Trial Outcomes & Findings for Intramuscular Dose-Escalation Study With ETI-204 in Adult Volunteers (NCT NCT01932437)
NCT ID: NCT01932437
Last Updated: 2019-05-06
Results Overview
Safety was assessed for all subjects in the Safety Population by collecting and monitoring vital signs, clinical laboratory tests, ECGs, physical examinations, injection site assessments, skin assessments for presence/absence of rash, and adverse events (AEs).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Up to 71 (+/- 4) days or for 30 additional days after the final study visit for subjects with ongoing adverse events at the final scheduled study visit, for each group.
Results posted on
2019-05-06
Participant Flow
Study started July 26, 2013. Study completed July 03, 2014. Conducted at a Phase 1 Clinical Research Unit
Participant milestones
| Measure |
Placebo
Participants received a single intravenous dose of placebo on day 1 followed by a 71 day follow-up.
|
ETI-204 4 mg/kg
Participants received a single intravenous dose of ETI-204 4 mg/kg on day 1with a 71-day follow-up period.
|
ETI-204 8 mg/kg
Participants received a single intravenous dose of ETI-204 8 mg/kg on day 1 with a 71 day follow-up period.
|
ETI-204 16 mg/kg
Participant received a single intravenous dose of ETI-204 16 mg/kg on day 1 with a 71 day follow-up period.
|
ETI-204 20 mg/kg
Participants received a single intravenous dose of ETI-204 20 mg/kg on day 1 with a 71 day follow-up period.
|
ETI-204 24 mg/kg
Participants received a single intravenous dose of ETI-204 24 mg/kg on day 1 with a 71 day follow-up period.
|
|---|---|---|---|---|---|---|
|
Cohort 1 - ETI-204 4 mg/kg or Placebo
STARTED
|
1
|
3
|
0
|
0
|
0
|
0
|
|
Cohort 1 - ETI-204 4 mg/kg or Placebo
COMPLETED
|
1
|
3
|
0
|
0
|
0
|
0
|
|
Cohort 1 - ETI-204 4 mg/kg or Placebo
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 2 - ETI-204 8 mg/kg or Placebo
STARTED
|
2
|
0
|
6
|
0
|
0
|
0
|
|
Cohort 2 - ETI-204 8 mg/kg or Placebo
COMPLETED
|
2
|
0
|
6
|
0
|
0
|
0
|
|
Cohort 2 - ETI-204 8 mg/kg or Placebo
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 3 - ETI-204 16 mg/kg or Placebo
STARTED
|
2
|
0
|
0
|
6
|
0
|
0
|
|
Cohort 3 - ETI-204 16 mg/kg or Placebo
COMPLETED
|
2
|
0
|
0
|
6
|
0
|
0
|
|
Cohort 3 - ETI-204 16 mg/kg or Placebo
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 4 - ETI-204 20 mg/kg or Placebo
STARTED
|
2
|
0
|
0
|
0
|
6
|
0
|
|
Cohort 4 - ETI-204 20 mg/kg or Placebo
COMPLETED
|
2
|
0
|
0
|
0
|
6
|
0
|
|
Cohort 4 - ETI-204 20 mg/kg or Placebo
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 5 - ETI-204 24 mg/kg or Placebo
STARTED
|
2
|
0
|
0
|
0
|
0
|
6
|
|
Cohort 5 - ETI-204 24 mg/kg or Placebo
COMPLETED
|
2
|
0
|
0
|
0
|
0
|
5
|
|
Cohort 5 - ETI-204 24 mg/kg or Placebo
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants received a single intravenous dose of placebo on day 1 followed by a 71 day follow-up.
|
ETI-204 4 mg/kg
Participants received a single intravenous dose of ETI-204 4 mg/kg on day 1with a 71-day follow-up period.
|
ETI-204 8 mg/kg
Participants received a single intravenous dose of ETI-204 8 mg/kg on day 1 with a 71 day follow-up period.
|
ETI-204 16 mg/kg
Participant received a single intravenous dose of ETI-204 16 mg/kg on day 1 with a 71 day follow-up period.
|
ETI-204 20 mg/kg
Participants received a single intravenous dose of ETI-204 20 mg/kg on day 1 with a 71 day follow-up period.
|
ETI-204 24 mg/kg
Participants received a single intravenous dose of ETI-204 24 mg/kg on day 1 with a 71 day follow-up period.
|
|---|---|---|---|---|---|---|
|
Cohort 5 - ETI-204 24 mg/kg or Placebo
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Intramuscular Dose-Escalation Study With ETI-204 in Adult Volunteers
Baseline characteristics by cohort
| Measure |
Placebo
n=9 Participants
IM
Placebo: Placebo comparator
|
ETI-204
n=27 Participants
IM
ETI-204: monoclonal antibody
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 11.53 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 14.31 • n=7 Participants
|
47.0 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Body weight
|
67.71 kg
STANDARD_DEVIATION 13.406 • n=5 Participants
|
76.33 kg
STANDARD_DEVIATION 12.351 • n=7 Participants
|
74.2 kg
STANDARD_DEVIATION 12.989 • n=5 Participants
|
|
Height
|
164.18 cm
STANDARD_DEVIATION 8.859 • n=5 Participants
|
171.01 cm
STANDARD_DEVIATION 8.062 • n=7 Participants
|
169.3 cm
STANDARD_DEVIATION 8.672 • n=5 Participants
|
|
BMI
|
24.92 kg/m2
STANDARD_DEVIATION 2.983 • n=5 Participants
|
26.04 kg/m2
STANDARD_DEVIATION 3.454 • n=7 Participants
|
25.76 kg/m2
STANDARD_DEVIATION 3.337 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 71 (+/- 4) days or for 30 additional days after the final study visit for subjects with ongoing adverse events at the final scheduled study visit, for each group.Population: All subjects who received either ETI-204 or placebo were included in the Safety Population. Placebo subject were included in each cohort (one in Cohort 1 and two each in Cohorts 2, 3 ,4 and 5). Safety data are summarized separately for subjects who received ETI-204 in each dose group and for the pooled placebo group.
Safety was assessed for all subjects in the Safety Population by collecting and monitoring vital signs, clinical laboratory tests, ECGs, physical examinations, injection site assessments, skin assessments for presence/absence of rash, and adverse events (AEs).
Outcome measures
| Measure |
Placebo
n=9 Participants
ETI-204 placebo IM
|
Cohort 1
n=3 Participants
4 mg/kg ETI-204 IM
|
Cohort 2
n=6 Participants
8 mg/kg ETI-204 IM
|
Cohort 3
n=6 Participants
16 mg/kg ETI-204 IM
|
Cohort 4
n=6 Participants
20 mg/kg ETI-204 IM
|
Cohort 5
n=6 Participants
24 mg/kg ETI-203 IM
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Adverse Events
|
5 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.Population: The Pharmacokinetic (PK) Population consisted of all subjects who received ETI-204 IM and had at least one valid PK parameter. One subject in Cohort 2 was excluded from the PK Population because the dosing record was missing.
Blood samples were obtained and serum concentrations were determined for free ETI-204 using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.
Outcome measures
| Measure |
Placebo
n=3 Participants
ETI-204 placebo IM
|
Cohort 1
n=5 Participants
4 mg/kg ETI-204 IM
|
Cohort 2
n=6 Participants
8 mg/kg ETI-204 IM
|
Cohort 3
n=6 Participants
16 mg/kg ETI-204 IM
|
Cohort 4
n=6 Participants
20 mg/kg ETI-204 IM
|
Cohort 5
24 mg/kg ETI-203 IM
|
|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration of ETI-204 (Cmax)
|
24.9 µg/mL
Standard Deviation 4.70
|
54.8 µg/mL
Standard Deviation 6.45
|
105 µg/mL
Standard Deviation 22.5
|
118 µg/mL
Standard Deviation 28.2
|
154 µg/mL
Standard Deviation 32.4
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.Population: The PK Population consisted of all subjects who received ETI-204 IM and had at least one valid PK parameter. One subject in Cohort 2 was excluded from the PK Population because the dosing record was missing.
Blood samples were obtained and serum concentrations were determined for free ETI-204 using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.
Outcome measures
| Measure |
Placebo
n=3 Participants
ETI-204 placebo IM
|
Cohort 1
n=5 Participants
4 mg/kg ETI-204 IM
|
Cohort 2
n=6 Participants
8 mg/kg ETI-204 IM
|
Cohort 3
n=6 Participants
16 mg/kg ETI-204 IM
|
Cohort 4
n=6 Participants
20 mg/kg ETI-204 IM
|
Cohort 5
24 mg/kg ETI-203 IM
|
|---|---|---|---|---|---|---|
|
Time to Maximum Observed Plasma Concentration of ETI-204 (Tmax)
|
9.00 days
Interval 3.0 to 9.0
|
9.00 days
Interval 3.0 to 9.0
|
6.00 days
Interval 6.0 to 14.0
|
6.00 days
Interval 6.0 to 14.0
|
6.00 days
Interval 3.0 to 9.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.Population: The PK Population consisted of all subjects who received ETI-204 IM and had at least one valid PK parameter. One subject in Cohort 2 was excluded from the PK population because the dosing record was missing.
Blood samples were obtained and serum concentrations were determined for free ETI-204 using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.
Outcome measures
| Measure |
Placebo
n=3 Participants
ETI-204 placebo IM
|
Cohort 1
n=5 Participants
4 mg/kg ETI-204 IM
|
Cohort 2
n=6 Participants
8 mg/kg ETI-204 IM
|
Cohort 3
n=6 Participants
16 mg/kg ETI-204 IM
|
Cohort 4
n=6 Participants
20 mg/kg ETI-204 IM
|
Cohort 5
24 mg/kg ETI-203 IM
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last)
|
774 µg.day/mL
Standard Deviation 92.3
|
1540 µg.day/mL
Standard Deviation 328
|
2890 µg.day/mL
Standard Deviation 578
|
3660 µg.day/mL
Standard Deviation 945
|
3740 µg.day/mL
Standard Deviation 570
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.Population: The PK Population consisted of all subjects who received ETI-204 IM and had at least one valid PK parameter. 1 subject in Cohort 2 was excluded because the dosing record was missing. For 4 subjects (1 in Cohort 2, 1 in Cohort 4. and 2 in Cohort 5) the extrapolated portion of AUC0-inf was \>20%; therefore, AUC0-inf was not recorded.
Blood samples were obtained and serum concentrations were determined for free ETI-204 using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.
Outcome measures
| Measure |
Placebo
n=3 Participants
ETI-204 placebo IM
|
Cohort 1
n=4 Participants
4 mg/kg ETI-204 IM
|
Cohort 2
n=6 Participants
8 mg/kg ETI-204 IM
|
Cohort 3
n=5 Participants
16 mg/kg ETI-204 IM
|
Cohort 4
n=4 Participants
20 mg/kg ETI-204 IM
|
Cohort 5
24 mg/kg ETI-203 IM
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf)
|
819 µg.day/mL
Standard Deviation 85.9
|
1580 µg.day/mL
Standard Deviation 441
|
3200 µg.day/mL
Standard Deviation 755
|
4220 µg.day/mL
Standard Deviation 1360
|
3960 µg.day/mL
Standard Deviation 823
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.Population: The PK Population consisted of all subjects who received ETI-204 IM and had at least one valid PK parameter. One subject in Cohort 2 was excluded from the PK Population because the dosing record was missing.
Blood samples were obtained and serum concentrations were determined for free ETI-204 using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.
Outcome measures
| Measure |
Placebo
n=3 Participants
ETI-204 placebo IM
|
Cohort 1
n=5 Participants
4 mg/kg ETI-204 IM
|
Cohort 2
n=6 Participants
8 mg/kg ETI-204 IM
|
Cohort 3
n=6 Participants
16 mg/kg ETI-204 IM
|
Cohort 4
n=6 Participants
20 mg/kg ETI-204 IM
|
Cohort 5
24 mg/kg ETI-203 IM
|
|---|---|---|---|---|---|---|
|
Half-life (t1/2)
|
16.0 days
Standard Deviation 1.60
|
20.2 days
Standard Deviation 8.47
|
19.6 days
Standard Deviation 4.10
|
23.3 days
Standard Deviation 6.17
|
20.0 days
Standard Deviation 7.20
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.Population: The PK Population consisted of all subjects who received ETI-204 IM and had at least one valid PK parameter.1 subject in Cohort 2 was excluded because the dosing record was missing. For 4 subjects (1 in Cohort 2, 1 in Cohort 4, and 2 in Cohort 5) the extrapolated portion of AUC0-inf was \>20%; therefore, AUC0-inf-based parameters were not recorded.
Blood samples were obtained and serum concentrations were determined for free ETI-204 using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.
Outcome measures
| Measure |
Placebo
n=3 Participants
ETI-204 placebo IM
|
Cohort 1
n=4 Participants
4 mg/kg ETI-204 IM
|
Cohort 2
n=6 Participants
8 mg/kg ETI-204 IM
|
Cohort 3
n=5 Participants
16 mg/kg ETI-204 IM
|
Cohort 4
n=4 Participants
20 mg/kg ETI-204 IM
|
Cohort 5
24 mg/kg ETI-203 IM
|
|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F)
|
0.410 Liters/day
Standard Deviation 0.0545
|
0.415 Liters/day
Standard Deviation 0.117
|
0.445 Liters/day
Standard Deviation 0.113
|
0.382 Liters/day
Standard Deviation 0.0736
|
0.478 Liters/day
Standard Deviation 0.202
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and on Days 10, 43, and 71 after the IM injection of ETI-204 or placebo on Day 1.Population: All subjects in the Safety Population who received either ETI-204 IM or placebo.
Blood samples were collected and serum samples were assayed at an initial dilution of 1:10. Samples that were positive at the 1:10 dilution were serially diluted 1:2 and assayed until a negative result was attained. The titer of the most dilute sample yielding a positive result was recorded as the titer for that time point. Immunogenicity was measured by the number of participants in each study arm with anti-ETI-204 antibody values at Days 8, 43 or 71 ≥ 4-times higher than at baseline, or if the titer was negative at baseline, the post-treatment sample(s) required a titer of at least 1:20 for it to be considered positive.
Outcome measures
| Measure |
Placebo
n=9 Participants
ETI-204 placebo IM
|
Cohort 1
n=3 Participants
4 mg/kg ETI-204 IM
|
Cohort 2
n=6 Participants
8 mg/kg ETI-204 IM
|
Cohort 3
n=6 Participants
16 mg/kg ETI-204 IM
|
Cohort 4
n=6 Participants
20 mg/kg ETI-204 IM
|
Cohort 5
n=6 Participants
24 mg/kg ETI-203 IM
|
|---|---|---|---|---|---|---|
|
Number of Participants With Anti-ETI-204 Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=9 participants at risk
ETI-204 Placebo IM
|
Cohort 1
n=3 participants at risk
4 mg/kg ETI-204 IM
|
Cohort 2
n=6 participants at risk
8 mg ETI-204 IM
|
Cohort 3
n=6 participants at risk
16 mg/kg ETI-204 IM
|
Cohort 4
n=6 participants at risk
20 mg/kg ETI-204 IM
|
Cohort 5
n=6 participants at risk
24 mg/kg ETI-204 IM
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
16.7%
1/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
16.7%
1/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
General disorders
Injection site pain
|
22.2%
2/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
33.3%
1/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
16.7%
1/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
16.7%
1/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
16.7%
1/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
16.7%
1/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
16.7%
1/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
16.7%
1/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
16.7%
1/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
16.7%
1/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
Gastrointestinal disorders
Lip Blister
|
0.00%
0/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
16.7%
1/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
Reproductive system and breast disorders
Menstruation Irregular
|
0.00%
0/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
33.3%
1/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
16.7%
1/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
33.3%
1/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
Injury, poisoning and procedural complications
Procedural Dizziness
|
0.00%
0/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
16.7%
1/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
33.3%
1/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
33.3%
1/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
33.3%
1/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
16.7%
1/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic Pregnancy
|
11.1%
1/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
|
Gastrointestinal disorders
Toothache
|
11.1%
1/9 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/3 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
0.00%
0/6 • Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.
Monitoring of Vital signs, clinical laboratory values, ECGs, physical examinations, and adverse events at each scheduled study visit. Skin assessment for presence or absence of rash was performed predose and 1, 2, 4, 12, 24, 48, and 72 hours after the IM injection on Day 1. A Visual Analog Scale for self-evaluation of pain was administered within 0-5 minutes after the IM injection on Day 1 and 2, 4, 8, 24, 48 and 72 hours after the injection.
|
Additional Information
Senior Director of Regulatory
Elusys Therapeutics, Inc.
Phone: 973-808-0222
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The data generated in this clinical study are the exclusive property of the Sponsor. Written approval from the Sponsor is required prior to disclosing any information related to this clinical study.
- Publication restrictions are in place
Restriction type: OTHER