Trial Outcomes & Findings for Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia (NCT NCT02086786)
NCT ID: NCT02086786
Last Updated: 2017-07-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.
Results posted on
2017-07-13
Participant Flow
Participant milestones
| Measure |
Gluteus (Risperidone ISM)
Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM
|
Deltoid (Risperdione ISM)
Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
18
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia
Baseline characteristics by cohort
| Measure |
Gluteus (Risperidone ISM)
n=34 Participants
Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM
|
Deltoid (Risperdione ISM)
n=33 Participants
Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
67 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 11.1 • n=93 Participants
|
44 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
43 years
STANDARD_DEVIATION 10.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=93 Participants
|
33 participants
n=4 Participants
|
67 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.Population: The analysis was conducted in the PK population, which includes 43 patients (20 in the gluteal and 23 in the deltoid site injection group) who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis. They also had concentration data amenable to evaluation as determined by the pharmacokineticist.
Outcome measures
| Measure |
Gluteus (Risperidone ISM)
n=20 Participants
Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
Deltoid (Risperdione ISM)
n=23 Participants
Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
|---|---|---|
|
Peak Plasma Concentration (Cmax) for Active Moiety
Dose 1
|
39.6 ng/mL
Geometric Coefficient of Variation 33.7
|
54.1 ng/mL
Geometric Coefficient of Variation 48.9
|
|
Peak Plasma Concentration (Cmax) for Active Moiety
Dose 2
|
53.2 ng/mL
Geometric Coefficient of Variation 52.7
|
61.0 ng/mL
Geometric Coefficient of Variation 38.4
|
|
Peak Plasma Concentration (Cmax) for Active Moiety
Dose 3
|
48.6 ng/mL
Geometric Coefficient of Variation 33.3
|
61.0 ng/mL
Geometric Coefficient of Variation 36.9
|
|
Peak Plasma Concentration (Cmax) for Active Moiety
Dose 4
|
47.4 ng/mL
Geometric Coefficient of Variation 38.9
|
57.7 ng/mL
Geometric Coefficient of Variation 39.3
|
PRIMARY outcome
Timeframe: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.Population: The analysis was conducted in the PK population, which includes 43 patients (20 in the gluteal and 23 in the deltoid site injection group) who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis. They also had concentration data amenable to evaluation as determined by the pharmacokineticist.
Outcome measures
| Measure |
Gluteus (Risperidone ISM)
n=20 Participants
Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
Deltoid (Risperdione ISM)
n=23 Participants
Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
|---|---|---|
|
Trough Plasma Concentration (Cmin) for Active Moiety
Dose 1
|
11.1 ng/mL
Geometric Coefficient of Variation 72.6
|
7.0 ng/mL
Geometric Coefficient of Variation 87.6
|
|
Trough Plasma Concentration (Cmin) for Active Moiety
Dose 2
|
7.86 ng/mL
Geometric Coefficient of Variation 90.1
|
8.60 ng/mL
Geometric Coefficient of Variation 49.4
|
|
Trough Plasma Concentration (Cmin) for Active Moiety
Dose 3
|
9.97 ng/mL
Geometric Coefficient of Variation 70.7
|
10.2 ng/mL
Geometric Coefficient of Variation 57.6
|
|
Trough Plasma Concentration (Cmin) for Active Moiety
Dose 4
|
12.6 ng/mL
Geometric Coefficient of Variation 59.1
|
9.52 ng/mL
Geometric Coefficient of Variation 56.5
|
PRIMARY outcome
Timeframe: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.Population: The analysis was conducted in the PK population (patients who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis). As determined by the pharmacokineticist, for this analysis, 18 patients in the gluteal and 22 in the deltoids had concentration amenable to evaluation..
Outcome measures
| Measure |
Gluteus (Risperidone ISM)
n=18 Participants
Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
Deltoid (Risperdione ISM)
n=22 Participants
Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
|---|---|---|
|
Area Under the Curve to the Last Quantified Concentration (AUClast) for Active Moiety
|
21300 h*ng/mL
Geometric Coefficient of Variation 35.2
|
23300 h*ng/mL
Geometric Coefficient of Variation 43.3
|
PRIMARY outcome
Timeframe: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.Population: The analysis was conducted in the PK population (patients who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis). As determined by the pharmacokineticist, for this analysis, 11 patients in the gluteal and 18 in the deltoids had concentration amenable to evaluation.
Outcome measures
| Measure |
Gluteus (Risperidone ISM)
n=11 Participants
Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
Deltoid (Risperdione ISM)
n=18 Participants
Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
|---|---|---|
|
Area Under the Curve Extrapolated to Infinity (AUC∞) for Active Moiety
|
21100 h*ng/mL
Geometric Coefficient of Variation 27.4
|
22700 h*ng/mL
Geometric Coefficient of Variation 40.4
|
PRIMARY outcome
Timeframe: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.Population: The analysis was conducted in the PK population: 43 patients (20 in the gluteal and 23 in the deltoid site injection group). As determined by the pharmacokineticist, for Dose 4th analysis, 18 patients in the gluteal and 22 in the deltoid group had concentration amenable to evaluation.
AUCτ is the area under the curve over the dosing interval (τ), where the dosing interval is 28 days
Outcome measures
| Measure |
Gluteus (Risperidone ISM)
n=20 Participants
Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
Deltoid (Risperdione ISM)
n=23 Participants
Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
|---|---|---|
|
AUCτ for Active Moiety
Dose 1
|
14100 h*ng/mL
Geometric Coefficient of Variation 39.5
|
16300 h*ng/mL
Geometric Coefficient of Variation 42.6
|
|
AUCτ for Active Moiety
Dose 2
|
15400 h*ng/mL
Geometric Coefficient of Variation 59.3
|
18000 h*ng/mL
Geometric Coefficient of Variation 40.2
|
|
AUCτ for Active Moiety
Dose 3
|
16600 h*ng/mL
Geometric Coefficient of Variation 24.2
|
18200 h*ng/mL
Geometric Coefficient of Variation 32.5
|
|
AUCτ for Active Moiety
Dose 4
|
17300 h*ng/mL
Geometric Coefficient of Variation 27.1
|
18500 h*ng/mL
Geometric Coefficient of Variation 35.9
|
PRIMARY outcome
Timeframe: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.Population: The analysis was conducted in the PK population, which includes 43 patients (20 in the gluteal and 23 in the deltoid site injection group) who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis. They also had concentration data amenable to evaluation as determined by the pharmacokineticist.
Outcome measures
| Measure |
Gluteus (Risperidone ISM)
n=20 Participants
Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
Deltoid (Risperdione ISM)
n=23 Participants
Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
|---|---|---|
|
Time to Peak Concentration (Tmax) for Active Moiety
Dose 1
|
48.0 h
Interval 23.9 to 504.0
|
48.0 h
Interval 23.8 to 216.0
|
|
Time to Peak Concentration (Tmax) for Active Moiety
Dose 2
|
24.0 h
Interval 2.0 to 48.1
|
24.0 h
Interval 2.08 to 479.0
|
|
Time to Peak Concentration (Tmax) for Active Moiety
Dose 3
|
48.0 h
Interval 12.0 to 504.0
|
24.0 h
Interval 2.0 to 215.0
|
|
Time to Peak Concentration (Tmax) for Active Moiety
Dose 4
|
24.0 h
Interval 7.97 to 502.0
|
48.0 h
Interval 2.13 to 505.0
|
PRIMARY outcome
Timeframe: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.Population: The analysis was conducted in the PK population (patients who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis). As determined by the pharmacokineticist, for this analysis, 12 patients in the gluteal and 19 in the deltoid group had concentration amenable to evaluation.
Outcome measures
| Measure |
Gluteus (Risperidone ISM)
n=12 Participants
Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
Deltoid (Risperdione ISM)
n=19 Participants
Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
|---|---|---|
|
Terminal Half-life (t1/2) for Active Moiety
|
163 h
Geometric Coefficient of Variation 80.5
|
269 h
Geometric Coefficient of Variation 71.6
|
PRIMARY outcome
Timeframe: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.Population: The analysis was conduct in the PK population, which includes 43 patients (20 in the gluteal and 23 in the deltoid site injection group) who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis. They also had concentration data amenable to evaluation as determined by the pharmacokineticist.
Peak to Trough Fluctuation ratio for the Active Moiety
Outcome measures
| Measure |
Gluteus (Risperidone ISM)
n=20 Participants
Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
Deltoid (Risperdione ISM)
n=23 Participants
Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
|---|---|---|
|
PTF for Active Moiety
Dose 1
|
0.999 Ratio
Geometric Coefficient of Variation 181.6
|
1.76 Ratio
Geometric Coefficient of Variation 47.6
|
|
PTF for Active Moiety
Dose 2
|
1.89 Ratio
Geometric Coefficient of Variation 38.1
|
1.88 Ratio
Geometric Coefficient of Variation 23.0
|
|
PTF for Active Moiety
Dose 3
|
1.39 Ratio
Geometric Coefficient of Variation 51.9
|
1.82 Ratio
Geometric Coefficient of Variation 29.6
|
SECONDARY outcome
Timeframe: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.Population: The analysis was conducted in the PK population (patients who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis). As determined by the pharmacokineticist, for this analysis, 18 patients in the gluteal and 22 in the deltoid group had concentration amenable to evaluation.
Defined as AUC (0-28 days) after the 4th dose divided by the AUC (0-28 days) of the first dose.
Outcome measures
| Measure |
Gluteus (Risperidone ISM)
n=18 Participants
Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
Deltoid (Risperdione ISM)
n=22 Participants
Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
|---|---|---|
|
Accumulation Ratio (RA) for Active Moiety
|
1.15 Ratio
Geometric Coefficient of Variation 25.1
|
1.14 Ratio
Geometric Coefficient of Variation 26.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Days 5, 7, 10, 14, 18, and 21 post Dose 1; Dose 2, 3 and 4 post dose; Days 5, 7, 10, 14, 18, and 21 post Dose 2, 3, and 4; Days 25, 28, 32, 37, 42, 60, 75, 90, and 105 post Dose 4; Day 120 post Dose 4 or early termination.Population: The analysis was conduct in the Intent-to-Treat (ITT) Population, which includes all patients in Safety Population with baseline (Day -1) efficacy data and at least 1 post-baseline efficacy evaluation. ITT Population includes 66 patients; 33 on each arm.
The change in PANSS score from Baseline by visit 48. The PANSS combines 3 subscales: The positive scale (7 items), the negative scale (7 items) and the general psychopathology scale (16 items). PANSS Items Scores: 1 = Absent, 2 = Minimal, 3 = Mild, 4 = Moderate, 5 = Moderate Severe, 6 = Severe, 7 = Extreme. Subscales are summed to compute a total score Range for each of the subscales: Positive scale (7-49); Negative scale (7-49); General psychopathology scale (16-112) Range for the PANSS total scale: 30-210 PANSS total score ≤70: stable schizophrenia PANSS total score between \>70: decompensated schizophrenia
Outcome measures
| Measure |
Gluteus (Risperidone ISM)
n=33 Participants
Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
Deltoid (Risperdione ISM)
n=33 Participants
Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
|
|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS) Total Score
Baseline (Day -1)
|
58 points
Standard Deviation 10.4
|
60 points
Standard Deviation 9.8
|
|
Positive and Negative Syndrome Scale (PANSS) Total Score
Visit 48 (Day 120 post Dose 4)
|
59 points
Standard Deviation 16.4
|
61 points
Standard Deviation 10.8
|
Adverse Events
Gluteus (Risperidone ISM)
Serious events: 5 serious events
Other events: 32 other events
Deaths: 0 deaths
Deltoid (Risperdione ISM)
Serious events: 7 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gluteus (Risperidone ISM)
n=34 participants at risk
Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM
|
Deltoid (Risperdione ISM)
n=33 participants at risk
Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM
|
|---|---|---|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/34 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/34 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
0.00%
0/33 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
0.00%
0/33 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.00%
0/34 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Nervous system disorders
Oromandibular dystonia
|
0.00%
0/34 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Psychiatric disorders
Anxiety
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
0.00%
0/33 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/34 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Psychiatric disorders
Psychotic disorder
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
0.00%
0/33 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/34 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
9.1%
3/33 • Number of events 3 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Psychiatric disorders
Suicidal ideation
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
0.00%
0/33 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
Other adverse events
| Measure |
Gluteus (Risperidone ISM)
n=34 participants at risk
Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Risperidone ISM
|
Deltoid (Risperdione ISM)
n=33 participants at risk
Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Risperidone ISM
|
|---|---|---|
|
Endocrine disorders
Hyperprolactinaemia
|
55.9%
19/34 • Number of events 55 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
51.5%
17/33 • Number of events 41 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Cardiac disorders
Tachycardi
|
0.00%
0/34 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
6.1%
2/33 • Number of events 3 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/34 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
6.1%
2/33 • Number of events 3 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
General disorders
Fatigue
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
6.1%
2/33 • Number of events 2 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
General disorders
Injection site erythema
|
20.6%
7/34 • Number of events 12 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
9.1%
3/33 • Number of events 6 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
General disorders
Injection site induration
|
2.9%
1/34 • Number of events 2 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
12.1%
4/33 • Number of events 4 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
General disorders
Injection site pain
|
35.3%
12/34 • Number of events 31 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
30.3%
10/33 • Number of events 25 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
General disorders
Pain
|
8.8%
3/34 • Number of events 4 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
6.1%
2/33 • Number of events 2 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/34 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
6.1%
2/33 • Number of events 2 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Investigations
ECG QT prolonged
|
0.00%
0/34 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
6.1%
2/33 • Number of events 3 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Investigations
Heart rate increased
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
6.1%
2/33 • Number of events 2 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Musculoskeletal and connective tissue disorders
Muskuloskeletal stiffness
|
5.9%
2/34 • Number of events 2 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
6.1%
2/33 • Number of events 2 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/34 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
6.1%
2/33 • Number of events 2 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Nervous system disorders
Dizziness
|
11.8%
4/34 • Number of events 4 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
6.1%
2/33 • Number of events 2 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Nervous system disorders
Drooling
|
0.00%
0/34 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
9.1%
3/33 • Number of events 3 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Nervous system disorders
Headache
|
11.8%
4/34 • Number of events 7 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Nervous system disorders
Oromandibular dystonia
|
5.9%
2/34 • Number of events 2 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
21.2%
7/33 • Number of events 8 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Nervous system disorders
Sedation
|
17.6%
6/34 • Number of events 7 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
12.1%
4/33 • Number of events 5 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Nervous system disorders
Somnolence
|
5.9%
2/34 • Number of events 2 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
21.2%
7/33 • Number of events 8 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Psychiatric disorders
Schizophrenia
|
5.9%
2/34 • Number of events 2 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
9.1%
3/33 • Number of events 3 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.8%
3/34 • Number of events 3 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
0.00%
0/33 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
2/34 • Number of events 2 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
6.1%
2/33 • Number of events 2 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Vascular disorders
Hypertension
|
0.00%
0/34 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
6.1%
2/33 • Number of events 2 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
|
Vascular disorders
Hypotension
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
9.1%
3/33 • Number of events 5 • Adverse event data were collected in all visits of the study: Screening, Baseline (Day -1); Day 0 (Dose 1); Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 1; Dose 2, 3 & 4 Prior to Dosage and Post Dose; Days 1, 2, 5, 7, 10, 14, 18 & 21 Post Dose 2, 3 & 4; Days 25, 28, 32, 37, 42, 60, 75, 90 & 105 Post-Dose 4; Day 120 Post-Dose 4 (final visit) or any Early Termination.
The analysis was performed in the Safety Population, which includes all patients who received at least 1 dose of the study drug: 67 patients in total, 34 of them were in the gluteal arm and 33 in the Deltoid arm. This is the population at risk.
|
Additional Information
Jordi Llaudó Garín ( Clinical Development Manager)
Rovi S.A. Laboratorios Farmacéuticos
Phone: +34913756230
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor intends to publish clinical data from all centers participating in the investigation. A draft manuscripts will submit to all participating investigators for their comments. Individual investigators subsequently may publish additional findings of this study in scientific journals/scientific meetings, provided that the sponsor is given ample opportunity to review any proposed abstract, manuscript, or slide presentation prior to its submission.
- Publication restrictions are in place
Restriction type: OTHER