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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-152937 | Other Identifier | Japic |
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To assess safety, efficacy and pharmacokinetics of multiple dosesin patients with Bacterial Enteritis caused by Clostridium difficile infection(CDI) or Enteric infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPS-2071 50mg/day | Experimental | OPS-2071 50 mg/day：25 mg tablet administered orally twice daily |
|
| OPS-2071 100 mg/day | Experimental | OPS-2071 100 mg/day：50 mg tablet administered orally twice daily |
|
| OPS-2071 200 mg/day | Experimental | OPS-2071 200 mg/day：100 mg tablet administered orally twice daily |
|
| OPS-2071 400 mg/day | Experimental | OPS-2071 400 mg/day：100 mg two tablets administered orally twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPS-2071 tablet | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial Elimination Rate (BER) in the CDI and EI Groups | 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". | CDI group: screening, Day 4 and Day 11 (end of treatment), EI group: screening, Day 4 and Day 8 (end of treatment) |
| Maximum Plasma Concentration (Cmax) of OPS-2071 on Day 4 | We measured OPS-2071 concentration in plasma and evaluated Cmax of OPS-2071 in plasma. | Inpatient: 1h, 2h, and 4h after morning administration |
| Time to Maximum Plasma Concentration (Tmax) of OPS-2071 on Day 4 | We measured OPS-2071 concentration in plasma and evaluated tmax of OPS-2071 in plasma. | 1h, 2h, and 4h after morning administration |
| Measure | Description | Time Frame |
|---|---|---|
| The Recurrence Rate of CDI After Multiple Doses of OPS-2071 (for CDI Group Only) | 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. | Day 38 |
| The Time to Resolution of Diarrhea After Multiple Doses of OPS-2071 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshitaka Kotobuki | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanto, Region | Japan | |||||
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.
This trial was performed as a global trial in Japan, Republic of Korea, and Singapore.
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| ID | Title | Description |
|---|---|---|
| FG000 | CDI Group | OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set (FAS): all subjects who had received the investigational medicinal product (IMP) at least once and from whom data on at least one efficacy endpoint had been obtained after the start of IMP administration.
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| ID | Title | Description |
|---|---|---|
| BG000 | CDI Group | OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bacterial Elimination Rate (BER) in the CDI and EI Groups | 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". | 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". | Posted | Number | 95% Confidence Interval | percentage of participants | CDI group: screening, Day 4 and Day 11 (end of treatment), EI group: screening, Day 4 and Day 8 (end of treatment) |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CDI Group | OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 15, 2016 | Feb 8, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2017 | Feb 8, 2021 | SAP_001.pdf |
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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. |
| CDI group: Day 4, Day 11 (end of treatment) and Day 38, EI group: Day 4 and Day 8 (end of treatment) |
| Stool Frequency Per Day After Multiple Doses of OPS-2071 | Under each disease group, the improvement of clinical symptoms (stool frequency/day) were assessed. | CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment) |
| Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | 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. | CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment) |
| Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Under each disease group, he improvement of clinical symptoms (i.e. presence of abdominal pain, nausea, and vomiting) were assessed. | CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment) |
| Clinical Response Rate (CRR) in the CDI and EI Groups | 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. | CDI group: Day 4 and Day 11 (end of treatment), EI group: Day 4 and Day 8 (end of treatment) |
| Singapore |
| Singapore |
| Seoul | South Korea |
| Withdrawal by Subject |
|
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | CDI Group | OPS-2071 was orally administered at a dose of 100 mg twice daily in the morning and evening for 10 days. |
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| Primary | Maximum Plasma Concentration (Cmax) of OPS-2071 on Day 4 | We measured OPS-2071 concentration in plasma and evaluated Cmax of OPS-2071 in plasma. | Pharmacokinetics Analysis Set (PKS) comprised subjects in whom plasma drug concentration had been measured at least once. | Posted | Mean | Full Range | µg/L | Inpatient: 1h, 2h, and 4h after morning administration |
|
|
|
| Primary | Time to Maximum Plasma Concentration (Tmax) of OPS-2071 on Day 4 | We measured OPS-2071 concentration in plasma and evaluated tmax of OPS-2071 in plasma. | Pharmacokinetics Analysis Set (PKS) comprised subjects in whom plasma drug concentration had been measured at least once. | Posted | Mean | Full Range | h | 1h, 2h, and 4h after morning administration |
|
|
|
| Secondary | The Recurrence Rate of CDI After Multiple Doses of OPS-2071 (for CDI Group Only) | 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. | 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. | Posted | Number | percentage of participants | Day 38 |
|
|
|
| Secondary | The Time to Resolution of Diarrhea After Multiple Doses of OPS-2071 | 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. | 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. | Posted | Mean | Standard Deviation | days | CDI group: Day 4, Day 11 (end of treatment) and Day 38, EI group: Day 4 and Day 8 (end of treatment) |
|
|
|
| Secondary | Stool Frequency Per Day After Multiple Doses of OPS-2071 | Under each disease group, the improvement of clinical symptoms (stool frequency/day) were assessed. | 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. | Posted | Mean | Standard Deviation | stool frequency/day | CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment) |
|
|
|
| Secondary | Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071 | 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. | 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. | Posted | Number | participants | CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment) |
|
|
|
| Secondary | Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071 | Under each disease group, he improvement of clinical symptoms (i.e. presence of abdominal pain, nausea, and vomiting) were assessed. | 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. | Posted | Number | participants | CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment) |
|
|
|
| Secondary | Clinical Response Rate (CRR) in the CDI and EI Groups | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | CDI group: Day 4 and Day 11 (end of treatment), EI group: Day 4 and Day 8 (end of treatment) |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 3 |
| 5 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 4 | 12 |
| EG002 | 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. | 0 | 13 | 1 | 13 | 8 | 13 |
| EG003 | 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. | 0 | 12 | 0 | 12 | 4 | 12 |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Intercostal neuralgia | Nervous system disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
Not provided
Not provided
|
| Day 4 |
|
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| Day 8 |
|
|
| Day 11 |
|
|
| Day 38 |
|
|
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| Formed stool on Day 4 |
|
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| Formed stool on Day 8 |
|
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| Formed stool on Day 11 |
|
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| Formed stool on Day 38 |
|
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| Liquid or unformed stool at Screening |
|
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| Liquid or unformed stool on Day 4 |
|
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| Liquid or unformed stool on Day 8 |
|
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| Liquid or unformed stool on Day 11 |
|
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| Liquid or unformed stool on Day 38 |
|
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| Bloody stool at Screening |
|
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| Bloody stool on Day 4 |
|
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| Bloody stool on Day 8 |
|
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| Bloody stool on Day 11 |
|
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| Bloody stool on Day 38 |
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|
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| Abdominal pain on Day 4 |
|
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| Abdominal pain on Day 8 |
|
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| Abdominal pain on Day 11 |
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| Abdominal pain on Day 38 |
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| Nausea at Screening |
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| Nausea on Day 4 |
|
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| Nausea on Day 8 |
|
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| Nausea on Day 11 |
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| Nausea on Day 38 |
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| Vomiting at Screening |
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| Vomiting on Day 4 |
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| Vomiting on Day 8 |
|
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| Vomiting on Day 11 |
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| Vomiting on Day 38 |
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| End of treatment |
|