Trial Outcomes & Findings for Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001) (NCT NCT01475370)
NCT ID: NCT01475370
Last Updated: 2021-03-02
Results Overview
Bone marrow samples were taken by bone marrow aspiration, and the percentage of bone marrow blasts was calculated. The result was assessed according to the International Working Group Response Evaluation Criteria where a case was designated as relapse if any of the following occurred: reappearance of leukemic blasts in the peripheral blood or ≥ 5% blasts in the bone marrow after complete response (morphologic relapse).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Treatment period (from the first IMP administration until the time of discontinuation)
Results posted on
2021-03-02
Participant Flow
This trial was an extension trial from the preceding Trial 311-10-001. Subjects who had undergone the observations, examinations, and evaluations which were stipulated for Trial 311-10-001 and who met all the inclusion criteria and did not fall under any of the exclusion criteria for this trial were selected for this trial.
Participant milestones
| Measure |
OCV-501 0.3mg
OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 0.3 mg).
|
OCV-501 1 mg
OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 1 mg).
|
OCV-501 3 mg
OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 3 mg).
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
Reasons for withdrawal
| Measure |
OCV-501 0.3mg
OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 0.3 mg).
|
OCV-501 1 mg
OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 1 mg).
|
OCV-501 3 mg
OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 3 mg).
|
|---|---|---|---|
|
Overall Study
Exacerbation of primary disease
|
2
|
2
|
2
|
|
Overall Study
Study drug administration difficult
|
0
|
1
|
1
|
|
Overall Study
Other than specified
|
1
|
0
|
0
|
Baseline Characteristics
Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)
Baseline characteristics by cohort
| Measure |
OCV-501 0.3mg
n=3 Participants
OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 0.3 mg).
|
OCV-501 1 mg
n=3 Participants
OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 1 mg).
|
OCV-501 3 mg
n=3 Participants
OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 3 mg).
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Treatment period (from the first IMP administration until the time of discontinuation)Bone marrow samples were taken by bone marrow aspiration, and the percentage of bone marrow blasts was calculated. The result was assessed according to the International Working Group Response Evaluation Criteria where a case was designated as relapse if any of the following occurred: reappearance of leukemic blasts in the peripheral blood or ≥ 5% blasts in the bone marrow after complete response (morphologic relapse).
Outcome measures
| Measure |
OCV-501 0.3mg
n=3 Participants
OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 0.3 mg).
|
OCV-501 1 mg
n=3 Participants
OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 1 mg).
|
OCV-501 3 mg
n=3 Participants
OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 3 mg).
|
|---|---|---|---|
|
Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria
|
2 participants
|
2 participants
|
2 participants
|
Adverse Events
OCV-501 0.3mg
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
OCV-501 1 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
OCV-501 3 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OCV-501 0.3mg
n=3 participants at risk
OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 0.3 mg).
|
OCV-501 1 mg
n=3 participants at risk
OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 1 mg).
|
OCV-501 3 mg
n=3 participants at risk
OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 3 mg).
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
66.7%
2/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
66.7%
2/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
Other adverse events
| Measure |
OCV-501 0.3mg
n=3 participants at risk
OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 0.3 mg).
|
OCV-501 1 mg
n=3 participants at risk
OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 1 mg).
|
OCV-501 3 mg
n=3 participants at risk
OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 3 mg).
|
|---|---|---|---|
|
Congenital, familial and genetic disorders
Ichthyosis
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Ear and labyrinth disorders
Ear pruritus
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Ear and labyrinth disorders
Vertigo positional
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Eye disorders
Conjunctival haemorrhage
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Eye disorders
Glaucoma
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Eye disorders
Hypermetropia
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Gastrointestinal disorders
Dental caries
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
General disorders
Injection site reaction
|
66.7%
2/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
66.7%
2/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
100.0%
3/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
General disorders
Injection site induration
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
66.7%
2/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
General disorders
Injection site erythema
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
66.7%
2/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
General disorders
Injection site discolouration
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
General disorders
Administration site reaction
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
General disorders
Injection site anaesthesia
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
General disorders
Injection site mass
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
General disorders
Injection site pain
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
General disorders
Injection site pruritus
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
General disorders
Injection site swelling
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Infections and infestations
Abscess
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Infections and infestations
Cystitis
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Infections and infestations
Gastroenteritis
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Infections and infestations
Localised infection
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Injury, poisoning and procedural complications
Head injury
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
66.7%
2/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Nervous system disorders
Sciatica
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
33.3%
1/3 • Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
|
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