tissue diagnosis at all sites of organ dysfunction is encouraged, but not required.
-
Must have relapsed after or been refractory to at least one prior treatment regimen of proven efficacy in the treatment of AL amyloidosis
-
Must be > 18 years of age.
-
Must have a performance status of 0-2 by Eastern Cooperative Oncology Group (ECOG) criteria
-
Must have adequate hepatic function as evidenced by serum bilirubin values < 2.0 mg/dL; alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) < 3x upper limit of normal (ULN).
-
Must have an absolute neutrophil count ≥1000/mm3, hemoglobin ≥7.5 g/dL, and platelet count ≥50×109/L
Exclusion Criteria:
-
• Renal Insufficiency (CrCL <20mL/min), calculated by Cockcroft-Gault Equation Creatinine Clearance = Sex * ((140 - Age) / (SerumCreat)) * (Weight / 72) Equation parameters such as sex have two or more discrete values that may be used in the calculation. The numbers in the parentheses, e.g. (1), represent the values that will be used. The default unit of measure for weight is kilograms. Please verify that the correct unit of measure has been selected.
-
Mayo clinic cardiac biomarker stage IIIb
-
Evidence of significant cardiovascular conditions as specified below:
-
B-type Natriuretic Peptide; N-terminal pro b-type Natriuretic Peptide (NT-ProBNP) > 8500 ng/L (Mayo Stage IIIb patients are excluded)
-
New York Heart Association (NYHA) classification IIIB or IV heart failure
-
Unstable Angina, Arrhythmia, prolonged corrected QT (QTc) interval, symptomatic orthostatic hypotension, or supine systolic blood pressure < 90 mm Hg.
-
left ventricular ejection fraction (LVEF) <40%
-
Overt multiple myeloma (>30% bone marrow plasmacytosis, extensive (>2) lytic lesions, or hypercalcemia).
-
Plan for autologous stem cell transplant in the six months prior to study drug (stem cell collection is permitted during the first six months of study treatment)
-
Any form of secondary or familial (ATTR) amyloidosis
-
The presence or history of another malignancy is not allowed except for the following:
-
adequately treated basal cell or squamous cell skin cancer,
-
in situ cervical cancer,
-
adequately treated Stage I or II cancer from which the patient is currently in complete remission, any other cancer from which the patient has been disease-free for 5 years.
-
Known to be Human Immunodeficiency Virus (HIV) positivity.
-
Pregnant or nursing women. Women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
-
Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume at one second (FEV1) <50% of predicted normal. Note that forced expiratory volume at one second FEV1 testing is required for patients suspected of having COPD.
-
Known moderate or severe persistent asthma within the past 2 years or currently has uncontrolled asthma of any classification
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
Sponsors and Collaborators
- Boston Medical Center
- Janssen Pharmaceuticals
Investigators
- Principal Investigator: Vaishali Sanchorawala, MD, Boston Medical Center
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- H-35360
- 54767414AMY2002
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Daratumumab |
---|---|
Arm/Group Description | Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed. |
Period Title: Overall Study | |
STARTED | 22 |
COMPLETED | 22 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | Daratumumab |
---|---|
Arm/Group Description | Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed. |
Overall Participants | 22 |
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
63
|
Sex: Female, Male (Count of Participants) | |
Female |
6
27.3%
|
Male |
16
72.7%
|
Race/Ethnicity, Customized (Count of Participants) | |
White Non-Hispanic |
16
72.7%
|
Black or African American |
7
31.8%
|
Asian |
0
0%
|
Hispanic or Latino |
2
9.1%
|
Other |
0
0%
|
Region of Enrollment (participants) [Number] | |
United States |
22
100%
|
Time since initial diagnosis (months) [Median (Full Range) ] | |
Median (Full Range) [months] |
48
|
Prior therapies (lines of treatment) [Median (Full Range) ] | |
Median (Full Range) [lines of treatment] |
2
|
Time since last plasma cell-directed treatment (months) [Median (Full Range) ] | |
Median (Full Range) [months] |
9
|
dFLC (mg/L) [Median (Full Range) ] | |
Median (Full Range) [mg/L] |
80.7
|
Number of organ systems involved (organ systems) [Median (Full Range) ] | |
Median (Full Range) [organ systems] |
2
|
NYHA Class II or III (Count of Participants) | |
Count of Participants [Participants] |
11
50%
|
Outcome Measures
Title | Assess the Number of Patients Who Respond to Treatment |
---|---|
Description | Number of participants with response and ability to tolerate study treatment in each of these categories: Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). All participants were able to tolerate study treatment. Per protocol, overall response designations are a combination of hematologic response. A CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio; a VGPR is reduction in the dFLC* to <40 mg/L, a PR is dFLC reduction by >50%; SD is not meeting criteria for CR, VGPR, PR, or PD; and PD is an increase in FLC of 50% to >100 mg/L. * "dFLC" is difference in involved and uninvolved serum Free Light-Chain levels. |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Daratumumab |
---|---|
Arm/Group Description | Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed. |
Measure Participants | 22 |
Complete Response (CR) |
5
22.7%
|
Very Good Partial Response (VGPR) |
13
59.1%
|
Partial Response (PR) |
2
9.1%
|
Stable Disease (SD) |
1
4.5%
|
Progressive Disease (PD) |
1
4.5%
|
Title | Time to Next Treatment |
---|---|
Description | Number of months from study drug initiation to starting another treatment |
Time Frame | Up to 3 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Daratumumab |
---|---|
Arm/Group Description | Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed. |
Measure Participants | 22 |
<12 months |
3
13.6%
|
>12 months |
1
4.5%
|
No further treatment |
18
81.8%
|
Title | Assess Hematologic Response Based on Blood and Urine Testing Using Standard Criteria |
---|---|
Description | Number of patients with hematologic complete response (CR), very good partial response (VGPR), or partial response (PR). Per protocol, a hematologic CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio; a VGPR is reduction in the dFLC* to <40 mg/L; and a PR is dFLC reduction by >50%. * "dFLC" is difference in involved and uninvolved serum free light-chain levels |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Daratumumab |
---|---|
Arm/Group Description | Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed. |
Measure Participants | 22 |
Complete Response, Very Good Partial Response, or Partial Response |
20
90.9%
|
Stable Disease or Progressive Disease |
2
9.1%
|
Title | Assess Organ Responses Based on Standard Criteria Included in Protocol |
---|---|
Description | Number of patients with organ response based on standard criteria included in protocol. Cardiac response is defined as: NT-proBNP response (>30% and >300 ng/L decrease in patients with a baseline NT-proBNP >650 ng/L; and/or NYHA class response (> two-class decrease if baseline NYHA class 3 or 4) Renal response is defined as: Decrease in proteinuria by > 30% or below 0.5 g/24 h without renal progression. Serum creatinine and creatinine clearance must not worsen by 25% over baseline |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
19 evaluable patients with cardiac and/or renal involvement. |
Arm/Group Title | Daratumumab |
---|---|
Arm/Group Description | Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed. |
Measure Participants | 19 |
Count of Participants [Participants] |
14
63.6%
|
Adverse Events
Time Frame | First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months. | |
---|---|---|
Adverse Event Reporting Description | Adverse events were assessed at every study treatment visit. | |
Arm/Group Title | Daratumumab | |
Arm/Group Description | Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed. | |
All Cause Mortality |
||
Daratumumab | ||
Affected / at Risk (%) | # Events | |
Total | 4/22 (18.2%) | |
Serious Adverse Events |
||
Daratumumab | ||
Affected / at Risk (%) | # Events | |
Total | 11/22 (50%) | |
Cardiac disorders | ||
Atrial fibrillation | 4/22 (18.2%) | 5 |
Heart failure | 3/22 (13.6%) | 5 |
Myocardial infarction (NSTEMI) | 1/22 (4.5%) | 1 |
Gastrointestinal disorders | ||
Colitis | 1/22 (4.5%) | 1 |
Diarrhea | 2/22 (9.1%) | 2 |
Gastrointestinal hemorrhage - melena | 1/22 (4.5%) | 1 |
Nausea | 1/22 (4.5%) | 1 |
Upper gastrointestinal bleeding | 1/22 (4.5%) | 1 |
General disorders | ||
Fever | 1/22 (4.5%) | 1 |
Infections and infestations | ||
Sepsis | 2/22 (9.1%) | 2 |
Upper respiratory infection | 2/22 (9.1%) | 2 |
Urinary tract infection | 1/22 (4.5%) | 1 |
Investigations | ||
CK increased | 1/22 (4.5%) | 1 |
CPK increased | 1/22 (4.5%) | 1 |
Nervous system disorders | ||
Syncope | 2/22 (9.1%) | 3 |
Renal and urinary disorders | ||
Acute kidney injury | 3/22 (13.6%) | 3 |
Hematuria | 1/22 (4.5%) | 1 |
Renal and urinary disorders - other, UTI sepsis | 1/22 (4.5%) | 1 |
Urine output decreased | 1/22 (4.5%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||
Dyspnea | 1/22 (4.5%) | 1 |
Lung infection | 3/22 (13.6%) | 3 |
Vascular disorders | ||
Thromboembolic event | 1/22 (4.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||
Daratumumab | ||
Affected / at Risk (%) | # Events | |
Total | 22/22 (100%) | |
Blood and lymphatic system disorders | ||
Lymph node pain | 1/22 (4.5%) | 1 |
Cardiac disorders | ||
Atrial fibrillation | 4/22 (18.2%) | 4 |
Chest pain - cardiac | 1/22 (4.5%) | 1 |
Heart failure | 3/22 (13.6%) | 6 |
Palpitations | 2/22 (9.1%) | 5 |
Ear and labyrinth disorders | ||
Ear pain | 3/22 (13.6%) | 3 |
Hearing loss | 2/22 (9.1%) | 2 |
Tinnitus | 3/22 (13.6%) | 3 |
Vertigo | 1/22 (4.5%) | 1 |
Endocrine disorders | ||
Endocrine disorder - other, specify: TSH elevated | 3/22 (13.6%) | 10 |
Hyperthyroidism | 3/22 (13.6%) | 3 |
Hypothyroidism | 1/22 (4.5%) | 2 |
Eye disorders | ||
Blurred vision | 3/22 (13.6%) | 3 |
Cataract | 1/22 (4.5%) | 1 |
Conjunctivitis | 2/22 (9.1%) | 2 |
Dry eye | 2/22 (9.1%) | 2 |
Eye disorders - other, specify: cloudiness | 1/22 (4.5%) | 2 |
Eye disorders - other, specify: obstructive tear duct | 1/22 (4.5%) | 1 |
Eye disorders - other, specify: redness | 1/22 (4.5%) | 1 |
Eye disorders - other, specify: scleral abrasian | 1/22 (4.5%) | 3 |
Eye disorders - other, specify: Scotoma | 1/22 (4.5%) | 10 |
Eye disorders - other, specify: subconjunctival hemorrhage | 7/22 (31.8%) | 10 |
Eye infection | 1/22 (4.5%) | 1 |
Floaters | 1/22 (4.5%) | 4 |
Watering eyes | 1/22 (4.5%) | 1 |
Gastrointestinal disorders | ||
Abdominal distention | 7/22 (31.8%) | 16 |
Abdominal pain | 8/22 (36.4%) | 10 |
Anal hemorrhage | 1/22 (4.5%) | 2 |
Bloating | 1/22 (4.5%) | 1 |
Constipation | 8/22 (36.4%) | 16 |
Dental caries | 1/22 (4.5%) | 1 |
Diarrhea | 19/22 (86.4%) | 68 |
Dry mouth | 1/22 (4.5%) | 1 |
Flatulence | 1/22 (4.5%) | 1 |
Gastroesophageal Reflux | 3/22 (13.6%) | 3 |
Gastrointestinal disorder - other, specify: inguinal hernia | 2/22 (9.1%) | 2 |
Gastrointestinal disorder - other, specify: black stool | 1/22 (4.5%) | 2 |
Gastrointestinal disorder - other, specify: broken tooth | 1/22 (4.5%) | 1 |
Gastrointestinal disorder - other, specify: H. pylori | 1/22 (4.5%) | 1 |
Gastrointestinal disorder - other, specify: Tooth extraction | 2/22 (9.1%) | 2 |
Gastrointestinal disorder - other, specify: ulcer - Left lateral tongue | 1/22 (4.5%) | 1 |
Gastrointestinal disorder - other, specify: viral gastroenteritis | 1/22 (4.5%) | 2 |
Nausea | 13/22 (59.1%) | 35 |
Oral pain | 3/22 (13.6%) | 3 |
Vomiting | 8/22 (36.4%) | 11 |
General disorders | ||
Chest pain | 1/22 (4.5%) | 5 |
Chest pain - cardiac | 1/22 (4.5%) | 1 |
Chest pain - non cardiac | 1/22 (4.5%) | 2 |
Chills | 4/22 (18.2%) | 4 |
Edema limbs | 10/22 (45.5%) | 12 |
Fatigue | 16/22 (72.7%) | 33 |
Fever | 7/22 (31.8%) | 10 |
Flu like symptoms | 2/22 (9.1%) | 3 |
Gait disturbance | 1/22 (4.5%) | 2 |
Localized Edema | 3/22 (13.6%) | 4 |
Immune system disorders | ||
Immune system disorders - other, specify: lymphadenopathy | 1/22 (4.5%) | 1 |
Infections and infestations | ||
Laryngitis | 1/22 (4.5%) | 1 |
Pharyngitis | 1/22 (4.5%) | 1 |
Rhinitis infective | 8/22 (36.4%) | 17 |
Sinusitis | 3/22 (13.6%) | 3 |
Tooth infection | 1/22 (4.5%) | 1 |
Upper respiratory infection | 11/22 (50%) | 21 |
Urinary tract infection | 1/22 (4.5%) | 1 |
Vaginal infection | 1/22 (4.5%) | 1 |
Injury, poisoning and procedural complications | ||
Bruising | 10/22 (45.5%) | 14 |
Fall | 2/22 (9.1%) | 6 |
Investigations | ||
Alanine aminotransferase increased (ALTT) | 1/22 (4.5%) | 1 |
Alkaline phosphatase increased | 10/22 (45.5%) | 24 |
Anemia | 15/22 (68.2%) | 42 |
Anorexia | 1/22 (4.5%) | 1 |
Aspartate aminotransferase increased (AST) | 8/22 (36.4%) | 18 |
Cardiac troponin I increased | 10/22 (45.5%) | 30 |
Cholesterol high | 13/22 (59.1%) | 32 |
CPK increased | 10/22 (45.5%) | 31 |
Creatinine Increased | 17/22 (77.3%) | 67 |
Cystitis non-infective | 1/22 (4.5%) | 1 |
Investigations - other, specify: Lactate dehydrogenase elevated | 2/22 (9.1%) | 3 |
Lymphocyte count decreased | 18/22 (81.8%) | 76 |
Neutrophil count decreased | 5/22 (22.7%) | 14 |
Platelet count decreased | 10/22 (45.5%) | 18 |
Serum amylase increased | 2/22 (9.1%) | 2 |
Weight gain | 2/22 (9.1%) | 2 |
Weight loss | 1/22 (4.5%) | 1 |
White blood cell decreased | 6/22 (27.3%) | 11 |
Metabolism and nutrition disorders | ||
Anorexia | 7/22 (31.8%) | 13 |
Dehydration | 2/22 (9.1%) | 3 |
Hypercalcemia | 5/22 (22.7%) | 11 |
Hyperglycemia | 4/22 (18.2%) | 11 |
Hyperkalemia | 6/22 (27.3%) | 6 |
Hypermagnesemia | 14/22 (63.6%) | 23 |
Hypertriglyceridemia | 16/22 (72.7%) | 61 |
Hyperuricemia | 13/22 (59.1%) | 26 |
Hypoalbuminemia | 11/22 (50%) | 27 |
Hypocalcemia | 3/22 (13.6%) | 7 |
Hypoglycemia | 5/22 (22.7%) | 8 |
Hypokalemia | 1/22 (4.5%) | 1 |
Hypomagnesemia | 1/22 (4.5%) | 1 |
Hyponatremia | 7/22 (31.8%) | 10 |
Hypophosphatemia | 8/22 (36.4%) | 29 |
Metabolic and nutrition disorders - other, specify: increased appetite | 2/22 (9.1%) | 2 |
Metabolic and nutrition disorders - other, specify: iron deficiency | 8/22 (36.4%) | 9 |
Metabolic and nutrition disorders - other, specify: Type 2 diabetes mellitus | 2/22 (9.1%) | 2 |
Metabolic and nutrition disorders - other, specify: vitamin B12 deficiency | 1/22 (4.5%) | 3 |
Musculoskeletal and connective tissue disorders | ||
Arthalgia | 7/22 (31.8%) | 12 |
Arthritis | 1/22 (4.5%) | 1 |
Back pain | 12/22 (54.5%) | 28 |
Fever | 1/22 (4.5%) | 1 |
Flank pain | 3/22 (13.6%) | 3 |
Generalized muscle weakness | 1/22 (4.5%) | 1 |
Muscle weakness lower limb | 1/22 (4.5%) | 2 |
Musculoskeletal and connective tissue disorder - other, specify: Dupuytren's contracture | 1/22 (4.5%) | 1 |
Musculoskeletal and connective tissue disorder - other, specify: Restless legs | 4/22 (18.2%) | 9 |
Myalgia | 14/22 (63.6%) | 41 |
Neck pain | 7/22 (31.8%) | 15 |
Neck stiffness | 2/22 (9.1%) | 2 |
Pain in extremity | 10/22 (45.5%) | 15 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
Neoplasms - other, specify: basal cell carcinoma on sternum | 1/22 (4.5%) | 1 |
Nervous system disorders | ||
Concentration impairment | 1/22 (4.5%) | 1 |
Dizziness | 11/22 (50%) | 24 |
Dysgeusia | 2/22 (9.1%) | 2 |
Dysphagia | 1/22 (4.5%) | 1 |
Headache | 14/22 (63.6%) | 47 |
Memory impairment | 1/22 (4.5%) | 1 |
Nervous system disorders - Other, specify: Autonomic Postural Hypotension | 1/22 (4.5%) | 1 |
Paresthesia | 8/22 (36.4%) | 15 |
Peripheral sensory neuropathy | 3/22 (13.6%) | 3 |
Tremor | 2/22 (9.1%) | 2 |
Psychiatric disorders | ||
Agitation | 1/22 (4.5%) | 1 |
Anxiety | 2/22 (9.1%) | 2 |
Confusion (forgetfullness) | 1/22 (4.5%) | 1 |
Depression | 2/22 (9.1%) | 2 |
Insomnia | 12/22 (54.5%) | 15 |
Irritability | 1/22 (4.5%) | 1 |
Mania | 1/22 (4.5%) | 1 |
Renal and urinary disorders | ||
Acute kidney injury | 1/22 (4.5%) | 1 |
Chronic kidney disease | 11/22 (50%) | 30 |
Hematuria | 5/22 (22.7%) | 8 |
Nocturia | 3/22 (13.6%) | 3 |
Proteinuria | 2/22 (9.1%) | 2 |
Urinary frequency | 5/22 (22.7%) | 6 |
Urinary incontinence | 1/22 (4.5%) | 1 |
Urinary tract pain | 1/22 (4.5%) | 2 |
Urinary urgency | 1/22 (4.5%) | 1 |
Reproductive system and breast disorders | ||
Genital edema | 1/22 (4.5%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||
Allergic Rhinitis | 3/22 (13.6%) | 4 |
Bronchospasm | 1/22 (4.5%) | 2 |
Congestion | 2/22 (9.1%) | 4 |
Cough | 18/22 (81.8%) | 46 |
Dyspnea | 9/22 (40.9%) | 19 |
Epistaxis | 4/22 (18.2%) | 9 |
Hiccups | 1/22 (4.5%) | 2 |
Hoarseness | 6/22 (27.3%) | 7 |
Hypoxia | 1/22 (4.5%) | 1 |
Laryngeal inflammation | 1/22 (4.5%) | 1 |
Lung infection | 1/22 (4.5%) | 1 |
Nasal congestion | 9/22 (40.9%) | 13 |
Post nasal drip | 6/22 (27.3%) | 10 |
Productive cough | 6/22 (27.3%) | 15 |
Rhinorrhea | 7/22 (31.8%) | 13 |
Sleep apnea | 1/22 (4.5%) | 1 |
Sore throat | 10/22 (45.5%) | 19 |
Wheezing | 1/22 (4.5%) | 1 |
Skin and subcutaneous tissue disorders | ||
Alopecia | 2/22 (9.1%) | 2 |
Dry Skin | 2/22 (9.1%) | 2 |
Nail infection | 2/22 (9.1%) | 2 |
Periorbital edema | 1/22 (4.5%) | 1 |
Photosensitivity | 1/22 (4.5%) | 1 |
Pruritus | 3/22 (13.6%) | 9 |
Rash | 1/22 (4.5%) | 1 |
Rash acneiform | 3/22 (13.6%) | 5 |
Rash maculopapular | 7/22 (31.8%) | 18 |
Skin & subcutaneous tissue disorders - other, specify: cercarial dermatitis/swimmer's itch | 1/22 (4.5%) | 4 |
Skin and Subcutaneous tissue disorders - other, specify: Abrasion | 1/22 (4.5%) | 1 |
Skin and Subcutaneous tissue disorders - other, specify: bug bite | 3/22 (13.6%) | 4 |
Skin and Subcutaneous tissue disorders - other, specify: erythema | 1/22 (4.5%) | 1 |
Skin and Subcutaneous tissue disorders - other, specify: Laceration | 3/22 (13.6%) | 3 |
Skin and subcutaneous tissue disorders - other, specify: Skin sensitivity | 1/22 (4.5%) | 1 |
Skin and Subcutaneous tissue disorders - other, specify: Wound | 1/22 (4.5%) | 1 |
Skin induration | 1/22 (4.5%) | 1 |
Surgical and medical procedures | ||
Surgical procedure - other, specify: Biopsy /wart removal | 1/22 (4.5%) | 1 |
Surgical procedure - other, specify: biopsy, face, head, back | 1/22 (4.5%) | 1 |
Surgical procedure - other, specify: pre-cancerous areas removed | 2/22 (9.1%) | 3 |
Surgical procedure - other, specify: shaved excision of dysplastic nevus | 1/22 (4.5%) | 1 |
Vascular disorders | ||
Arterial injury | 1/22 (4.5%) | 2 |
Hot flashes | 1/22 (4.5%) | 1 |
Hypertension | 3/22 (13.6%) | 4 |
Hypotension | 1/22 (4.5%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT 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 | Vaishali Sanchorawala, MD |
---|---|
Organization | Boston Medical Center |
Phone | 617-638-8213 |
vaishali.sanchorawala@bmc.org |
- H-35360
- 54767414AMY2002