Trial Outcomes & Findings for Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis (NCT NCT00884377)
NCT ID: NCT00884377
Last Updated: 2020-01-02
Results Overview
Assess whether local heat therapy using the ThermoMed device was equivalent (clinical cure) in efficacy to 10 days of parenteral sodium stibogluconate. Clinical cure is defined as complete epithelialization of lesion. post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In addition, an "overall response" was assigned ("healed" or "not healed") based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Assessment of cure is made at 2 months after treatment
Results posted on
2020-01-02
Participant Flow
Fifty Six subjects were recruited from the Infectious Disease Clinic at Walter Reed Army Medical Center from February 2004 to March 2009. At 2 months post-treatment, subjects assessed as having failed therapy were eligible for crossover to an alternate treatment.
Participant milestones
| Measure |
Treatment With IV Sodium Stibogluconate
Subjects who had been randomized to the sodium stibogluconate group, received 10 days of treatment with sodium stibogluconate 20 mg/kg/day via intravenous infusions that were administered by health care personnel, generally in the WRAMC Infectious Disease Clinic or in the WRAMC infusion clinic.
|
Treatment With Thermomed Device
Subjects randomized to the ThermoMed arm were given one treatment session using the ThermoMed device, Model 1.8, at 50°C. A heat treatment consisted of one or more 30-second heat applications of the ThermoMed device, with the number of applications dictated by lesion size. For lesions smaller than 2 mm, a treatment consisted of only one application of the ThermoMed device. For larger lesions, a treatment involved multiple overlapping applications of the device along an imaginary line that extended across the lesion and included approximately 4 mm of apparently healthy border skin. All of a subject's cutaneous leishmaniasis lesions, up to 20, were treated
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Treatment With IV Sodium Stibogluconate
Subjects who had been randomized to the sodium stibogluconate group, received 10 days of treatment with sodium stibogluconate 20 mg/kg/day via intravenous infusions that were administered by health care personnel, generally in the WRAMC Infectious Disease Clinic or in the WRAMC infusion clinic.
|
Treatment With Thermomed Device
Subjects randomized to the ThermoMed arm were given one treatment session using the ThermoMed device, Model 1.8, at 50°C. A heat treatment consisted of one or more 30-second heat applications of the ThermoMed device, with the number of applications dictated by lesion size. For lesions smaller than 2 mm, a treatment consisted of only one application of the ThermoMed device. For larger lesions, a treatment involved multiple overlapping applications of the device along an imaginary line that extended across the lesion and included approximately 4 mm of apparently healthy border skin. All of a subject's cutaneous leishmaniasis lesions, up to 20, were treated
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Could not confirm diagnosis
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis
Baseline characteristics by cohort
| Measure |
Treatment With IV Sodium Stibogluconate
n=28 Participants
Subjects who had been randomized to the sodium stibogluconate group, received 10 days of treatment with sodium stibogluconate 20 mg/kg/day via intravenous infusions that were administered by health care personnel, generally in the WRAMC Infectious Disease Clinic or in the WRAMC infusion clinic.
|
Treatment With Thermomed Device
n=28 Participants
Subjects randomized to the ThermoMed arm were given one treatment session using the ThermoMed device, Model 1.8, at 50°C. A heat treatment consisted of one or more 30-second heat applications of the ThermoMed device, with the number of applications dictated by lesion size. For lesions smaller than 2 mm, a treatment consisted of only one application of the ThermoMed device. For larger lesions, a treatment involved multiple overlapping applications of the device along an imaginary line that extended across the lesion and included approximately 4 mm of apparently healthy border skin. All of a subject's cutaneous leishmaniasis lesions, up to 20, were treated
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.0 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
28.9 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
27.9 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessment of cure is made at 2 months after treatmentPopulation: A sample size of 27 subjects per treatment group was planned based on the assumption that the cure rate in the heat treatment arm would be 73% (Navin et al., 1990), compared to a 99% cure rate in the sodium stibogluconate arm (Wortmann et al., 2002).
Assess whether local heat therapy using the ThermoMed device was equivalent (clinical cure) in efficacy to 10 days of parenteral sodium stibogluconate. Clinical cure is defined as complete epithelialization of lesion. post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In addition, an "overall response" was assigned ("healed" or "not healed") based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test.
Outcome measures
| Measure |
Sodium Stibogluconate
n=28 Participants
Sodium Stibogluconate group
|
ThermoMed Device
n=28 Participants
ThermoMed device group
|
Study Day 1: ThermoMed
Day 1: TherrmoMed group
|
Study Day 10: ThermoMed
Day 10: ThermoMed group
|
|---|---|---|---|---|
|
Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure
Healed
|
22 Participants
|
18 Participants
|
—
|
—
|
|
Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure
Not Healed
|
5 Participants
|
9 Participants
|
—
|
—
|
|
Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure
Not Applicable
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure
Cured
|
13 Participants
|
11 Participants
|
—
|
—
|
|
Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure
Not Cured
|
13 Participants
|
14 Participants
|
—
|
—
|
|
Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure
Not Evaluable
|
2 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsDetermine the equivalence of efficacy (clinical cure) of ThermoMed treatment vs sodium stibogluconate in clinical response of all skin lesions at 12 months. Clinical cure is defined as complete epithelialization of lesion. Post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In addition, an "overall response" was assigned ("healed" or "not healed") based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test.
Outcome measures
| Measure |
Sodium Stibogluconate
n=28 Participants
Sodium Stibogluconate group
|
ThermoMed Device
n=28 Participants
ThermoMed device group
|
Study Day 1: ThermoMed
Day 1: TherrmoMed group
|
Study Day 10: ThermoMed
Day 10: ThermoMed group
|
|---|---|---|---|---|
|
Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure
Healed
|
25 Participants
|
23 Participants
|
—
|
—
|
|
Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure
Not Healed
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure
Not Applicable
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure
Clincally Cured
|
23 Participants
|
21 Participants
|
—
|
—
|
|
Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure
Not Clinically Cured
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure
Not Evaluable
|
3 Participants
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 3, 7 and 10Population: Data ia showing only subjects with specified solicited symptoms on Days 3, 7 and 10. Collective count of participants for SSG is 53 and 28 for ThermoMed over all reported days.
To compare the toxicity profiles of ThermoMed treatment versus parenteral sodium stibogluconate therapy thru specific solicited adverse events
Outcome measures
| Measure |
Sodium Stibogluconate
n=28 Participants
Sodium Stibogluconate group
|
ThermoMed Device
n=28 Participants
ThermoMed device group
|
Study Day 1: ThermoMed
Day 1: TherrmoMed group
|
Study Day 10: ThermoMed
Day 10: ThermoMed group
|
|---|---|---|---|---|
|
Number of Participants With Solicited Adverse Events
Other : Day 3
|
3 subjects showing specified symptoms
|
2 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Myalgias : Day 3
|
4 subjects showing specified symptoms
|
1 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Myalgias : Day 7
|
3 subjects showing specified symptoms
|
0 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Myalgias : Day 10
|
5 subjects showing specified symptoms
|
0 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Arthralgias : Day 3
|
4 subjects showing specified symptoms
|
2 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Arthralgias : Day 7
|
11 subjects showing specified symptoms
|
2 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Arthralgias : Day 10
|
7 subjects showing specified symptoms
|
2 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Nausea : Day 3
|
3 subjects showing specified symptoms
|
1 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Nausea : Day 7
|
4 subjects showing specified symptoms
|
0 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Nausea : Day 10
|
1 subjects showing specified symptoms
|
1 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Vomiting : Day 3
|
1 subjects showing specified symptoms
|
0 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Vomiting : Day 7
|
2 subjects showing specified symptoms
|
0 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Vomiting : Day 10
|
0 subjects showing specified symptoms
|
0 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Abdominal Pain : Day 3
|
2 subjects showing specified symptoms
|
0 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Abdominal Pain : Day 7
|
3 subjects showing specified symptoms
|
0 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Abdominal Pain : Day 10
|
2 subjects showing specified symptoms
|
1 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Headache : Day 3
|
7 subjects showing specified symptoms
|
2 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Headache : Day 7
|
9 subjects showing specified symptoms
|
2 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Headache : Day 10
|
5 subjects showing specified symptoms
|
2 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Diarrhea : Day 3
|
2 subjects showing specified symptoms
|
1 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Diarrhea : Day 7
|
3 subjects showing specified symptoms
|
0 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Diarrhea : Day 10
|
3 subjects showing specified symptoms
|
1 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Rash : Day 3
|
2 subjects showing specified symptoms
|
1 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Rash : Day 7
|
2 subjects showing specified symptoms
|
0 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Rash : Day 10
|
3 subjects showing specified symptoms
|
1 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Fever : Day 3
|
0 subjects showing specified symptoms
|
0 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Fever : Day 7
|
2 subjects showing specified symptoms
|
0 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Fever : Day 10
|
0 subjects showing specified symptoms
|
0 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Fatigue : Day 3
|
17 subjects showing specified symptoms
|
3 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Fatigue : Day 7
|
11 subjects showing specified symptoms
|
1 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Fatigue : Day 10
|
9 subjects showing specified symptoms
|
3 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Chest Pain : Day 3
|
1 subjects showing specified symptoms
|
0 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Chest Pain : Day 7
|
0 subjects showing specified symptoms
|
0 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Chest Pain : Day 10
|
0 subjects showing specified symptoms
|
0 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Other : Day 7
|
6 subjects showing specified symptoms
|
5 subjects showing specified symptoms
|
—
|
—
|
|
Number of Participants With Solicited Adverse Events
Other : Day 10
|
2 subjects showing specified symptoms
|
7 subjects showing specified symptoms
|
—
|
—
|
SECONDARY outcome
Timeframe: day 1 and day 10Population: Populations of T-cells CD3+CD8, CD19, CD16+CD56 on study days 1 and 10
Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns.
Outcome measures
| Measure |
Sodium Stibogluconate
n=27 Participants
Sodium Stibogluconate group
|
ThermoMed Device
n=26 Participants
ThermoMed device group
|
Study Day 1: ThermoMed
n=27 Participants
Day 1: TherrmoMed group
|
Study Day 10: ThermoMed
n=27 Participants
Day 10: ThermoMed group
|
|---|---|---|---|---|
|
Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments
ABS CD3+CD8 (cells/uL)
|
515.89 populations of T-cells
Interval 97.0 to 950.0
|
534.19 populations of T-cells
Interval 228.0 to 1150.0
|
368.74 populations of T-cells
Interval 63.0 to 1092.0
|
500.15 populations of T-cells
Interval 259.0 to 754.0
|
|
Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments
ABS CD19 (cells/uL)
|
375.37 populations of T-cells
Interval 121.0 to 806.0
|
328.27 populations of T-cells
Interval 145.0 to 613.0
|
213.85 populations of T-cells
Interval 76.0 to 447.0
|
274.70 populations of T-cells
Interval 172.0 to 513.0
|
|
Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments
ABS CD16+CD56 (cells/uL)
|
196.52 populations of T-cells
Interval 66.0 to 474.0
|
207.62 populations of T-cells
Interval 111.0 to 406.0
|
137.74 populations of T-cells
Interval 49.0 to 603.0
|
221.96 populations of T-cells
Interval 122.0 to 482.0
|
SECONDARY outcome
Timeframe: day 1 and day 10Population: Percent of T-cells CD3+CD8, CD19, CD16+CD56 on study days 1 and 10
Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns.
Outcome measures
| Measure |
Sodium Stibogluconate
n=27 Participants
Sodium Stibogluconate group
|
ThermoMed Device
n=26 Participants
ThermoMed device group
|
Study Day 1: ThermoMed
n=27 Participants
Day 1: TherrmoMed group
|
Study Day 10: ThermoMed
n=27 Participants
Day 10: ThermoMed group
|
|---|---|---|---|---|
|
Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments
CD3+CD8 (%)
|
25.07 % of T-cells
Interval 9.0 to 41.0
|
26.54 % of T-cells
Interval 16.0 to 38.0
|
25.67 % of T-cells
Interval 10.0 to 40.0
|
26.85 % of T-cells
Interval 15.0 to 38.0
|
|
Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments
CD19 (%)
|
17.96 % of T-cells
Interval 8.0 to 37.0
|
16.73 % of T-cells
Interval 8.0 to 31.0
|
15.30 % of T-cells
Interval 8.0 to 32.0
|
15.11 % of T-cells
Interval 9.0 to 25.0
|
|
Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments
CD16+CD56 (%)
|
9.67 % of T-cells
Interval 4.0 to 16.0
|
10.73 % of T-cells
Interval 6.0 to 19.0
|
9.81 % of T-cells
Interval 3.0 to 24.0
|
11.74 % of T-cells
Interval 6.0 to 25.0
|
SECONDARY outcome
Timeframe: at baseline before treatmentEvaluate the feasibility of using species-specific PCR as a rapid diagnostic assay for L. major infection. The comparator modalities were: histopathology (identification of amastigotes); speciation determined through culture and isoenzyme analysis; and genus and species-specific PCR. Species PCR testing was performed at baseline to allow for the identification of L. major as each subject's infecting parasite. If an L. major infection could not be confirmed in a subject's lesion(s), then that subject could not be treated under this protocol.
Outcome measures
| Measure |
Sodium Stibogluconate
n=28 Participants
Sodium Stibogluconate group
|
ThermoMed Device
n=28 Participants
ThermoMed device group
|
Study Day 1: ThermoMed
Day 1: TherrmoMed group
|
Study Day 10: ThermoMed
Day 10: ThermoMed group
|
|---|---|---|---|---|
|
Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial
Histopathology: Amastigotes absent
|
10 Participants
|
6 Participants
|
—
|
—
|
|
Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial
Histopathology: Amastigotes present
|
18 Participants
|
22 Participants
|
—
|
—
|
|
Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial
Culture: Not done
|
4 Participants
|
5 Participants
|
—
|
—
|
|
Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial
Culture: Unknown
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial
Culture: Negative
|
6 Participants
|
4 Participants
|
—
|
—
|
|
Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial
Culture: Positive
|
18 Participants
|
18 Participants
|
—
|
—
|
|
Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial
Culture/Isoenzyme Analysis: L.major = Positive
|
12 Participants
|
12 Participants
|
—
|
—
|
|
Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial
Culture/Isoenzyme analysis: Unknown Leish species
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial
Culture/Isoenzyme analysis: Not done
|
4 Participants
|
4 Participants
|
—
|
—
|
|
Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial
PCR (Genus) = Positive for Leish genus
|
28 Participants
|
28 Participants
|
—
|
—
|
|
Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial
PCR (Species) = Positive for L.major species
|
27 Participants
|
28 Participants
|
—
|
—
|
|
Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial
PCR (Species) = Unknown
|
1 Participants
|
0 Participants
|
—
|
—
|
Adverse Events
Sodium Stibogluconate Intravenous
Serious events: 5 serious events
Other events: 28 other events
Deaths: 0 deaths
ThermoMed Device
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sodium Stibogluconate Intravenous
n=28 participants at risk
20 mg/kg/day Sodium stibogluconate intravenous
Sodium stibogluconate (Pentostam): intravenous 20 mg/kg/day for 10 days
|
ThermoMed Device
n=28 participants at risk
ThermoMed device, single heat treatment at 50 degrees Celsius
ThermoMed: ThermoMed heat treatment device, one treatment
|
|---|---|---|
|
Gastrointestinal disorders
Accute gastroenteritis
|
3.6%
1/28 • Number of events 1 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis, left acromioclavicular joint
|
3.6%
1/28 • Number of events 1 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Injury, poisoning and procedural complications
Injury, spine trauma
|
3.6%
1/28 • Number of events 1 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Infections and infestations
Lobar pneumonia
|
3.6%
1/28 • Number of events 1 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transanal resection of carcinoid tumor
|
3.6%
1/28 • Number of events 1 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Immune system disorders
Crohn's disease exacerbation
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
3.6%
1/28 • Number of events 1 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Skin and subcutaneous tissue disorders
Basal cell carcinoma, superficial
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
3.6%
1/28 • Number of events 1 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
Other adverse events
| Measure |
Sodium Stibogluconate Intravenous
n=28 participants at risk
20 mg/kg/day Sodium stibogluconate intravenous
Sodium stibogluconate (Pentostam): intravenous 20 mg/kg/day for 10 days
|
ThermoMed Device
n=28 participants at risk
ThermoMed device, single heat treatment at 50 degrees Celsius
ThermoMed: ThermoMed heat treatment device, one treatment
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Lesion site blister
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
89.3%
25/28 • Number of events 25 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Vascular disorders
No blanching with pressure
|
3.6%
1/28 • Number of events 1 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
64.3%
18/28 • Number of events 18 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Skin and subcutaneous tissue disorders
Site erythema
|
17.9%
5/28 • Number of events 5 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
75.0%
21/28 • Number of events 21 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Injury, poisoning and procedural complications
Site eschar
|
32.1%
9/28 • Number of events 9 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
89.3%
25/28 • Number of events 25 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Infections and infestations
Site infection
|
3.6%
1/28 • Number of events 1 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
17.9%
5/28 • Number of events 5 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Skin and subcutaneous tissue disorders
Site keloid formation
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
General disorders
Site pain
|
7.1%
2/28 • Number of events 2 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
39.3%
11/28 • Number of events 11 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Skin and subcutaneous tissue disorders
Site papules
|
21.4%
6/28 • Number of events 6 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Injury, poisoning and procedural complications
Site plaque
|
35.7%
10/28 • Number of events 10 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
25.0%
7/28 • Number of events 7 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Skin and subcutaneous tissue disorders
Site pruritus
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
21.4%
6/28 • Number of events 6 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Infections and infestations
Satellite lesions
|
7.1%
2/28 • Number of events 2 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Skin and subcutaneous tissue disorders
Site scaley
|
39.3%
11/28 • Number of events 11 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
21.4%
6/28 • Number of events 6 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
General disorders
Site tenderness
|
7.1%
2/28 • Number of events 2 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
17.9%
5/28 • Number of events 5 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Injury, poisoning and procedural complications
Site ulcer
|
39.3%
11/28 • Number of events 11 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
50.0%
14/28 • Number of events 14 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Site verrucous
|
7.1%
2/28 • Number of events 2 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
General disorders
Site weeping
|
7.1%
2/28 • Number of events 2 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
82.1%
23/28 • Number of events 23 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Injury, poisoning and procedural complications
Site oedema
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
14.3%
4/28 • Number of events 4 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Cardiac disorders
Tachycardia
|
17.9%
5/28 • Number of events 5 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Cardiac disorders
Ventricular hypertrophy
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
7/28 • Number of events 7 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
3.6%
1/28 • Number of events 1 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
7/28 • Number of events 7 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
7.1%
2/28 • Number of events 2 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
8/28 • Number of events 8 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
7.1%
2/28 • Number of events 2 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Gastrointestinal disorders
Vomiting
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
General disorders
Chest pain
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
General disorders
Fatigue
|
100.0%
28/28 • Number of events 28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
25.0%
7/28 • Number of events 7 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
General disorders
Pyrexia
|
14.3%
4/28 • Number of events 4 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
General disorders
Site extravasation
|
17.9%
5/28 • Number of events 5 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Hepatobiliary disorders
Chemical hepatitis
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Investigations
Amylase increased
|
67.9%
19/28 • Number of events 19 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Investigations
Lipase increased
|
82.1%
23/28 • Number of events 23 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Investigations
ALT increased
|
46.4%
13/28 • Number of events 13 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Investigations
AST increased
|
32.1%
9/28 • Number of events 9 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Investigations
EKG T-wave abnormal
|
7.1%
2/28 • Number of events 2 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Investigations
QRS axis abnormal
|
14.3%
4/28 • Number of events 4 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
14.3%
4/28 • Number of events 4 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Investigations
WBC decreased
|
32.1%
9/28 • Number of events 9 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
7.1%
2/28 • Number of events 2 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Investigations
Eosinophil count increased
|
7.1%
2/28 • Number of events 2 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Investigations
Monocyte count increased
|
25.0%
7/28 • Number of events 7 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
3.6%
1/28 • Number of events 1 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Investigations
Platelet count decreased
|
28.6%
8/28 • Number of events 8 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
7.1%
2/28 • Number of events 2 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Investigations
Albumin decreased
|
21.4%
6/28 • Number of events 6 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Investigations
Chloride increased
|
17.9%
5/28 • Number of events 5 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
3.6%
1/28 • Number of events 1 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Investigations
Creatine phosphokinase increased
|
7.1%
2/28 • Number of events 2 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
78.6%
22/28 • Number of events 22 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
21.4%
6/28 • Number of events 6 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
42.9%
12/28 • Number of events 12 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
3.6%
1/28 • Number of events 1 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Nervous system disorders
Headache
|
75.0%
21/28 • Number of events 21 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
21.4%
6/28 • Number of events 6 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
7.1%
2/28 • Number of events 2 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
7/28 • Number of events 7 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
7.1%
2/28 • Number of events 2 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
Vascular disorders
Dizziness
|
10.7%
3/28 • Number of events 3 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
3.6%
1/28 • Number of events 1 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
|
General disorders
Fever
|
7.1%
2/28 • Number of events 2 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
0.00%
0/28 • Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
|
Additional Information
Dr. Naomi Aronson, Principal Investigator
Walter Reed Army Medical Center
Phone: 202-782-8691
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place