Trial Outcomes & Findings for ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan (NCT NCT00836888)
NCT ID: NCT00836888
Last Updated: 2020-10-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation
Results posted on
2020-10-08
Participant Flow
Participant milestones
| Measure |
ONO-4538 1mg/kg Cohorts
Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 3mg/kg Cohorts
Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 10mg/kg Cohorts
Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 20mg/kg Cohorts
Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
6
|
3
|
|
Overall Study
COMPLETED
|
0
|
2
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan
Baseline characteristics by cohort
| Measure |
ONO-4538 1mg/kg Cohorts
n=3 Participants
Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 3mg/kg Cohorts
n=5 Participants
Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 10mg/kg Cohorts
n=6 Participants
Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 20mg/kg Cohorts
n=3 Participants
Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Performance Status（ECOG）
0
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Performance Status（ECOG）
1
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
disease stage classification
IV
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
disease stage classification
IVb
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
disease stage classification
Recurrent
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Cancer treatment history (surgery)
None
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Cancer treatment history (surgery)
Present
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Cancer treatment history (radiotherapy)
None
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Cancer treatment history (radiotherapy)
Present
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Cancer treatment history (drug therapy)
None
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Cancer treatment history (drug therapy)
Present
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuationOutcome measures
| Measure |
ONO-4538 1mg/kg Cohorts
n=3 Participants
Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 3mg/kg Cohorts
n=5 Participants
Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 10mg/kg Cohorts
n=6 Participants
Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 20mg/kg Cohorts
n=3 Participants
Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
|
|---|---|---|---|---|
|
Cmax at Single Dose
|
24.4 μg/mL
Standard Deviation 4.5
|
68.8 μg/mL
Standard Deviation 10.9
|
192 μg/mL
Standard Deviation 36
|
214 μg/mL
Standard Deviation 68
|
PRIMARY outcome
Timeframe: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuationOutcome measures
| Measure |
ONO-4538 1mg/kg Cohorts
n=3 Participants
Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 3mg/kg Cohorts
n=5 Participants
Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 10mg/kg Cohorts
n=6 Participants
Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 20mg/kg Cohorts
n=3 Participants
Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
|
|---|---|---|---|---|
|
AUClast at Single Dose
|
4950 μg·h/mL
Standard Deviation 580
|
12300 μg·h/mL
Standard Deviation 4500
|
43900 μg·h/mL
Standard Deviation 7200
|
67400 μg·h/mL
Standard Deviation 15500
|
PRIMARY outcome
Timeframe: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuationOutcome measures
| Measure |
ONO-4538 1mg/kg Cohorts
n=3 Participants
Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 3mg/kg Cohorts
n=5 Participants
Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 10mg/kg Cohorts
n=6 Participants
Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 20mg/kg Cohorts
n=3 Participants
Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
|
|---|---|---|---|---|
|
T1/2 at Single Dose
|
15 day
Standard Deviation 0
|
13 day
Standard Deviation 7
|
21 day
Standard Deviation 11
|
17 day
Standard Deviation 9
|
PRIMARY outcome
Timeframe: day 15Ceoi：Serum concentrations immediately after the end of continuous administration
Outcome measures
| Measure |
ONO-4538 1mg/kg Cohorts
n=3 Participants
Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 3mg/kg Cohorts
n=5 Participants
Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 10mg/kg Cohorts
n=6 Participants
Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 20mg/kg Cohorts
n=3 Participants
Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
|
|---|---|---|---|---|
|
Ceoi at Multiple Doses
|
29.3 μg/mL
Standard Deviation 6.0
|
101 μg/mL
Standard Deviation 12
|
270 μg/mL
Standard Deviation 42
|
286 μg/mL
Standard Deviation 112
|
SECONDARY outcome
Timeframe: up to study completion, every 4 weeks in principleResponse Evaluation Criteria In Solid Tumors Criteria (ver 1.0) was used for this Outcome Measure. Please see the reference for the detailed description. Therasse, Arbuck et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-16.
Outcome measures
| Measure |
ONO-4538 1mg/kg Cohorts
n=3 Participants
Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 3mg/kg Cohorts
n=5 Participants
Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 10mg/kg Cohorts
n=6 Participants
Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 20mg/kg Cohorts
n=3 Participants
Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
|
|---|---|---|---|---|
|
Best Overall Response
CR
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response
PR
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Best Overall Response
SD
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Best Overall Response
Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response
PD
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
Adverse Events
ONO-4538 1mg/kg Cohorts
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
ONO-4538 3mg/kg Cohorts
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
ONO-4538 10mg/kg Cohorts
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
ONO-4538 20mg/kg Cohorts
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ONO-4538 1mg/kg Cohorts
n=3 participants at risk
Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 3mg/kg Cohorts
n=5 participants at risk
Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 10mg/kg Cohorts
n=6 participants at risk
Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 20mg/kg Cohorts
n=3 participants at risk
Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
malignant neoplasm progression
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
alanine aminotransferase increased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
aspartate aminotransferase increased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
blood bilirubin increased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
Other adverse events
| Measure |
ONO-4538 1mg/kg Cohorts
n=3 participants at risk
Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 3mg/kg Cohorts
n=5 participants at risk
Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 10mg/kg Cohorts
n=6 participants at risk
Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour
|
ONO-4538 20mg/kg Cohorts
n=3 participants at risk
Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
|
|---|---|---|---|---|
|
Investigations
Red blood cells urine positive
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Weight increased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
White blood cell count increased
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Platelet count increased
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Protein urine present
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Tri-iodothyronine free decreased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Thyroxine free decreased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Rheumatoid factor increased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Blood alkaline phosphatese increased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Interleukin level increased
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Antinuclear antibody increased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
50.0%
3/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
66.7%
2/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
40.0%
2/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
66.7%
2/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Headache
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Nervous system disorders
Hypoaeshesia
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Nervous system disorders
Sensory disturbance
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Nervous system disorders
Phrenic nerve paralysis
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
66.7%
2/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Dematitis acneiform
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
40.0%
2/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythodysaethesia syndrome
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
2/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
40.0%
2/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
2/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Vascular disorders
Flushing
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Cardiac disorders
Atrial fiblillation
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Cardiac disorders
Venticular extrasystoles
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
2/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
40.0%
2/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
2/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
60.0%
3/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
2/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
66.7%
2/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
40.0%
2/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
General disorders
Fatigue
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
2/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
General disorders
Malaise
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
2/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
General disorders
Pain
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
40.0%
2/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
2/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
66.7%
2/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Ammonia increased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Blood albumin decreased
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
60.0%
3/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
2/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
66.7%
2/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Blood creatine phosphokinase increased
|
66.7%
2/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
2/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
2/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Blood glucose increased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
50.0%
3/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Blood potassium decreased
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Blood potassium increased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Blood sodium decreased
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Blood triglycerides increased
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Blood uric acid increrased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
50.0%
3/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
C-reactive protein increased
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
40.0%
2/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
2/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
66.7%
2/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Eosinophil count increased
|
66.7%
2/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
60.0%
3/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
2/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Haematocrit decreased
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
60.0%
3/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
2/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Haematocrit increased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Blood urine preasent
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Haemoglobin decreased
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
60.0%
3/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
2/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
16.7%
1/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
40.0%
2/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
83.3%
5/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
66.7%
2/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
40.0%
2/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Neutrophil count increased
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
20.0%
1/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Protein total decreased
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
60.0%
3/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
|
Investigations
Red blood cell count decreased
|
33.3%
1/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
60.0%
3/5 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/6 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
0.00%
0/3 • All subjects treated with the study drug were followed up for at least 28 days after the last dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place