Trial Outcomes & Findings for Phase II Study of SyB D-0701 for Radiotherapy-Induced Nausea and Vomiting (RINV) (NCT NCT01700140)
NCT ID: NCT01700140
Last Updated: 2014-11-19
Results Overview
The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
189 participants
Primary outcome timeframe
72 hours
Results posted on
2014-11-19
Participant Flow
Participant milestones
| Measure |
Placebo Group
Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: Low Dose Group
Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: High Dose Group
Study drug patches \[High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
61
|
66
|
62
|
|
Overall Study
COMPLETED
|
55
|
57
|
61
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
1
|
Reasons for withdrawal
| Measure |
Placebo Group
Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: Low Dose Group
Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: High Dose Group
Study drug patches \[High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
|---|---|---|---|
|
Overall Study
Use of rescue drugs
|
3
|
3
|
1
|
|
Overall Study
Discontinuation of radiotherapy
|
1
|
0
|
0
|
|
Overall Study
Use of chemotherapy or surgical therapy
|
0
|
1
|
0
|
|
Overall Study
Aggravation of symptoms
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Inclusion/exclusion criteria deviation
|
1
|
4
|
0
|
Baseline Characteristics
Phase II Study of SyB D-0701 for Radiotherapy-Induced Nausea and Vomiting (RINV)
Baseline characteristics by cohort
| Measure |
Placebo Group
n=56 Participants
Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: Low Dose Group
n=59 Participants
Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: High Dose Group
n=60 Participants
Study drug patches \[High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
20-40 years
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Age, Customized
40-50 years
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Age, Customized
50-60 years
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Age, Customized
60-70 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Age, Customized
70≤ years
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Metastasis
Absent
|
32 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Metastasis
Present
|
24 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
History of radiotherapy
Absent
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
|
History of radiotherapy
Present
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
History of recent chemotherapy
Absent
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
History of recent chemotherapy
Present
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Complication
Absent
|
2 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Complication
Present
|
54 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
152 Participants
n=4 Participants
|
|
Diseases in the past 5 years
Absent
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Diseases in the past 5 years
Present
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
History of smoking habit
Absent
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
History of smoking habit
Present
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Alcohol consumption history
Absent
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Alcohol consumption history
Present
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Motion sickness (vehicle sickness)
Absent
|
54 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
|
Motion sickness (vehicle sickness)
Present
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Performance status
0
|
39 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
|
Performance status
1
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Performance status
2
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Nausea/emesis
Absent
|
56 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
|
Nausea/emesis
Present
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 72 hoursPopulation: Per protocol set: Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.
The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.
Outcome measures
| Measure |
Placebo Group
n=56 Participants
Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: Low Dose Group
n=59 Participants
Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: High Dose Group
n=60 Participants
Study drug patches \[High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
|---|---|---|---|
|
Complete Control (no Signs of Emesis or Moderate to Severe Nausea and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation
|
85.7 Percentage of participants
|
84.7 Percentage of participants
|
93.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Per protocol set: Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.
The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.
Outcome measures
| Measure |
Placebo Group
n=56 Participants
Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: Low Dose Group
n=59 Participants
Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: High Dose Group
n=60 Participants
Study drug patches \[High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
|---|---|---|---|
|
Complete Response (no Signs of Emesis and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation
|
89.3 Percentage of participants
|
88.1 Percentage of participants
|
96.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 24-72 hoursPopulation: Per protocol set: Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.
Time from the start of radiotherapy to the onset of first emesis. The median (50% point) of time to first emesis was estimated.
Outcome measures
| Measure |
Placebo Group
n=56 Participants
Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: Low Dose Group
n=59 Participants
Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: High Dose Group
n=60 Participants
Study drug patches \[High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
|---|---|---|---|
|
Time to First Emesis
|
NA Hours
The estimated non-incidence of emesis by the Kaplan-Meier method exceeded 50%.
|
NA Hours
The estimated non-incidence of emesis by the Kaplan-Meier method exceeded 50%.
|
NA Hours
The estimated non-incidence of emesis by the Kaplan-Meier method exceeded 50%.
|
SECONDARY outcome
Timeframe: 24-72 hoursPopulation: Per protocol set: Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.
Time from the start of radiotherapy to the onset of first nausea. The median (50% point) of time to first nausea was estimated.
Outcome measures
| Measure |
Placebo Group
n=56 Participants
Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: Low Dose Group
n=59 Participants
Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: High Dose Group
n=60 Participants
Study drug patches \[High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
|---|---|---|---|
|
Time to First Nausea
|
NA Hours
The estimated non-incidence of nausea by the Kaplan-Meier method exceeded 50%.
|
NA Hours
The estimated non-incidence of nausea by the Kaplan-Meier method exceeded 50%.
|
NA Hours
The estimated non-incidence of nausea by the Kaplan-Meier method exceeded 50%.
|
SECONDARY outcome
Timeframe: 24-72 hoursPopulation: Per protocol set: Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.
Complete control rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy. The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs.
Outcome measures
| Measure |
Placebo Group
n=56 Participants
Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: Low Dose Group
n=59 Participants
Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: High Dose Group
n=60 Participants
Study drug patches \[High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
|---|---|---|---|
|
Complete Control Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3
First irradiation
|
91.1 Percentage of participants
|
89.8 Percentage of participants
|
98.3 Percentage of participants
|
|
Complete Control Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3
Second irradiation
|
90.9 Percentage of participants
|
94.7 Percentage of participants
|
98.3 Percentage of participants
|
|
Complete Control Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3
Third irradiation
|
89.1 Percentage of participants
|
96.4 Percentage of participants
|
94.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 24-72 hoursPopulation: Per protocol set: Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set.
Complete response rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy. The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs.
Outcome measures
| Measure |
Placebo Group
n=56 Participants
Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: Low Dose Group
n=59 Participants
Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: High Dose Group
n=60 Participants
Study drug patches \[High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
|---|---|---|---|
|
Complete Response Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3
First irraditation
|
91.1 Percentage of participants
|
91.5 Percentage of participants
|
98.3 Percentage of participants
|
|
Complete Response Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3
Second irradiation
|
94.5 Percentage of participants
|
96.5 Percentage of participants
|
98.3 Percentage of participants
|
|
Complete Response Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3
Third irradiation
|
92.7 Percentage of participants
|
98.2 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 192 hoursPopulation: Safety population: The safety population consisted of all subjects enrolled, except for subjects with Good Clinical Practice (GCP) non-compliance and those who failed to receive the study treatment.
Adverse event is any untoward medical occurrence experienced by a subject irrespective of causal relationship with the study drug, and includes the unexpected signs, clinically significant fluctuations of laboratory data, and aggravation of disease, symptoms or complications. Adverse events are coded using the preferred terms (PT) of Medical Dictionary for Regulatory Activities (MedDRA) version 15.0.
Outcome measures
| Measure |
Placebo Group
n=60 Participants
Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: Low Dose Group
n=63 Participants
Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: High Dose Group
n=62 Participants
Study drug patches \[High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
|---|---|---|---|
|
Adverse Events
Number of subjects with any adverse event
|
51 Participants
|
55 Participants
|
45 Participants
|
|
Adverse Events
Number of subjects with adverse drug reaction
|
14 Participants
|
17 Participants
|
16 Participants
|
|
Adverse Events
Number of subjects with SAE
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
Number of death
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 192 hoursPopulation: Safety population: The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
The severity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. 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 |
Placebo Group
n=60 Participants
Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: Low Dose Group
n=63 Participants
Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: High Dose Group
n=62 Participants
Study drug patches \[High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
|---|---|---|---|
|
Severe (Grade 3 or More) Adverse Events
Grade 3 : lymphopenia
|
0 Number of events
|
1 Number of events
|
0 Number of events
|
|
Severe (Grade 3 or More) Adverse Events
Grade 3 : nausea
|
2 Number of events
|
0 Number of events
|
0 Number of events
|
|
Severe (Grade 3 or More) Adverse Events
Grade 3 : urethritis
|
0 Number of events
|
1 Number of events
|
0 Number of events
|
|
Severe (Grade 3 or More) Adverse Events
Grade 3 : lymph node abscess
|
1 Number of events
|
0 Number of events
|
0 Number of events
|
|
Severe (Grade 3 or More) Adverse Events
Grade 3 : blood pressure increased
|
0 Number of events
|
1 Number of events
|
0 Number of events
|
|
Severe (Grade 3 or More) Adverse Events
Grade 3 : C-reactive protein increased
|
1 Number of events
|
0 Number of events
|
0 Number of events
|
|
Severe (Grade 3 or More) Adverse Events
Grade 3 : lymphocyte count decreased
|
3 Number of events
|
7 Number of events
|
3 Number of events
|
|
Severe (Grade 3 or More) Adverse Events
Grade 3 : neutrophil count increased
|
1 Number of events
|
0 Number of events
|
0 Number of events
|
|
Severe (Grade 3 or More) Adverse Events
Grade 3 : white blood cell count decreased
|
3 Number of events
|
0 Number of events
|
0 Number of events
|
|
Severe (Grade 3 or More) Adverse Events
Grade 3 : blood alkaline phosphatase increased
|
0 Number of events
|
0 Number of events
|
1 Number of events
|
|
Severe (Grade 3 or More) Adverse Events
Grade 3 : hyponatraemia
|
0 Number of events
|
1 Number of events
|
0 Number of events
|
|
Severe (Grade 3 or More) Adverse Events
Grade 3 : decreased appetite
|
1 Number of events
|
0 Number of events
|
0 Number of events
|
|
Severe (Grade 3 or More) Adverse Events
Grade 3 : rash maculo-papular
|
0 Number of events
|
1 Number of events
|
0 Number of events
|
|
Severe (Grade 3 or More) Adverse Events
Grade 4 : lymphocyte count decreased
|
1 Number of events
|
0 Number of events
|
0 Number of events
|
SECONDARY outcome
Timeframe: Up to 192 hoursPopulation: Skin manifestations were counted for each type of patch applied to the subjects in the safety population. * Placebo patch : 60-1+63+60=182 (One subject in placebo group did not applied 15 cm2 patch.) * SyB D-0701 15 cm2 patch : 62 * SyB D-0701 25 cm2 patch : 62+63=125
The investigator or sub-investigator recorded skin manifestations observed after removal of the study drug. Skin manifestations were counted for each type of patches (placebo patch, SyB D-0701 15 cm2 patch, SyB D-0701 25 cm2 patch).
Outcome measures
| Measure |
Placebo Group
n=182 Participants
Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: Low Dose Group
n=62 Participants
Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: High Dose Group
n=125 Participants
Study drug patches \[High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
|---|---|---|---|
|
Skin Manifestations at Study Drug Application Site
Skin manifestations: reacted
|
15 Number of events
|
7 Number of events
|
14 Number of events
|
|
Skin Manifestations at Study Drug Application Site
Clearly identifiable erythema
|
12 Number of events
|
5 Number of events
|
12 Number of events
|
|
Skin Manifestations at Study Drug Application Site
Erythema + papules
|
3 Number of events
|
2 Number of events
|
2 Number of events
|
|
Skin Manifestations at Study Drug Application Site
Erythema + papules + small blisters
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
Adverse Events
Placebo Group
Serious events: 1 serious events
Other events: 51 other events
Deaths: 0 deaths
SyB D-0701: Low Dose Group
Serious events: 0 serious events
Other events: 55 other events
Deaths: 0 deaths
SyB D-0701: High Dose Group
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Group
n=60 participants at risk
Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: Low Dose Group
n=63 participants at risk
Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: High Dose Group
n=62 participants at risk
Study drug patches \[High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
|---|---|---|---|
|
Infections and infestations
Lymph node abscess
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
Other adverse events
| Measure |
Placebo Group
n=60 participants at risk
Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: Low Dose Group
n=63 participants at risk
Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
SyB D-0701: High Dose Group
n=62 participants at risk
Study drug patches \[High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
3.2%
2/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
6.3%
4/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
3.2%
2/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.0%
3/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
4.8%
3/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
22.2%
14/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
11.3%
7/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.0%
9/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
9.5%
6/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
4.8%
3/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
3.2%
2/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
10/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
12.7%
8/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
14.5%
9/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
3.2%
2/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
General disorders
Application site dermatitis
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
General disorders
Application site erythema
|
10.0%
6/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
14.3%
9/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
14.5%
9/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
General disorders
Application site pruritus
|
15.0%
9/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
7.9%
5/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
16.1%
10/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
General disorders
Application site rash
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
General disorders
Malaise
|
3.3%
2/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
3.2%
2/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
3.2%
2/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
General disorders
Oedema peripheral
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
General disorders
Application site vesicles
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
General disorders
Application site papules
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
3.2%
2/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
General disorders
Application site swelling
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
General disorders
Disease progression
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Infections and infestations
Urethritis
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Injury, poisoning and procedural complications
Radiation associated pain
|
5.0%
3/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
3.2%
2/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
4.8%
3/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Blood bilirubin increased
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Blood creatinine increased
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
C-reactive protein increased
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Glucose urine present
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Lymphocyte count decreased
|
50.0%
30/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
52.4%
33/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
46.8%
29/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Neutrophil count decreased
|
5.0%
3/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
3.2%
2/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
4.8%
3/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Neutrophil count increased
|
3.3%
2/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Platelet count decreased
|
3.3%
2/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Protein total decreased
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Weight decreased
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Weight increased
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
White blood cell count decreased
|
26.7%
16/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
20.6%
13/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
22.6%
14/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
White blood cell count increased
|
3.3%
2/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Platelet count increased
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
3.2%
2/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Blood pressure increased
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.3%
2/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
2/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
5.0%
3/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
3.2%
2/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Psychiatric disorders
Insomnia
|
6.7%
4/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
3.2%
2/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.7%
1/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
1.6%
1/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
0.00%
0/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
6/60 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
6.3%
4/63 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
4.8%
3/62 • Up to 192 hours
The safety population was used in the analysis of adverse events. The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment.
|
Additional Information
Nobuyuki Koseki
SymBio Pharmaceuticals
Phone: +81-3-5472-1127
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results without prior approval from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER