Trial Outcomes & Findings for Efficacy and Microfilaricidal Kinetics of Imatinib for the Treatment of Loa Loa (NCT NCT02644525)
NCT ID: NCT02644525
Last Updated: 2022-06-07
Results Overview
Percent of baseline Loa loa microfilariae as determined by concentrated peripheral blood smear. Daily measurements will be taken the first week, followed by measurements at day 14 and day 21
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Days 1-7, 14, 21
Results posted on
2022-06-07
Participant Flow
Participant milestones
| Measure |
Placebo
5 subjects given placebo as a single dose
|
Imatinib 200mg
Participants given a single dose of 200mg PO imatinib
|
Imatinib 400mg
Participants given a single dose of 400mg PO imatinib
|
Imatinib 600mg
Participants given a single dose of 600mg PO imatinib
|
|---|---|---|---|---|
|
Group 1
STARTED
|
2
|
5
|
0
|
0
|
|
Group 1
COMPLETED
|
2
|
5
|
0
|
0
|
|
Group 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Group 2
STARTED
|
2
|
0
|
5
|
0
|
|
Group 2
COMPLETED
|
2
|
0
|
5
|
0
|
|
Group 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Group 3
STARTED
|
1
|
0
|
0
|
5
|
|
Group 3
COMPLETED
|
1
|
0
|
0
|
5
|
|
Group 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Microfilaricidal Kinetics of Imatinib for the Treatment of Loa Loa
Baseline characteristics by cohort
| Measure |
Placebo
n=5 Participants
5 subjects given placebo as a single dose
|
Imatinib 200mg
n=5 Participants
5 subjects given 200mg PO imatinib as a single dose
|
Imatinib 400mg
n=5 Participants
5 subjects given 400mg PO imatinib as a single dose
|
Imatinib 600mg
n=5 Participants
5 subjects given 600mg PO imatinib as a single dose
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=113 Participants
|
5 Participants
n=163 Participants
|
5 Participants
n=160 Participants
|
5 Participants
n=483 Participants
|
20 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
50 years
n=113 Participants
|
51 years
n=163 Participants
|
50 years
n=160 Participants
|
45 years
n=483 Participants
|
49 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=113 Participants
|
5 Participants
n=163 Participants
|
5 Participants
n=160 Participants
|
3 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=113 Participants
|
5 Participants
n=163 Participants
|
5 Participants
n=160 Participants
|
5 Participants
n=483 Participants
|
20 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
Cameroon
|
5 participants
n=113 Participants
|
5 participants
n=163 Participants
|
5 participants
n=160 Participants
|
5 participants
n=483 Participants
|
20 participants
n=36 Participants
|
|
Loa loa mid-day blood microfilariae count
|
1447 microfilariae/mL
n=113 Participants
|
1329 microfilariae/mL
n=163 Participants
|
2154 microfilariae/mL
n=160 Participants
|
1328 microfilariae/mL
n=483 Participants
|
1532 microfilariae/mL
n=36 Participants
|
PRIMARY outcome
Timeframe: Days 1-7, 14, 21Population: In a two cases (Day 2 for Imatinib 200mg, Day 7 for Imatinib 400mg), some values were missing.
Percent of baseline Loa loa microfilariae as determined by concentrated peripheral blood smear. Daily measurements will be taken the first week, followed by measurements at day 14 and day 21
Outcome measures
| Measure |
Placebo
n=5 Participants
Single dose of placebo
|
Imatinib 200mg
n=5 Participants
Single dose of imatinib 200mg po
|
Imatinib 400mg
n=5 Participants
Single dose of imatinib 400mg po
|
Imatinib 600mg
n=5 Participants
Single dose of imatinib 600mg po
|
|---|---|---|---|---|
|
Percent of Baseline Loa Loa Microfilariae
Day 1
|
88.7 percentage of baseline microfilariae
Interval 52.2 to 150.8
|
114.5 percentage of baseline microfilariae
Interval 81.2 to 161.4
|
104.7 percentage of baseline microfilariae
Interval 82.4 to 133.1
|
102.2 percentage of baseline microfilariae
Interval 56.0 to 186.5
|
|
Percent of Baseline Loa Loa Microfilariae
Day 2
|
88.1 percentage of baseline microfilariae
Interval 61.7 to 125.7
|
96.8 percentage of baseline microfilariae
Interval 48.0 to 195.5
|
98.0 percentage of baseline microfilariae
Interval 70.6 to 135.9
|
97.8 percentage of baseline microfilariae
Interval 53.3 to 179.5
|
|
Percent of Baseline Loa Loa Microfilariae
Day 3
|
84.6 percentage of baseline microfilariae
Interval 49.6 to 144.4
|
102.8 percentage of baseline microfilariae
Interval 70.8 to 149.1
|
84.0 percentage of baseline microfilariae
Interval 51.9 to 136.0
|
84.8 percentage of baseline microfilariae
Interval 61.4 to 117.0
|
|
Percent of Baseline Loa Loa Microfilariae
Day 4
|
73.3 percentage of baseline microfilariae
Interval 46.5 to 115.5
|
108.5 percentage of baseline microfilariae
Interval 72.3 to 163.0
|
59.7 percentage of baseline microfilariae
Interval 23.5 to 151.7
|
88.1 percentage of baseline microfilariae
Interval 62.1 to 125.1
|
|
Percent of Baseline Loa Loa Microfilariae
Day 5
|
79.9 percentage of baseline microfilariae
Interval 40.6 to 157.2
|
95.5 percentage of baseline microfilariae
Interval 67.5 to 135.2
|
76.9 percentage of baseline microfilariae
Interval 22.7 to 260.5
|
89.1 percentage of baseline microfilariae
Interval 55.8 to 142.3
|
|
Percent of Baseline Loa Loa Microfilariae
Day 6
|
80.4 percentage of baseline microfilariae
Interval 50.3 to 128.5
|
107.0 percentage of baseline microfilariae
Interval 72.4 to 158.0
|
62.3 percentage of baseline microfilariae
Interval 16.8 to 230.8
|
84.1 percentage of baseline microfilariae
Interval 49.1 to 144.1
|
|
Percent of Baseline Loa Loa Microfilariae
Day 7
|
76.9 percentage of baseline microfilariae
Interval 52.2 to 113.2
|
78.9 percentage of baseline microfilariae
Interval 41.9 to 148.5
|
136.0 percentage of baseline microfilariae
missing data, not enough non-missing data to calculate confidence interval
|
83.3 percentage of baseline microfilariae
Interval 70.2 to 98.9
|
|
Percent of Baseline Loa Loa Microfilariae
Day 14
|
100.6 percentage of baseline microfilariae
Interval 52.2 to 193.7
|
83.7 percentage of baseline microfilariae
Interval 51.9 to 135.0
|
81.8 percentage of baseline microfilariae
Interval 30.8 to 217.4
|
94.4 percentage of baseline microfilariae
Interval 65.2 to 136.6
|
|
Percent of Baseline Loa Loa Microfilariae
Day 21
|
66.8 percentage of baseline microfilariae
Interval 38.1 to 116.9
|
86.5 percentage of baseline microfilariae
Interval 36.8 to 203.2
|
107.6 percentage of baseline microfilariae
Interval 66.1 to 175.2
|
97.4 percentage of baseline microfilariae
Interval 73.5 to 129.1
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Imatinib 200mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Imatinib 400mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Imatinib 600mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=5 participants at risk
Single dose of placebo
|
Imatinib 200mg
n=5 participants at risk
Single dose of imatinib 200mg po
|
Imatinib 400mg
n=5 participants at risk
Single dose of imatinib 400mg po
|
Imatinib 600mg
n=5 participants at risk
Single dose of imatinib 600mg po
|
|---|---|---|---|---|
|
Cardiac disorders
Hypertension
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Immune system disorders
Neutropenia
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Blood and lymphatic system disorders
Pulmonary embolism
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
Other adverse events
| Measure |
Placebo
n=5 participants at risk
Single dose of placebo
|
Imatinib 200mg
n=5 participants at risk
Single dose of imatinib 200mg po
|
Imatinib 400mg
n=5 participants at risk
Single dose of imatinib 400mg po
|
Imatinib 600mg
n=5 participants at risk
Single dose of imatinib 600mg po
|
|---|---|---|---|---|
|
General disorders
Headache
|
40.0%
2/5 • Number of events 2 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
40.0%
2/5 • Number of events 2 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Hepatobiliary disorders
Alkaline phosphatase increased
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
40.0%
2/5 • Number of events 2 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Gastrointestinal disorders
Alanine aminotransferase increased
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
40.0%
2/5 • Number of events 2 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
40.0%
2/5 • Number of events 3 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
40.0%
2/5 • Number of events 2 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
60.0%
3/5 • Number of events 4 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
General disorders
Anorexia
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
40.0%
2/5 • Number of events 2 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
80.0%
4/5 • Number of events 5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
40.0%
2/5 • Number of events 2 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Hepatobiliary disorders
Blood bilirubin increased
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
General disorders
Chills
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
General disorders
Fatigue
|
40.0%
2/5 • Number of events 2 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
40.0%
2/5 • Number of events 2 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
General disorders
Fever
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
General disorders
Gingival pain
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Cardiac disorders
Hypertension
|
40.0%
2/5 • Number of events 4 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
60.0%
3/5 • Number of events 5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
60.0%
3/5 • Number of events 6 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 2 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Renal and urinary disorders
Hyponatremia
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
40.0%
2/5 • Number of events 2 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
General disorders
Insomnia
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Blood and lymphatic system disorders
Lymphedema
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Blood and lymphatic system disorders
Lymphocyte count increased
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
40.0%
2/5 • Number of events 3 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Infections and infestations
Malaria
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Injury, poisoning and procedural complications
Mild wound
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 2 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
40.0%
2/5 • Number of events 2 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
40.0%
2/5 • Number of events 5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
80.0%
4/5 • Number of events 6 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
60.0%
3/5 • Number of events 4 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
60.0%
3/5 • Number of events 5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
40.0%
2/5 • Number of events 2 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
40.0%
2/5 • Number of events 2 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Renal and urinary disorders
Proteinuria
|
20.0%
1/5 • Number of events 2 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
40.0%
2/5 • Number of events 4 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
40.0%
2/5 • Number of events 4 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 2 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Cardiac disorders
Sinus Tachycardia
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
1/5 • Number of events 2 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
20.0%
1/5 • Number of events 1 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
0.00%
0/5 • 3 months
Common Terminology Criteria for Adverse Events v5.0. Refer to protocol for schedule of labs and history and physical exams to collect this data over 3 months.
|
Additional Information
Elise O'Connell, MD, Principal Investigator
Laboratory of Parasitic Diseases, NIAID/NIH
Phone: 301-661-0172
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place