Trial Outcomes & Findings for Study to Assess the Safety of AZD1480 in Patients With Myeloproliferative Diseases (NCT NCT00910728)
NCT ID: NCT00910728
Last Updated: 2017-04-24
Results Overview
Single dose AUC0-12 (ug\*h/L)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
65 participants
Primary outcome timeframe
0 to 12 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post dose)
Results posted on
2017-04-24
Participant Flow
Commenced 19MAY2009. All subjects recruited to Part A only (based on emerging data). 65 patients were enrolled of which 35 recieved at least 1 dose of AZD1480.
Patients ≥25 years of age with primary myelofibrosis (MF) and post-polycythaemia vera/essential thrombocythaemia MF who had relapsed, were intolerant of, or were refractory to MF-directed therapy were enrolled.
Participant milestones
| Measure |
2.5 mg QD
AZD1480 may be administered orally in capsules
|
5.0 mg QD
AZD1480 may be administered orally in capsules
|
10 mg QD
AZD1480 may be administered orally in capsules
|
30 mg QD
AZD1480 may be administered orally in capsules
|
50 mg QD
AZD1480 may be administered orally in capsules
|
70 mg QD
AZD1480 may be administered orally in capsules
|
10 mg BID
AZD1480 may be administered orally in capsules
|
15 mg BID
AZD1480 may be administered orally in capsules
|
20 mg QD
AZD1480 may be administered orally in capsules
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
3
|
3
|
6
|
1
|
6
|
4
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
3
|
3
|
5
|
1
|
6
|
3
|
3
|
Reasons for withdrawal
| Measure |
2.5 mg QD
AZD1480 may be administered orally in capsules
|
5.0 mg QD
AZD1480 may be administered orally in capsules
|
10 mg QD
AZD1480 may be administered orally in capsules
|
30 mg QD
AZD1480 may be administered orally in capsules
|
50 mg QD
AZD1480 may be administered orally in capsules
|
70 mg QD
AZD1480 may be administered orally in capsules
|
10 mg BID
AZD1480 may be administered orally in capsules
|
15 mg BID
AZD1480 may be administered orally in capsules
|
20 mg QD
AZD1480 may be administered orally in capsules
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
3
|
1
|
2
|
1
|
0
|
2
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
3
|
1
|
2
|
0
|
0
|
|
Overall Study
(not specified)
|
2
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
1
|
0
|
0
|
2
|
1
|
1
|
Baseline Characteristics
Study to Assess the Safety of AZD1480 in Patients With Myeloproliferative Diseases
Baseline characteristics by cohort
| Measure |
2.5 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
5.0 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
10 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
70 mg QD
n=1 Participants
AZD1480 may be administered orally in capsules
|
15 mg BID
n=4 Participants
AZD1480 may be administered orally in capsules
|
30 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
50 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
10 mg BID
n=6 Participants
AZD1480 may be administered orally in capsules
|
20 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
76.7 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
56.0 years
STANDARD_DEVIATION 0 • n=4 Participants
|
66.5 years
STANDARD_DEVIATION 10.3 • n=21 Participants
|
49.3 years
STANDARD_DEVIATION 4.2 • n=10 Participants
|
69.3 years
STANDARD_DEVIATION 3.8 • n=115 Participants
|
65.3 years
STANDARD_DEVIATION 11.3 • n=6 Participants
|
75.7 years
STANDARD_DEVIATION 3.8 • n=6 Participants
|
65.1 years
STANDARD_DEVIATION 10.6 • n=64 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
14 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
21 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: 0 to 12 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post dose)Population: Pharmacokinetic. Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).
Single dose AUC0-12 (ug\*h/L)
Outcome measures
| Measure |
2.5 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
5.0 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
10 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
30 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
70 mg QD
n=1 Participants
AZD1480 may be administered orally in capsules
|
10 mg BID
n=6 Participants
AZD1480 may be administered orally in capsules
|
15 mg BID
n=4 Participants
AZD1480 may be administered orally in capsules
|
50 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
20 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameters Following Single Dosing: AUC0-12
|
69.2 ug*h/L
Standard Deviation 27.5
|
295 ug*h/L
Standard Deviation 68.2
|
278 ug*h/L
Standard Deviation 257
|
1860 ug*h/L
Standard Deviation 546
|
5800 ug*h/L
Standard Deviation 0
|
425 ug*h/L
Standard Deviation 190
|
497 ug*h/L
Standard Deviation 191
|
3090 ug*h/L
Standard Deviation 2060
|
472 ug*h/L
Standard Deviation 257
|
PRIMARY outcome
Timeframe: 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)Population: Pharmacokinetic. Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available). From the BID schedule we can not derive the single dosing AUC0\_24 and hence this is not presented/calculated.
Single dose AUC0-24 (ug\*h/L)
Outcome measures
| Measure |
2.5 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
5.0 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
10 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
30 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
70 mg QD
n=1 Participants
AZD1480 may be administered orally in capsules
|
10 mg BID
AZD1480 may be administered orally in capsules
|
15 mg BID
AZD1480 may be administered orally in capsules
|
50 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
20 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameters Following Single Dosing: AUC0-24
|
70.2 ug*h/L
Standard Deviation 28.7
|
308 ug*h/L
Standard Deviation 76
|
285 ug*h/L
Standard Deviation 252
|
2000 ug*h/L
Standard Deviation 624
|
6260 ug*h/L
Standard Deviation 0
|
—
|
—
|
3540 ug*h/L
Standard Deviation 2570
|
508 ug*h/L
Standard Deviation 280
|
PRIMARY outcome
Timeframe: 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)Population: Pharmacokinetic. Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available). From the BID (twice a day dosing schedules) we can not derive the PK parameter AUC0\_inf following single dosing. With that these do not contribute.
Single dose AUC(0 to infinity) (ug\*h/L)
Outcome measures
| Measure |
2.5 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
5.0 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
10 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
30 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
70 mg QD
n=1 Participants
AZD1480 may be administered orally in capsules
|
10 mg BID
AZD1480 may be administered orally in capsules
|
15 mg BID
AZD1480 may be administered orally in capsules
|
50 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
20 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameters Following Single Dosing:AUC0-inf
|
83.5 ug*h/L
Standard Deviation 36.6
|
312 ug*h/L
Standard Deviation 79.5
|
378 ug*h/L
Standard Deviation 290
|
2040 ug*h/L
Standard Deviation 657
|
6300 ug*h/L
Standard Deviation 0
|
—
|
—
|
3650 ug*h/L
Standard Deviation 2980
|
517 ug*h/L
Standard Deviation 294
|
PRIMARY outcome
Timeframe: On Days 1 and 28 at 0, 0,5, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose, and at 0, 2, 4 hours post dose on Days 4 and 10Population: Pharmacokinetic. Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).
Multiple dose Cmax,ss (ug/L)
Outcome measures
| Measure |
2.5 mg QD
n=5 Participants
AZD1480 may be administered orally in capsules
|
5.0 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
10 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
30 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
70 mg QD
n=1 Participants
AZD1480 may be administered orally in capsules
|
10 mg BID
n=5 Participants
AZD1480 may be administered orally in capsules
|
15 mg BID
n=4 Participants
AZD1480 may be administered orally in capsules
|
50 mg QD
n=5 Participants
AZD1480 may be administered orally in capsules
|
20 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameters Following Multiple Dosing: Cmax,ss
|
51.3 ug/L
Standard Deviation 18
|
134 ug/L
Standard Deviation 36.3
|
176 ug/L
Standard Deviation 179
|
658 ug/L
Standard Deviation 265
|
1500 ug/L
Standard Deviation 0
|
218 ug/L
Standard Deviation 72.3
|
334 ug/L
Standard Deviation 68.2
|
924 ug/L
Standard Deviation 461
|
241 ug/L
Standard Deviation 346
|
PRIMARY outcome
Timeframe: On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose and at 0, 2, 4 hours post-dose on Days 4 and 10.Population: Pharmacokinetic. Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).
Multiple dose Cmin,ss (ug/L)
Outcome measures
| Measure |
2.5 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
5.0 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
10 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
30 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
70 mg QD
n=1 Participants
AZD1480 may be administered orally in capsules
|
10 mg BID
n=6 Participants
AZD1480 may be administered orally in capsules
|
15 mg BID
n=4 Participants
AZD1480 may be administered orally in capsules
|
50 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
20 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameters Following Multiple Dosing: Cmin,ss
|
69.2 ug/L
Standard Deviation 27.5
|
295 ug/L
Standard Deviation 68.2
|
278 ug/L
Standard Deviation 257
|
1860 ug/L
Standard Deviation 546
|
5800 ug/L
Standard Deviation 0
|
425 ug/L
Standard Deviation 190
|
497 ug/L
Standard Deviation 191
|
3090 ug/L
Standard Deviation 2060
|
472 ug/L
Standard Deviation 257
|
PRIMARY outcome
Timeframe: 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)Population: Pharmacokinetic. Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).
Single dose Cmax (ug/L)
Outcome measures
| Measure |
2.5 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
5.0 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
10 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
30 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
70 mg QD
n=1 Participants
AZD1480 may be administered orally in capsules
|
10 mg BID
n=6 Participants
AZD1480 may be administered orally in capsules
|
15 mg BID
n=4 Participants
AZD1480 may be administered orally in capsules
|
50 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
20 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameters Following Single Dosing: Cmax
|
69.9 ug/L
Standard Deviation 32.7
|
133 ug/L
Standard Deviation 54.7
|
157 ug/L
Standard Deviation 145
|
739 ug/L
Standard Deviation 307
|
2600 ug/L
Standard Deviation 0
|
273 ug/L
Standard Deviation 62.2
|
324 ug/L
Standard Deviation 79.5
|
1320 ug/L
Standard Deviation 379
|
268 ug/L
Standard Deviation 227
|
PRIMARY outcome
Timeframe: 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)Population: Pharmacokinetic. Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available). Due to the nature of the dosing schedule this PK parameter was not reported for the BID (twice daily dosing) groups.
Single dose Vz/F (L)
Outcome measures
| Measure |
2.5 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
5.0 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
10 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
30 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
70 mg QD
n=1 Participants
AZD1480 may be administered orally in capsules
|
10 mg BID
AZD1480 may be administered orally in capsules
|
15 mg BID
AZD1480 may be administered orally in capsules
|
50 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
20 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameters Following Single Dosing: Vz/F
|
222 L
Standard Deviation 125
|
108 L
Standard Deviation 28.1
|
138 L
Standard Deviation 161
|
97 L
Standard Deviation 15
|
57.9 L
Standard Deviation 0
|
—
|
—
|
105 L
Standard Deviation 82.2
|
284 L
Standard Deviation 92.3
|
PRIMARY outcome
Timeframe: 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)Population: Pharmacokinetic. Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).
Single dose CL/F (L/h)
Outcome measures
| Measure |
2.5 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
5.0 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
10 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
30 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
70 mg QD
n=1 Participants
AZD1480 may be administered orally in capsules
|
10 mg BID
n=6 Participants
AZD1480 may be administered orally in capsules
|
15 mg BID
n=4 Participants
AZD1480 may be administered orally in capsules
|
50 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
20 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameters Following Single Dosing: CL/F
|
35.2 L/h
Standard Deviation 13.9
|
16 L/h
Standard Deviation 4.25
|
34.8 L/h
Standard Deviation 22.5
|
14.7 L/h
Standard Deviation 5.52
|
11.1 L/h
Standard Deviation 0
|
22.6 L/h
Standard Deviation 9.05
|
29.7 L/h
Standard Deviation 13
|
13.8 L/h
Standard Deviation 8.5
|
38.7 L/h
Standard Deviation 16.7
|
PRIMARY outcome
Timeframe: On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post dose and at 0, 2, 4 hours post-dosePopulation: Pharmacokinetic. Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).
Multiple dose CLss/F (L/h)
Outcome measures
| Measure |
2.5 mg QD
n=5 Participants
AZD1480 may be administered orally in capsules
|
5.0 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
10 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
30 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
70 mg QD
n=1 Participants
AZD1480 may be administered orally in capsules
|
10 mg BID
n=5 Participants
AZD1480 may be administered orally in capsules
|
15 mg BID
n=4 Participants
AZD1480 may be administered orally in capsules
|
50 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
20 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameters Following Multiple Dosing: CLss/F
|
37.8 L/h
Standard Deviation 6
|
15.8 L/h
Standard Deviation 4.4
|
30.1 L/h
Standard Deviation 21.7
|
17 L/h
Standard Deviation 5.26
|
9.57 L/h
Standard Deviation 0
|
20 L/h
Standard Deviation 6.91
|
20.4 L/h
Standard Deviation 13.8
|
16 L/h
Standard Deviation 8.94
|
20.8 L/h
Standard Deviation 21
|
PRIMARY outcome
Timeframe: 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)Single dose Tmax (h)
Outcome measures
| Measure |
2.5 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
5.0 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
10 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
30 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
70 mg QD
n=1 Participants
AZD1480 may be administered orally in capsules
|
10 mg BID
n=6 Participants
AZD1480 may be administered orally in capsules
|
15 mg BID
n=4 Participants
AZD1480 may be administered orally in capsules
|
50 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
20 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharamcokinetic Parameters Following Single Dosing: Tmax
|
0.625 h
Interval 0.5 to 1.5
|
0.75 h
Interval 0.5 to 2.0
|
0.75 h
Interval 0.5 to 0.75
|
1 h
Interval 1.0 to 1.5
|
0.75 h
Interval 0.75 to 0.75
|
0.625 h
Interval 0.5 to 1.0
|
0.875 h
Interval 0.5 to 1.0
|
0.89 h
Interval 0.75 to 1.5
|
0.75 h
Interval 0.5 to 1.03
|
PRIMARY outcome
Timeframe: On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose and at 0, 2, 4 hours post-dose on Days 4 and 10Multiple dose Tmax,ss (h)
Outcome measures
| Measure |
2.5 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
5.0 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
10 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
30 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
70 mg QD
n=1 Participants
AZD1480 may be administered orally in capsules
|
10 mg BID
n=6 Participants
AZD1480 may be administered orally in capsules
|
15 mg BID
n=4 Participants
AZD1480 may be administered orally in capsules
|
50 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
20 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharamcokinetic Parameters Following Multiple Dosing: Tmax,ss
|
0.5 h
Interval 0.5 to 1.0
|
0.78 h
Interval 0.75 to 1.0
|
0.77 h
Interval 0.75 to 1.0
|
0.75 h
Interval 0.52 to 1.0
|
1.5 h
Interval 1.5 to 1.5
|
1 h
Interval 0.5 to 1.5
|
0.875 h
Interval 0.75 to 1.5
|
0.78 h
Interval 0.25 to 2.25
|
1 h
Interval 0.75 to 3.0
|
PRIMARY outcome
Timeframe: 2hrs and 4 hrs post dosePSTAT3 inhinition
Outcome measures
| Measure |
2.5 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
5.0 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
10 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
30 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
70 mg QD
n=1 Participants
AZD1480 may be administered orally in capsules
|
10 mg BID
n=6 Participants
AZD1480 may be administered orally in capsules
|
15 mg BID
n=4 Participants
AZD1480 may be administered orally in capsules
|
50 mg QD
n=6 Participants
AZD1480 may be administered orally in capsules
|
20 mg QD
n=3 Participants
AZD1480 may be administered orally in capsules
|
|---|---|---|---|---|---|---|---|---|---|
|
Inhibition of PSTAT3 (Count)
2 Hours post dose
|
0 # patients with 50% reduction in PSTAT3
|
0 # patients with 50% reduction in PSTAT3
|
0 # patients with 50% reduction in PSTAT3
|
1 # patients with 50% reduction in PSTAT3
|
0 # patients with 50% reduction in PSTAT3
|
0 # patients with 50% reduction in PSTAT3
|
0 # patients with 50% reduction in PSTAT3
|
3 # patients with 50% reduction in PSTAT3
|
0 # patients with 50% reduction in PSTAT3
|
|
Inhibition of PSTAT3 (Count)
4 Hours post dose
|
0 # patients with 50% reduction in PSTAT3
|
0 # patients with 50% reduction in PSTAT3
|
0 # patients with 50% reduction in PSTAT3
|
0 # patients with 50% reduction in PSTAT3
|
0 # patients with 50% reduction in PSTAT3
|
1 # patients with 50% reduction in PSTAT3
|
0 # patients with 50% reduction in PSTAT3
|
0 # patients with 50% reduction in PSTAT3
|
0 # patients with 50% reduction in PSTAT3
|
Adverse Events
2.5 mg QD
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
5.0 mg QD
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
10 mg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
70 mg QD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
15 mg BID
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
20 mg QD
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
30 mg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
50 mg QD
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
10 mg BID
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2.5 mg QD
n=6 participants at risk
AZD1480 may be administered orally in capsules
|
5.0 mg QD
n=3 participants at risk
AZD1480 may be administered orally in capsules
|
10 mg QD
n=3 participants at risk
AZD1480 may be administered orally in capsules
|
70 mg QD
n=1 participants at risk
AZD1480 may be administered orally in capsules
|
15 mg BID
n=4 participants at risk
AZD1480 may be administered orally in capsules
|
20 mg QD
n=3 participants at risk
AZD1480 may be administered orally in capsules
|
30 mg QD
n=3 participants at risk
AZD1480 may be administered orally in capsules
|
50 mg QD
n=6 participants at risk
AZD1480 may be administered orally in capsules
|
10 mg BID
n=6 participants at risk
AZD1480 may be administered orally in capsules
|
|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
APHASIA
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Nervous system disorders
AMNESIA
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Nervous system disorders
ATAXIA
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Nervous system disorders
DYSARTHRIA
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
25.0%
1/4 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Cardiac disorders
ATRIAL FLUTTER/FIBRILLATION
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Blood and lymphatic system disorders
SPLENIC INFARCTION
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Cardiac disorders
CARDIAC FAILURE CHRONIC
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
General disorders
PYREXIA
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Infections and infestations
PNEUMONIA
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Injury, poisoning and procedural complications
CRANIOCEREBRAL INJURY
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
25.0%
1/4 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
25.0%
1/4 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Metabolism and nutrition disorders
GOUT
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
Other adverse events
| Measure |
2.5 mg QD
n=6 participants at risk
AZD1480 may be administered orally in capsules
|
5.0 mg QD
n=3 participants at risk
AZD1480 may be administered orally in capsules
|
10 mg QD
n=3 participants at risk
AZD1480 may be administered orally in capsules
|
70 mg QD
n=1 participants at risk
AZD1480 may be administered orally in capsules
|
15 mg BID
n=4 participants at risk
AZD1480 may be administered orally in capsules
|
20 mg QD
n=3 participants at risk
AZD1480 may be administered orally in capsules
|
30 mg QD
n=3 participants at risk
AZD1480 may be administered orally in capsules
|
50 mg QD
n=6 participants at risk
AZD1480 may be administered orally in capsules
|
10 mg BID
n=6 participants at risk
AZD1480 may be administered orally in capsules
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
66.7%
4/6 • Number of events 4 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Blood and lymphatic system disorders
NEUTROPENIUA
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
25.0%
1/4 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
2/6 • Number of events 2 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
25.0%
1/4 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
2/6 • Number of events 2 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
General disorders
FATIGUE
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
General disorders
ASTHENIA
|
33.3%
2/6 • Number of events 2 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
66.7%
2/3 • Number of events 2 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
66.7%
4/6 • Number of events 4 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Investigations
WEIGHT INCREASE
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
25.0%
1/4 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
100.0%
1/1 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
66.7%
2/3 • Number of events 2 • Throughout study continuously and 30 days post discontinuation of treatment
|
50.0%
3/6 • Number of events 3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
100.0%
1/1 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
100.0%
1/1 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
—
0/0 • Throughout study continuously and 30 days post discontinuation of treatment
|
100.0%
1/1 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
100.0%
1/1 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
100.0%
1/1 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
100.0%
1/1 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
100.0%
2/2 • Number of events 2 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
General disorders
PYREXIA
|
33.3%
2/6 • Number of events 2 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
General disorders
HYPERTHERMIA
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
General disorders
OEMEMA PERIPHERAL
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
100.0%
1/1 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
50.0%
2/4 • Number of events 2 • Throughout study continuously and 30 days post discontinuation of treatment
|
66.7%
2/3 • Number of events 2 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
2/6 • Number of events 2 • Throughout study continuously and 30 days post discontinuation of treatment
|
50.0%
3/6 • Number of events 3 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
General disorders
OEDEMA
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
100.0%
1/1 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Infections and infestations
FOLLICULITIS
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Renal and urinary disorders
PROTEINURIA
|
50.0%
3/6 • Number of events 3 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Gastrointestinal disorders
ASCITES
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
66.7%
2/3 • Number of events 2 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
2/6 • Number of events 2 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
25.0%
1/4 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
2/6 • Number of events 2 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
66.7%
2/3 • Number of events 2 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
25.0%
1/4 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
2/6 • Number of events 2 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Musculoskeletal and connective tissue disorders
MYALGIA AGGRAVATED
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
25.0%
1/4 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Musculoskeletal and connective tissue disorders
PAIN
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
25.0%
1/4 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Eye disorders
RETINAL HAEMORRHAGE
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
25.0%
1/4 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Eye disorders
CATARAC
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
25.0%
1/4 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
2/6 • Number of events 2 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
25.0%
1/4 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Eye disorders
DRY EYE
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
50.0%
3/6 • Number of events 3 • Throughout study continuously and 30 days post discontinuation of treatment
|
50.0%
3/6 • Number of events 3 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Eye disorders
HAEMORRHAGE
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Eye disorders
KERATITI
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
2/6 • Number of events 2 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
25.0%
1/4 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSI
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
25.0%
1/4 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Skin and subcutaneous tissue disorders
PRURITIS
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
25.0%
1/4 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Investigations
CARDIAC MURMUR
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
100.0%
1/1 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Nervous system disorders
PARAESTHES
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
25.0%
1/4 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
EPITAXIS
|
16.7%
1/6 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
33.3%
1/3 • Number of events 1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/1 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/4 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/3 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
0.00%
0/6 • Throughout study continuously and 30 days post discontinuation of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER