Trial Outcomes & Findings for Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study (NCT NCT02563769)
NCT ID: NCT02563769
Last Updated: 2023-11-03
Results Overview
Rates of occurrence of serious adverse events across the different treatments: Day 1-IV cocaine only; Day 2.3 and 4 treatment with either PBO, CLAV 250mg or CLAV 500mg depending on randomization; Day 5 CLAV 750mg, Day 10 Follow-up appointment See Adverse Event section for reporting of mild-moderate AEs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
6 Days (Study Days 1, 2, 3, 4, 5, 10)
Results posted on
2023-11-03
Participant Flow
This was an inpatient study at Temple University, Episcopal Hospital in Philadelphia, Pennsylvania with subjects recruited between 10/24/2016 and 6/04/2018.
10 subjects were randomized to one of three treatment arms in a double masked method.
Participant milestones
| Measure |
Placebo; Clav 250mg, Then Clav 500mg
Clavulanic acid (Clav) OR Placebo to be given in combination with daily intravenous cocaine; Day #1 IV cocaine only; Day #2: Placebo mg; Day #3: Clav 250 mg; Day #4: Clav 500mg
|
Clav 250mg; Placebo; Then Clav 500mg
Clavulanic acid (Clav) OR Placebo to be given in combination with daily intravenous cocaine; Day #2: Clav 250 mg; Day #3: Placebo; Day #4: Clav 500 mg
|
Clav 250mg; Clav 500mg; Then Placebo
Clavulanic acid (Clav) OR Placebo to be given in combination with daily intravenous cocaine; Day 1# IV cocaine only; Day #2: Clav 250 mg; Day #3: Clav 500 mg; Day #4: Placebo
|
|---|---|---|---|
|
IV Cocaine Only (Day 1)
STARTED
|
3
|
3
|
4
|
|
IV Cocaine Only (Day 1)
COMPLETED
|
3
|
3
|
4
|
|
IV Cocaine Only (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
|
FIrst Treatment (Day 2)
STARTED
|
3
|
3
|
4
|
|
FIrst Treatment (Day 2)
COMPLETED
|
3
|
3
|
4
|
|
FIrst Treatment (Day 2)
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Treatment (Day 3)
STARTED
|
3
|
3
|
4
|
|
Second Treatment (Day 3)
COMPLETED
|
3
|
3
|
4
|
|
Second Treatment (Day 3)
NOT COMPLETED
|
0
|
0
|
0
|
|
Third Treatment (Day 4)
STARTED
|
3
|
3
|
4
|
|
Third Treatment (Day 4)
COMPLETED
|
3
|
3
|
4
|
|
Third Treatment (Day 4)
NOT COMPLETED
|
0
|
0
|
0
|
|
Added 750mg Dose of CLAV (Day 5)
STARTED
|
1
|
1
|
3
|
|
Added 750mg Dose of CLAV (Day 5)
COMPLETED
|
1
|
1
|
2
|
|
Added 750mg Dose of CLAV (Day 5)
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo; Clav 250mg, Then Clav 500mg
Clavulanic acid (Clav) OR Placebo to be given in combination with daily intravenous cocaine; Day #1 IV cocaine only; Day #2: Placebo mg; Day #3: Clav 250 mg; Day #4: Clav 500mg
|
Clav 250mg; Placebo; Then Clav 500mg
Clavulanic acid (Clav) OR Placebo to be given in combination with daily intravenous cocaine; Day #2: Clav 250 mg; Day #3: Placebo; Day #4: Clav 500 mg
|
Clav 250mg; Clav 500mg; Then Placebo
Clavulanic acid (Clav) OR Placebo to be given in combination with daily intravenous cocaine; Day 1# IV cocaine only; Day #2: Clav 250 mg; Day #3: Clav 500 mg; Day #4: Placebo
|
|---|---|---|---|
|
Added 750mg Dose of CLAV (Day 5)
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study
Baseline characteristics by cohort
| Measure |
Clavulanic Acid (CLAV) 250mg, CLAV 500mg Then Placebo (PBO)
n=3 Participants
Clavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Clavulanic Acid 250 mg (low dose); Day #3: Clavulanic Acid 500 mg; Day #4: Placebo
Clavulanic acid
Intravenous cocaine
Placebo
|
CLAV 250mg, PBO, Then CLAV 500mg
n=3 Participants
Clavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Clavulanic Acid 250 mg (low dose); Day #3: Placebo; Day #4: Clavulanic Acid 500 mg
Clavulanic acid
Intravenous cocaine
Placebo
|
PBO, CLAV 250mg Then CLAV 500mg
n=4 Participants
Clavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Placebo; Day #3: Clavulanic Acid 250 mg (low dose); Day #4: Clavulanic Acid 500 mg
Clavulanic acid
Intravenous cocaine
Placebo
|
Total
n=10 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
50 years
n=5 Participants
|
53 years
n=7 Participants
|
51 years
n=5 Participants
|
51 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Education Level
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 Days (Study Days 1, 2, 3, 4, 5, 10)Population: Participants were adults (18-65) with current cocaine use disorder who were recruited from the greater Philadelphia area.
Rates of occurrence of serious adverse events across the different treatments: Day 1-IV cocaine only; Day 2.3 and 4 treatment with either PBO, CLAV 250mg or CLAV 500mg depending on randomization; Day 5 CLAV 750mg, Day 10 Follow-up appointment See Adverse Event section for reporting of mild-moderate AEs.
Outcome measures
| Measure |
Day 1 - IV Cocaine Only
n=10 Participants
Subjects received 20mg IV infusion of cocaine and then 40mg IV cocaine at least 2hours 45 minutes after initial infusion
|
Placebo (PBO)
n=10 Participants
PBO (followed by IV cocaine given 1 hour (hr) later) was given either on day 2, day 3 or day 4 according to the protocol
|
CLAV 250mg
n=10 Participants
CLAV 250mg (followed by IV cocaine given 1 hr later) was given either on day 2, day 3 or day 4 according to the protocol
|
CLAV 500mg
n=10 Participants
CLAV 500mg (followed by IV cocaine given 1 hr later) was given either on day 2, day 3 or day 4 according to the protocol
|
Day 5--CLAV 750mg
n=5 Participants
CLAV 750mg (followed by IV cocaine given 1 hr later) was given on day 5 according to version 2.3 of the protocol.
|
Day 10--Follow up
n=10 Participants
5-6 days after discharge, subjects returned for a follow up visit to assess adverse events
|
|---|---|---|---|---|---|---|
|
Number of Participants With Severe Adverse Events (AEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 Days (Study Days 2, 3, 4, 5)Population: 10 participants were randomized to receive PBO or CLAV 250mg or 500mg on days 2,3 and 4 followed one hour later by IV infusion of cocaine. Part way through the study, a 5th day was added giving CLAV 750mg 1hr before the cocaine infusion (Protocol V2.3). Five participants were eligible for Day 5 but one had technical issues with the cocaine infusion and did not receive the full cocaine dose, so that subject is excluded from the report of day 5 effects.
IV cocaine was infused 1 hour following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg and vital signs were checked at -15min,-10min, -5 min preinfusion of IV cocaine and then every 2 min for the first 30 minutes, then every 15min through 150 minutes post-infusion. The mean heart rate (HR) at 2 minutes post IV cocaine infusion and the maximum (max) change in heart rate from baseline pre-infusion are reported (peak heart rate post-infusion minus baseline heart rate pre-infusion) are reported.
Outcome measures
| Measure |
Day 1 - IV Cocaine Only
n=10 Participants
Subjects received 20mg IV infusion of cocaine and then 40mg IV cocaine at least 2hours 45 minutes after initial infusion
|
Placebo (PBO)
n=10 Participants
PBO (followed by IV cocaine given 1 hour (hr) later) was given either on day 2, day 3 or day 4 according to the protocol
|
CLAV 250mg
n=10 Participants
CLAV 250mg (followed by IV cocaine given 1 hr later) was given either on day 2, day 3 or day 4 according to the protocol
|
CLAV 500mg
n=4 Participants
CLAV 500mg (followed by IV cocaine given 1 hr later) was given either on day 2, day 3 or day 4 according to the protocol
|
Day 5--CLAV 750mg
CLAV 750mg (followed by IV cocaine given 1 hr later) was given on day 5 according to version 2.3 of the protocol.
|
Day 10--Follow up
5-6 days after discharge, subjects returned for a follow up visit to assess adverse events
|
|---|---|---|---|---|---|---|
|
Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing
HR at 2 min
|
82.2 beats per minute
Standard Deviation 14.7
|
78.0 beats per minute
Standard Deviation 5.7
|
86.8 beats per minute
Standard Deviation 13.0
|
91.0 beats per minute
Standard Deviation 14.7
|
—
|
—
|
|
Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing
Max change in HR from baseline
|
26.3 beats per minute
Standard Deviation 22.6
|
29.8 beats per minute
Standard Deviation 19.2
|
32.0 beats per minute
Standard Deviation 26.3
|
27.7 beats per minute
Standard Deviation 24.7
|
—
|
—
|
PRIMARY outcome
Timeframe: 4 Days (Study Days 2, 3, 4, 5)Population: 10 participants were randomized to receive PBO or CLAV 250mg or 500mg on days 2,3 and 4 followed one hour later by IV infusion of cocaine. Part way through the study, a 5th day was added giving CLAV 750mg 1hr before the cocaine infusion (Protocol V2.3). Five participants were eligible for Day 5 but one had technical issues with the cocaine infusion and did not receive the full cocaine dose, so that subject is excluded from the report of day 5 effects.
IV cocaine was infused 1 hour following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg and vital signs were checked at -15min,-10min, -5 min pre-infusion of IV cocaine and then every 2 min for the first 30 minutes, then every 15min through 150 minutes post-infusion. The mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 2 minutes post IV cocaine infusion are reported. Also, the maximum (max) change in SBP snd DBP from baseline pre-infusion are reported (peak SBP or DBP post-infusion minus baseline SBP or DBP pre-infusion) are reported.
Outcome measures
| Measure |
Day 1 - IV Cocaine Only
n=10 Participants
Subjects received 20mg IV infusion of cocaine and then 40mg IV cocaine at least 2hours 45 minutes after initial infusion
|
Placebo (PBO)
n=10 Participants
PBO (followed by IV cocaine given 1 hour (hr) later) was given either on day 2, day 3 or day 4 according to the protocol
|
CLAV 250mg
n=10 Participants
CLAV 250mg (followed by IV cocaine given 1 hr later) was given either on day 2, day 3 or day 4 according to the protocol
|
CLAV 500mg
n=4 Participants
CLAV 500mg (followed by IV cocaine given 1 hr later) was given either on day 2, day 3 or day 4 according to the protocol
|
Day 5--CLAV 750mg
CLAV 750mg (followed by IV cocaine given 1 hr later) was given on day 5 according to version 2.3 of the protocol.
|
Day 10--Follow up
5-6 days after discharge, subjects returned for a follow up visit to assess adverse events
|
|---|---|---|---|---|---|---|
|
Changes in Blood Pressure in Response to IV Cocaine With and Without CLAV Dosing
SBP at 2 min
|
138.8 mm Hg
Standard Deviation 14.8
|
135.0 mm Hg
Standard Deviation 15.4
|
140.0 mm Hg
Standard Deviation 13.6
|
137.8 mm Hg
Standard Deviation 15.5
|
—
|
—
|
|
Changes in Blood Pressure in Response to IV Cocaine With and Without CLAV Dosing
Max change in SBP
|
21.6 mm Hg
Standard Deviation 13.0
|
23.5 mm Hg
Standard Deviation 11.3
|
18.4 mm Hg
Standard Deviation 8.9
|
20.9 mm Hg
Standard Deviation 16.4
|
—
|
—
|
|
Changes in Blood Pressure in Response to IV Cocaine With and Without CLAV Dosing
DBP at 2 mim
|
88.5 mm Hg
Standard Deviation 4.6
|
88.8 mm Hg
Standard Deviation 11.2
|
89.5 mm Hg
Standard Deviation 7.2
|
87.8 mm Hg
Standard Deviation 10.0
|
—
|
—
|
|
Changes in Blood Pressure in Response to IV Cocaine With and Without CLAV Dosing
Max change in DBP
|
12.1 mm Hg
Standard Deviation 2.7
|
13.3 mm Hg
Standard Deviation 4.1
|
12.6 mm Hg
Standard Deviation 5.1
|
12.7 mm Hg
Standard Deviation 3.9
|
—
|
—
|
PRIMARY outcome
Timeframe: 4 Days (Study Days 2, 3, 4, 5)Population: 10 participants were randomized to receive PBO or CLAV 250mg or 500mg on days 2,3 and 4 followed one hour later by IV infusion of cocaine. Part way through the study, a 5th day was added giving CLAV 750mg 1hr before the cocaine infusion (Protocol V2.3). Five participants were eligible for Day 5 but one had technical issues with the cocaine infusion and did not receive the full cocaine dose, so that subject is excluded from the report of day 5 effects.
ECG was done 15 min after IV cocaine infusion (following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg). The interval between the Q wave and the T wave, corrected (QTc) is reported.
Outcome measures
| Measure |
Day 1 - IV Cocaine Only
n=10 Participants
Subjects received 20mg IV infusion of cocaine and then 40mg IV cocaine at least 2hours 45 minutes after initial infusion
|
Placebo (PBO)
n=10 Participants
PBO (followed by IV cocaine given 1 hour (hr) later) was given either on day 2, day 3 or day 4 according to the protocol
|
CLAV 250mg
n=10 Participants
CLAV 250mg (followed by IV cocaine given 1 hr later) was given either on day 2, day 3 or day 4 according to the protocol
|
CLAV 500mg
n=4 Participants
CLAV 500mg (followed by IV cocaine given 1 hr later) was given either on day 2, day 3 or day 4 according to the protocol
|
Day 5--CLAV 750mg
CLAV 750mg (followed by IV cocaine given 1 hr later) was given on day 5 according to version 2.3 of the protocol.
|
Day 10--Follow up
5-6 days after discharge, subjects returned for a follow up visit to assess adverse events
|
|---|---|---|---|---|---|---|
|
Electrocardiogram (ECG) Following IV Cocaine With and Without CLAV Dosing
|
431.8 ms
Standard Deviation 16.6
|
432.3 ms
Standard Deviation 19.9
|
430.5 ms
Standard Deviation 16.3
|
431.3 ms
Standard Deviation 14.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 Days (Study Days 2, 3, 4)Population: All 10 participants received PBO, CLAV 250mg or 500mg over 3 days in different order according to randomization. One participant is not included in the analysis due to inadequate samples obtained.
Cocaine concentrations are reported at 10 min and 30 minutes after cocaine infusion (70 and 90 minutes after administration of placebo (PBO), CLAV 250mg or CLAV 500mg).
Outcome measures
| Measure |
Day 1 - IV Cocaine Only
n=9 Participants
Subjects received 20mg IV infusion of cocaine and then 40mg IV cocaine at least 2hours 45 minutes after initial infusion
|
Placebo (PBO)
n=9 Participants
PBO (followed by IV cocaine given 1 hour (hr) later) was given either on day 2, day 3 or day 4 according to the protocol
|
CLAV 250mg
n=9 Participants
CLAV 250mg (followed by IV cocaine given 1 hr later) was given either on day 2, day 3 or day 4 according to the protocol
|
CLAV 500mg
n=9 Participants
CLAV 500mg (followed by IV cocaine given 1 hr later) was given either on day 2, day 3 or day 4 according to the protocol
|
Day 5--CLAV 750mg
n=9 Participants
CLAV 750mg (followed by IV cocaine given 1 hr later) was given on day 5 according to version 2.3 of the protocol.
|
Day 10--Follow up
n=9 Participants
5-6 days after discharge, subjects returned for a follow up visit to assess adverse events
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter of Cocaine-concentration
|
0.355 mg/L
Standard Deviation 0.111
|
0.240 mg/L
Standard Deviation 0.068
|
0.372 mg/L
Standard Deviation 0.094
|
0.215 mg/L
Standard Deviation 0.046
|
0.344 mg/L
Standard Deviation 0.086
|
0.209 mg/L
Standard Deviation 0.049
|
SECONDARY outcome
Timeframe: 3 Days (Study Days 2, 3, 4)Population: 10 subjects received 250mg and 500mg (randomized to different days) but samples for one subject was unusable. A second subject vomited 5 min after both the 250mg dose and the 500mg dose and levels were undetectable; this subject was excluded from analysis. This reports results of 8 subjects.
CLAV concentrations were measured 40 min and 70 min after ingestion of CLAV 250 mg or 500 mg. (The 70 min time point is 10 min after the IV cocaine infusion).The 250mg dose and the 500mg dose were given on different days per the randomization protocol: the 250mg dose was given on either day 2 or 3 and the 500mg dose was given on either day 3 or 4. The lowest level of detection of CLAV is 40ng/ml. A non-detectable level is reported as 0.
Outcome measures
| Measure |
Day 1 - IV Cocaine Only
n=8 Participants
Subjects received 20mg IV infusion of cocaine and then 40mg IV cocaine at least 2hours 45 minutes after initial infusion
|
Placebo (PBO)
n=8 Participants
PBO (followed by IV cocaine given 1 hour (hr) later) was given either on day 2, day 3 or day 4 according to the protocol
|
CLAV 250mg
n=8 Participants
CLAV 250mg (followed by IV cocaine given 1 hr later) was given either on day 2, day 3 or day 4 according to the protocol
|
CLAV 500mg
n=8 Participants
CLAV 500mg (followed by IV cocaine given 1 hr later) was given either on day 2, day 3 or day 4 according to the protocol
|
Day 5--CLAV 750mg
CLAV 750mg (followed by IV cocaine given 1 hr later) was given on day 5 according to version 2.3 of the protocol.
|
Day 10--Follow up
5-6 days after discharge, subjects returned for a follow up visit to assess adverse events
|
|---|---|---|---|---|---|---|
|
Clavulanic Acid (CLAV) Concentrations Following CLAV 250mg and CLAV 500mg Doses
|
0.036 mg/L
Interval 0.0 to 4.015
|
0.506 mg/L
Interval 0.0 to 4.0
|
0.394 mg/L
Interval 0.0 to 1.993
|
1.912 mg/L
Interval 0.181 to 3.94
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 days (Day 2, 3, 4)Population: 10 subjects were randomized and received 250mg and 500mg on different days based on their randomization. One subject's samples were unusable. A second subject vomited after each dose (250mg and 500mg), had nondetectable levels and was excluded in the calculation. This analysis is based on 8 subjects.
The CLAV concentration after ingestion of 250mg CLAV minus the CLAV PK level after the 500 mg dose is reported at 40min and 70 min after ingestion
Outcome measures
| Measure |
Day 1 - IV Cocaine Only
n=8 Participants
Subjects received 20mg IV infusion of cocaine and then 40mg IV cocaine at least 2hours 45 minutes after initial infusion
|
Placebo (PBO)
n=8 Participants
PBO (followed by IV cocaine given 1 hour (hr) later) was given either on day 2, day 3 or day 4 according to the protocol
|
CLAV 250mg
CLAV 250mg (followed by IV cocaine given 1 hr later) was given either on day 2, day 3 or day 4 according to the protocol
|
CLAV 500mg
CLAV 500mg (followed by IV cocaine given 1 hr later) was given either on day 2, day 3 or day 4 according to the protocol
|
Day 5--CLAV 750mg
CLAV 750mg (followed by IV cocaine given 1 hr later) was given on day 5 according to version 2.3 of the protocol.
|
Day 10--Follow up
5-6 days after discharge, subjects returned for a follow up visit to assess adverse events
|
|---|---|---|---|---|---|---|
|
Difference in CLAV Concentrations Between the 250mg and 500mg CLAV Doses
|
0.227 mg/L
Interval -2.022 to 1.405
|
0.331 mg/L
Interval -2.944 to 2.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 10 minutes pre-infusion and 10, 15, 30 and 45 min after cocaine infusion on Study Days 2, 3, and 4Population: 10 subjects receiving IV cocaine infusion were randomized to receive either PBO, CLAV 250mg or CLAV 500mg on days 2, 3,and 4 depending on randomization
Pupil Diameter (mm) was measured 10 minutes pre-infusion and 10, 15, 30 and 45 min after cocaine infusion. Cocaine infusion was done 1 hour following ingestion of placebo (day 2), CLAV 250 mg (day3), or CLAV 500 mg (day 4). Results are reported as median pupil diameter (mm) with interquartile range at different time points relative to the cocaine infusion as noted.
Outcome measures
| Measure |
Day 1 - IV Cocaine Only
n=10 Participants
Subjects received 20mg IV infusion of cocaine and then 40mg IV cocaine at least 2hours 45 minutes after initial infusion
|
Placebo (PBO)
n=10 Participants
PBO (followed by IV cocaine given 1 hour (hr) later) was given either on day 2, day 3 or day 4 according to the protocol
|
CLAV 250mg
n=10 Participants
CLAV 250mg (followed by IV cocaine given 1 hr later) was given either on day 2, day 3 or day 4 according to the protocol
|
CLAV 500mg
CLAV 500mg (followed by IV cocaine given 1 hr later) was given either on day 2, day 3 or day 4 according to the protocol
|
Day 5--CLAV 750mg
CLAV 750mg (followed by IV cocaine given 1 hr later) was given on day 5 according to version 2.3 of the protocol.
|
Day 10--Follow up
5-6 days after discharge, subjects returned for a follow up visit to assess adverse events
|
|---|---|---|---|---|---|---|
|
Pupil Pharmacodynamic Effects of Cocaine With Clavulanic Acid
10 min post-infusion
|
3.55 mm
Interval 3.3 to 3.9
|
3.70 mm
Interval 3.5 to 4.5
|
3.90 mm
Interval 3.6 to 4.5
|
—
|
—
|
—
|
|
Pupil Pharmacodynamic Effects of Cocaine With Clavulanic Acid
15 min post-infusion
|
3.55 mm
Interval 3.3 to 3.7
|
3.40 mm
Interval 3.0 to 4.3
|
3.50 mm
Interval 3.2 to 4.1
|
—
|
—
|
—
|
|
Pupil Pharmacodynamic Effects of Cocaine With Clavulanic Acid
30 min post-infusion
|
3.6 mm
Interval 3.2 to 4.1
|
3.30 mm
Interval 2.9 to 4.1
|
3.35 mm
Interval 3.0 to 4.1
|
—
|
—
|
—
|
|
Pupil Pharmacodynamic Effects of Cocaine With Clavulanic Acid
45 min post-infusion
|
3.4 mm
Interval 3.2 to 4.0
|
3.10 mm
Interval 2.8 to 3.6
|
3.10 mm
Interval 2.7 to 3.7
|
—
|
—
|
—
|
|
Pupil Pharmacodynamic Effects of Cocaine With Clavulanic Acid
-10 min pre-infusion
|
3.1 mm
Interval 2.8 to 3.5
|
3.10 mm
Interval 2.7 to 3.4
|
3.20 mm
Interval 2.8 to 3.5
|
—
|
—
|
—
|
Adverse Events
Day 1-IV Cocaine Infusion Only
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo + IV Cocaine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CLAV 250mg + IV Cocaine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CLAV 500mg + IV Cocaine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Day 5--CLAV 750mg + IV Cocaine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Discharge Day
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Day 10-Follow-up
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Day 1-IV Cocaine Infusion Only
n=10 participants at risk
Subjects received IV cocaine 20mg and then at least 2hr 45min later they received IV cocaine 40mg
|
Placebo + IV Cocaine
n=10 participants at risk
Subjects were randomized to receive oral matched placebo (on day 2, 3 or 4) followed by IV cocaine 40mg 1hr later
|
CLAV 250mg + IV Cocaine
n=10 participants at risk
Subjects were randomized to receive oral CLAV 250mg (on day 2, 3 or 4) followed by IV cocaine 40mg 1hr later
|
CLAV 500mg + IV Cocaine
n=10 participants at risk
Subjects were randomized to receive oral CLAV 500mg (on day 2, 3 or 4) followed by IV cocaine 40mg 1hr later
|
Day 5--CLAV 750mg + IV Cocaine
n=5 participants at risk
Protocol V2.3 allowed for subjects to proceed to day 5 receiving 750mg after they completed Day 2,3 and 4 and received PBO, CLAV 250mg and CLAV 500mg iper day n some randomized order
|
Discharge Day
n=10 participants at risk
Day after last dose of study drug (Day 6 for those completing day 5 CLAV 750mg; ot Day 5 for those completing days 1-4 only)
|
Day 10-Follow-up
n=10 participants at risk
All subjects returned for a follow-up visit on Day 10 of the study (5-6 days after discharge)
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
upper respiratory infection (URI)
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/5 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
20.0%
2/10 • Number of events 2 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
|
Cardiac disorders
Ventricular tachycardia
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/5 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
|
Gastrointestinal disorders
Abdominal gas
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/5 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
|
Gastrointestinal disorders
Nausea+vomiting
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/5 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/5 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
|
Gastrointestinal disorders
Indigestion
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/5 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
|
Skin and subcutaneous tissue disorders
Reaction to Telemetry Pads on Skin
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/5 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
|
Skin and subcutaneous tissue disorders
Itchy Skin
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/5 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
|
Eye disorders
Teary eyes
|
10.0%
1/10 • Number of events 2 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/5 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
|
Eye disorders
Lower eyelid twitch rhythmic
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/5 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
|
Metabolism and nutrition disorders
Elevated calcium levels
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/5 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
|
Musculoskeletal and connective tissue disorders
Hand bilateral spasms
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/5 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
|
Nervous system disorders
Lightheaded
|
10.0%
1/10 • Number of events 2 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/5 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
40.0%
2/5 • Number of events 2 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
|
Nervous system disorders
Drowsiness
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/5 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
|
Nervous system disorders
Insomnia
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/5 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
|
Musculoskeletal and connective tissue disorders
Tooth Ache
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/5 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/5 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
10.0%
1/10 • Number of events 1 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
0.00%
0/10 • Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
|
Additional Information
Yaminah Carter Research Coordinator
Temple University Episcopal Hospital
Phone: 2678097602
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The results in this trial are considered proprietary and still under evaluation.
- Publication restrictions are in place
Restriction type: OTHER