Trial Outcomes & Findings for A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis (NCT NCT02473393)
NCT ID: NCT02473393
Last Updated: 2021-03-24
Results Overview
Judged according to the assessment criteria for the bacterial strain isolated as the causative pathogen based on the data from the microbiological examination. Analysis was performed by disease group and by dose, and by minimum inhibitory concentration (MIC) values of OPS-2071 for each of the causative strains (Enterotoxigenic E. coli, Enteroaggregative E. coli, Campylobacter sp., C. jejuni, S. aureus, K. oxytoca, and C. perfringens for the EI group). Data were shown as all strains total. Concerning microbiological outcome by causative strain, bacteria elimination rate (BER) and its 95% confidence interval (CI) were calculated. The BER was the proportion of causative strains assessed as either "Excellent" or "Good" except for those assessed as "unknown/indeterminate".
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
CDI group: screening, Day 4 and Day 11 (end of treatment), EI group: screening, Day 4 and Day 8 (end of treatment)
Results posted on
2021-03-24
Participant Flow
This trial was performed as a global trial in Japan, Republic of Korea, and Singapore.
Subjects with bacterial enteritis were divided into 2 groups, a Clostridium difficile infection (CDI) group for subjects with bacterial enteritis associated with C. difficile infection and an enteric infection (EI) group for subjects with bacterial enteritis for which the causative pathogen was Salmonella, Campylobacter, or pathogenic E. coli. Only one dosage (100 mg) of OPS-2071 was administered to CDI subjects and 3 dosages (100, 50, and 200 mg) were administered to EI subjects.
Participant milestones
| Measure |
CDI Group
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days.
|
EI Group (50 mg)
OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (100 mg)
OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (200 mg)
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
12
|
13
|
13
|
|
Overall Study
COMPLETED
|
5
|
12
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
CDI Group
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days.
|
EI Group (50 mg)
OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (100 mg)
OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (200 mg)
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis
Baseline characteristics by cohort
| Measure |
CDI Group
n=5 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days.
|
EI Group (50 mg)
n=12 Participants
OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (100 mg)
n=12 Participants
OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (200 mg)
n=12 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
12 Participants
n=157 Participants
|
37 Participants
n=390 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
4 Participants
n=390 Participants
|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 24.52 • n=99 Participants
|
36.0 years
STANDARD_DEVIATION 15.78 • n=107 Participants
|
36.3 years
STANDARD_DEVIATION 16.51 • n=206 Participants
|
35.6 years
STANDARD_DEVIATION 12.41 • n=157 Participants
|
39.4 years
STANDARD_DEVIATION 18.22 • n=390 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
20 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
7 Participants
n=157 Participants
|
21 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
4 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
10 Participants
n=157 Participants
|
36 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Korean
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Singaporean
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Others
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
|
Region of Enrollment
South Korea
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
|
Region of Enrollment
Singapore
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
|
Region of Enrollment
Japan
|
4 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
12 Participants
n=157 Participants
|
38 Participants
n=390 Participants
|
PRIMARY outcome
Timeframe: CDI group: screening, Day 4 and Day 11 (end of treatment), EI group: screening, Day 4 and Day 8 (end of treatment)Population: Microbiological per Protocol Set (MPPS) comprised those subjects in the FAS for whom the causative pathogen was identified and for whom microbiological outcome was assessed as "Excellent", "Good", or "Poor" , excluding subjects for whom microbiological outcome was assessed as "unknown/indeterminate".
Judged according to the assessment criteria for the bacterial strain isolated as the causative pathogen based on the data from the microbiological examination. Analysis was performed by disease group and by dose, and by minimum inhibitory concentration (MIC) values of OPS-2071 for each of the causative strains (Enterotoxigenic E. coli, Enteroaggregative E. coli, Campylobacter sp., C. jejuni, S. aureus, K. oxytoca, and C. perfringens for the EI group). Data were shown as all strains total. Concerning microbiological outcome by causative strain, bacteria elimination rate (BER) and its 95% confidence interval (CI) were calculated. The BER was the proportion of causative strains assessed as either "Excellent" or "Good" except for those assessed as "unknown/indeterminate".
Outcome measures
| Measure |
CDI Group
n=2 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days.
|
EI Group (50 mg)
n=9 Participants
OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (100 mg)
n=9 Participants
OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (200 mg)
n=7 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
|---|---|---|---|---|
|
Bacterial Elimination Rate (BER) in the CDI and EI Groups
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
72.7 percentage of participants
Interval 39.0 to 94.0
|
90.0 percentage of participants
Interval 55.5 to 99.7
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
PRIMARY outcome
Timeframe: Inpatient: 1h, 2h, and 4h after morning administrationPopulation: Pharmacokinetics Analysis Set (PKS) comprised subjects in whom plasma drug concentration had been measured at least once.
We measured OPS-2071 concentration in plasma and evaluated Cmax of OPS-2071 in plasma.
Outcome measures
| Measure |
CDI Group
n=1 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days.
|
EI Group (50 mg)
n=2 Participants
OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (100 mg)
n=2 Participants
OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (200 mg)
n=2 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of OPS-2071 on Day 4
|
64 µg/L
|
29.2 µg/L
Interval 17.7 to 40.6
|
42.4 µg/L
Interval 38.5 to 46.2
|
81.9 µg/L
Interval 62.8 to 101.0
|
PRIMARY outcome
Timeframe: 1h, 2h, and 4h after morning administrationPopulation: Pharmacokinetics Analysis Set (PKS) comprised subjects in whom plasma drug concentration had been measured at least once.
We measured OPS-2071 concentration in plasma and evaluated tmax of OPS-2071 in plasma.
Outcome measures
| Measure |
CDI Group
n=1 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days.
|
EI Group (50 mg)
n=2 Participants
OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (100 mg)
n=2 Participants
OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (200 mg)
n=2 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of OPS-2071 on Day 4
|
4.15 h
Interval 4.15 to 4.15
|
1.98 h
Interval 1.95 to 2.0
|
4.08 h
Interval 4.03 to 4.12
|
2.42 h
Interval 0.92 to 3.92
|
SECONDARY outcome
Timeframe: Day 38Population: Clinical per protocol set (CPPS) comprised those subjects in the FAS for whom all scheduled examinations at all specified observation time points up until end of treatment or withdrawal had been performed. Analysis was performed by dose in the proportion of subjects judged as "clinical cure" at end of treatment (EOT) in the CPPS.
CDI recurrence rate at follow-up (Day 38) or withdrawal was calculated. CDI recurrence rate was the proportion of the subjects judged as "recurrent" against evaluable subjects, except for those with missing data.
Outcome measures
| Measure |
CDI Group
n=4 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days.
|
EI Group (50 mg)
OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (100 mg)
OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (200 mg)
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
|---|---|---|---|---|
|
The Recurrence Rate of CDI After Multiple Doses of OPS-2071 (for CDI Group Only)
|
0.0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: CDI group: Day 4, Day 11 (end of treatment) and Day 38, EI group: Day 4 and Day 8 (end of treatment)Population: CPPS comprised those subjects in the FAS for whom all scheduled examinations at all specified observation time points up until end of treatment or withdrawal had been performed.
The time from the start of dosing until the first formed stool (except in cases where liquid or unformed stools recurred) was evaluated as time to resolution of diarrhea. If formed stool has not been observed, then the subject will be handled as missing data.
Outcome measures
| Measure |
CDI Group
n=3 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days.
|
EI Group (50 mg)
n=10 Participants
OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (100 mg)
n=9 Participants
OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (200 mg)
n=9 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
|---|---|---|---|---|
|
The Time to Resolution of Diarrhea After Multiple Doses of OPS-2071
|
3.7 days
Standard Deviation 1.53
|
4.3 days
Standard Deviation 1.34
|
4.4 days
Standard Deviation 2.01
|
4.6 days
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment)Population: CPPS comprised those subjects in the FAS for whom all scheduled examinations at all specified observation time points up until end of treatment or withdrawal had been performed.
Under each disease group, the improvement of clinical symptoms (stool frequency/day) were assessed.
Outcome measures
| Measure |
CDI Group
n=4 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days.
|
EI Group (50 mg)
n=10 Participants
OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (100 mg)
n=10 Participants
OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (200 mg)
n=12 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
|---|---|---|---|---|
|
Stool Frequency Per Day After Multiple Doses of OPS-2071
Screening
|
5.3 stool frequency/day
Standard Deviation 3.30
|
7.3 stool frequency/day
Standard Deviation 2.91
|
7.1 stool frequency/day
Standard Deviation 2.77
|
9.2 stool frequency/day
Standard Deviation 4.28
|
|
Stool Frequency Per Day After Multiple Doses of OPS-2071
Day 4
|
1.5 stool frequency/day
Standard Deviation 0.58
|
2.9 stool frequency/day
Standard Deviation 1.52
|
1.4 stool frequency/day
Standard Deviation 0.97
|
2.7 stool frequency/day
Standard Deviation 2.74
|
|
Stool Frequency Per Day After Multiple Doses of OPS-2071
Day 8
|
—
|
2.0 stool frequency/day
Standard Deviation 1.41
|
1.7 stool frequency/day
Standard Deviation 0.67
|
2.6 stool frequency/day
Standard Deviation 1.93
|
|
Stool Frequency Per Day After Multiple Doses of OPS-2071
Day 11
|
2.3 stool frequency/day
Standard Deviation 0.96
|
—
|
—
|
—
|
|
Stool Frequency Per Day After Multiple Doses of OPS-2071
Day 38
|
1.3 stool frequency/day
Standard Deviation 0.58
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment)Population: CPPS comprised those subjects in the FAS for whom all scheduled examinations at all specified observation time points up until end of treatment or withdrawal had been performed.
Under each disease group, the improvement of clinical symptoms ((i.e. formed stool, liquid or unformed stool \[3 and more times\], and presence of bloody stool) were assessed.
Outcome measures
| Measure |
CDI Group
n=4 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days.
|
EI Group (50 mg)
n=10 Participants
OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (100 mg)
n=10 Participants
OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (200 mg)
n=12 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
|---|---|---|---|---|
|
Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071
Bloody stool on Day 8
|
—
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071
Bloody stool on Day 11
|
0 participants
|
—
|
—
|
—
|
|
Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071
Bloody stool on Day 38
|
0 participants
|
—
|
—
|
—
|
|
Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071
Liquid or unformed stool on Day 8
|
—
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071
Liquid or unformed stool on Day 11
|
2 participants
|
—
|
—
|
—
|
|
Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071
Liquid or unformed stool on Day 38
|
0 participants
|
—
|
—
|
—
|
|
Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071
Bloody stool at Screening
|
0 participants
|
2 participants
|
3 participants
|
2 participants
|
|
Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071
Bloody stool on Day 4
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071
Formed stool at Screening
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071
Formed stool on Day 4
|
2 participants
|
7 participants
|
3 participants
|
5 participants
|
|
Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071
Formed stool on Day 8
|
—
|
7 participants
|
9 participants
|
8 participants
|
|
Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071
Formed stool on Day 11
|
1 participants
|
—
|
—
|
—
|
|
Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071
Formed stool on Day 38
|
2 participants
|
—
|
—
|
—
|
|
Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071
Liquid or unformed stool at Screening
|
4 participants
|
10 participants
|
10 participants
|
12 participants
|
|
Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071
Liquid or unformed stool on Day 4
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment)Population: CPPS comprised those subjects in the FAS for whom all scheduled examinations at all specified observation time points up until end of treatment or withdrawal had been performed.
Under each disease group, he improvement of clinical symptoms (i.e. presence of abdominal pain, nausea, and vomiting) were assessed.
Outcome measures
| Measure |
CDI Group
n=4 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days.
|
EI Group (50 mg)
n=10 Participants
OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (100 mg)
n=10 Participants
OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (200 mg)
n=12 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
|---|---|---|---|---|
|
Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071
Abdominal pain on Day 8
|
—
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071
Abdominal pain on Day 11
|
0 participants
|
—
|
—
|
—
|
|
Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071
Abdominal pain on Day 38
|
0 participants
|
—
|
—
|
—
|
|
Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071
Nausea at Screening
|
1 participants
|
6 participants
|
7 participants
|
2 participants
|
|
Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071
Nausea on Day 4
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071
Nausea on Day 8
|
—
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071
Nausea on Day 11
|
0 participants
|
—
|
—
|
—
|
|
Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071
Nausea on Day 38
|
0 participants
|
—
|
—
|
—
|
|
Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071
Vomiting at Screening
|
0 participants
|
2 participants
|
3 participants
|
0 participants
|
|
Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071
Vomiting on Day 4
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071
Vomiting on Day 8
|
—
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071
Vomiting on Day 11
|
0 participants
|
—
|
—
|
—
|
|
Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071
Vomiting on Day 38
|
0 participants
|
—
|
—
|
—
|
|
Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071
Abdominal pain at Screening
|
2 participants
|
10 participants
|
10 participants
|
12 participants
|
|
Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071
Abdominal pain on Day 4
|
1 participants
|
4 participants
|
3 participants
|
5 participants
|
SECONDARY outcome
Timeframe: CDI group: Day 4 and Day 11 (end of treatment), EI group: Day 4 and Day 8 (end of treatment)Population: CPPS comprised those subjects in the FAS for whom all scheduled examinations at all specified observation time points up until end of treatment or withdrawal had been performed.
The CRR and 95% CI at each evaluation time point were calculated. The CRR was calculated as the proportion of the subjects judged as "clinical cure" or "clinical improvement" against evaluable subjects, except for those with missing data.
Outcome measures
| Measure |
CDI Group
n=4 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days.
|
EI Group (50 mg)
n=10 Participants
OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (100 mg)
n=10 Participants
OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (200 mg)
n=12 Participants
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
|---|---|---|---|---|
|
Clinical Response Rate (CRR) in the CDI and EI Groups
Day 4
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
100.0 percentage of participants
Interval 73.5 to 100.0
|
|
Clinical Response Rate (CRR) in the CDI and EI Groups
End of treatment
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
90.0 percentage of participants
Interval 55.5 to 99.7
|
100.0 percentage of participants
Interval 73.5 to 100.0
|
Adverse Events
CDI Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
EI Group (50 mg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
EI Group (100 mg)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
EI Group (200 mg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CDI Group
n=5 participants at risk
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days.
|
EI Group (50 mg)
n=12 participants at risk
OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (100 mg)
n=13 participants at risk
OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (200 mg)
n=12 participants at risk
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
7.7%
1/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
Other adverse events
| Measure |
CDI Group
n=5 participants at risk
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days.
|
EI Group (50 mg)
n=12 participants at risk
OPS-2071 was orally administered at a dose of 25 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (100 mg)
n=13 participants at risk
OPS-2071 was orally administered at a dose of 50 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
EI Group (200 mg)
n=12 participants at risk
OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 7 days.
The administration was started with the 100 mg group, and the safety and efficacy during the treatment period were to be assessed by the Data Review Committee. If the 100 mg group had no safety concerns and the efficacy was assessed "effective," 10 subjects each who were not in the 100 mg group were to be randomized to the 200 mg or 50 mg group, and the 2 groups were to be treated in parallel. If the 100 mg group had no safety concerns and the efficacy was assessed "not effective," 10 subjects who were not in the 100 mg group were to be allocated to the 200 mg group as the next step.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
1/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
7.7%
1/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
8.3%
1/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Cardiac disorders
Cardiac failure
|
20.0%
1/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
8.3%
1/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
8.3%
1/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
General disorders
Malaise
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
8.3%
1/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
7.7%
1/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
7.7%
1/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
7.7%
1/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Infections and infestations
Pneumonia
|
20.0%
1/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
16.7%
2/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
8.3%
1/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
8.3%
1/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
7.7%
1/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.0%
1/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
7.7%
1/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
8.3%
1/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
1/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
20.0%
1/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
7.7%
1/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
8.3%
1/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
8.3%
1/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
15.4%
2/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
8.3%
1/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
7.7%
1/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
8.3%
1/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
8.3%
1/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
8.3%
1/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
7.7%
1/13 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
0.00%
0/12 • From the start day of IMP administration up to Day 38
Adverse events (AEs) occurring after IMP administration were included in assessment of AEs. All subjects receiving at least 1 dose of IMP were included in the safety set.
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., LTD.
Phone: +81-3-6361-7366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place