Trial Outcomes & Findings for A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer (NCT NCT01801930)
NCT ID: NCT01801930
Last Updated: 2021-02-26
Results Overview
\[Definition of DLT\] Any of the following adverse events (AEs) that occurred by Day 29 of Cycle 1 and for which a causal relationship to OCV-C02 could not be ruled out: * Grade 3 or higher non-hematological toxicities (except for injection site reaction and laboratory abnormalities lasting \< 7 days without clinical symptoms) * The following hematological toxicities: Grade 4 or higher anemia, Grade 4 or higher neutropenia or lymphocytopenia lasting 7 days, Grade 3 or higher febrile neutropenia, Grade 4 or higher platelet count decreased. The severity of AEs was graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Japanese version). In addition, a DLT-equivalent treatment-emergent adverse event (TEAE) was defined as a DLT occurred during the extend treatment period (at Cycle 2 and thereafter).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Day 29
Results posted on
2021-02-26
Participant Flow
Participant milestones
| Measure |
Dose Level 1
OCV-103 and OCV-104 (0.3 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 2
OCV-103 and OCV-104 (1 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 3
OCV-103 and OCV-104 (3 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 4
OCV-103 and OCV-104 (6 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
6
|
6
|
Reasons for withdrawal
| Measure |
Dose Level 1
OCV-103 and OCV-104 (0.3 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 2
OCV-103 and OCV-104 (1 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 3
OCV-103 and OCV-104 (3 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 4
OCV-103 and OCV-104 (6 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
|---|---|---|---|---|
|
Overall Study
Clear progression of the primary disease is observed
|
6
|
5
|
6
|
6
|
|
Overall Study
DLT occurs
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=6 Participants
OCV-103 and OCV-104 (0.3 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 2
n=6 Participants
OCV-103 and OCV-104 (1 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 3
n=6 Participants
OCV-103 and OCV-104 (3 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 4
n=6 Participants
OCV-103 and OCV-104 (6 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Total
n=24 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
65.8 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
60.7 years
STANDARD_DEVIATION 10.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 29\[Definition of DLT\] Any of the following adverse events (AEs) that occurred by Day 29 of Cycle 1 and for which a causal relationship to OCV-C02 could not be ruled out: * Grade 3 or higher non-hematological toxicities (except for injection site reaction and laboratory abnormalities lasting \< 7 days without clinical symptoms) * The following hematological toxicities: Grade 4 or higher anemia, Grade 4 or higher neutropenia or lymphocytopenia lasting 7 days, Grade 3 or higher febrile neutropenia, Grade 4 or higher platelet count decreased. The severity of AEs was graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Japanese version). In addition, a DLT-equivalent treatment-emergent adverse event (TEAE) was defined as a DLT occurred during the extend treatment period (at Cycle 2 and thereafter).
Outcome measures
| Measure |
Dose Level 1
n=6 Participants
OCV-103 and OCV-104 (0.3 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 2
n=6 Participants
OCV-103 and OCV-104 (1 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 3
n=6 Participants
OCV-103 and OCV-104 (3 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 4
n=6 Participants
OCV-103 and OCV-104 (6 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
|---|---|---|---|---|
|
Dose Limiting Toxicity (DLT)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)The severity (grade) of an AE was evaluated using the 5-point scale from Grade 1 to Grade 5 in accordance with CTCAE version 4.0 (Japanese version) , where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences; Grade 5 = Death related to AE.
Outcome measures
| Measure |
Dose Level 1
n=6 Participants
OCV-103 and OCV-104 (0.3 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 2
n=6 Participants
OCV-103 and OCV-104 (1 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 3
n=6 Participants
OCV-103 and OCV-104 (3 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 4
n=6 Participants
OCV-103 and OCV-104 (6 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
|---|---|---|---|---|
|
Number of Subjects With CTCAE Grade 3 or Higher TEAEs
|
3 participants
|
4 participants
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Day 29Tumor response was graded in accordance with the new Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Complete Response (CR): Disappearance of all target lesions (any malignant lymph nodes selected as target lesions must have a reduction in the minor axis to \<10 mm) Partial Response (PR): At least a 30% decrease in the diameter sum of the target lesions as compared with the diameter sum at screening Progressive Disease (PD): At least a 20% increase in the diameter sum of the target lesions as compared with the smallest diameter sum recorded after the start of treatment, and at least 5 mm increase in the absolute increase of at least 5 mm Stable Disease (SD): Neither tumor shrinkage equivalent to PR nor tumor enlargement equivalent to PD Not Evaluable (NE): No examination is feasible or the tumor response cannot be considered as any of CR, PR, PD, and SD
Outcome measures
| Measure |
Dose Level 1
n=6 Participants
OCV-103 and OCV-104 (0.3 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 2
n=6 Participants
OCV-103 and OCV-104 (1 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 3
n=6 Participants
OCV-103 and OCV-104 (3 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 4
n=6 Participants
OCV-103 and OCV-104 (6 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
|---|---|---|---|---|
|
Tumor Response Rate in Cycle 1
CR
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Tumor Response Rate in Cycle 1
SD
|
66.7 percentage of participants
|
16.7 percentage of participants
|
83.3 percentage of participants
|
66.7 percentage of participants
|
|
Tumor Response Rate in Cycle 1
PD
|
33.3 percentage of participants
|
83.3 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
|
Tumor Response Rate in Cycle 1
PR
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Tumor Response Rate in Cycle 1
NE
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Dose Level 1
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Level 2
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Level 3
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Level 4
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1
n=6 participants at risk
OCV-103 and OCV-104 (0.3 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 2
n=6 participants at risk
OCV-103 and OCV-104 (1 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 3
n=6 participants at risk
OCV-103 and OCV-104 (3 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 4
n=6 participants at risk
OCV-103 and OCV-104 (6 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
|---|---|---|---|---|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Hepatobiliary disorders
Bile duct stenosi
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
General disorders
Gait disturbance
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
General disorders
Pyrexia
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
Other adverse events
| Measure |
Dose Level 1
n=6 participants at risk
OCV-103 and OCV-104 (0.3 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 2
n=6 participants at risk
OCV-103 and OCV-104 (1 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 3
n=6 participants at risk
OCV-103 and OCV-104 (3 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
Dose Level 4
n=6 participants at risk
OCV-103 and OCV-104 (6 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
|
|---|---|---|---|---|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Infections and infestations
Infection
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Infections and infestations
Tracheitis
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
33.3%
2/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Infections and infestations
Tinea infection
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
33.3%
2/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
33.3%
2/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Nervous system disorders
Memory impairment
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Nervous system disorders
Brain oedema
|
33.3%
2/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
33.3%
2/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Vascular disorders
Orthostatic hypotension
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
33.3%
2/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
33.3%
2/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
33.3%
2/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
33.3%
2/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
33.3%
2/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
33.3%
2/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
General disorders
Chills
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
General disorders
Fatigue
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
33.3%
2/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
General disorders
Injection site erythema
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
General disorders
Injection site induration
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
General disorders
Injection site reaction
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
50.0%
3/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
General disorders
Malaise
|
33.3%
2/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
General disorders
Oedema
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
General disorders
Pyrexia
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
33.3%
2/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
General disorders
Induration
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
33.3%
2/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
33.3%
2/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Investigations
Blood lactate dehydrogenase increased
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Investigations
Blood urea increased
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Investigations
Eosinophil count increased
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
33.3%
2/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Investigations
Blood urine present
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
33.3%
2/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
16.7%
1/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
0.00%
0/6 • TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
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