Trial Outcomes & Findings for A Study of LY3164530 in Participants With Cancer (NCT NCT02221882)
NCT ID: NCT02221882
Last Updated: 2019-10-23
Results Overview
Recommended Phase 2 Dose of LY3164530: MTD
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
Cycle 1 (Cycle = 28 days)
Results posted on
2019-10-23
Participant Flow
Participants, who completed at least 1 cycle of treatment or discontinued due to an adverse event during Cycle 1 and completed the required post-treatment safety assessment, were considered to have completed the study.
Participant milestones
| Measure |
300 mg LY3164530 Schedule 1
300 mg LY3164530 given intravenously (IV) on Days 1 and 15 of each 28 day cycle.
|
600 mg LY3164530 Schedule 1
600 mg LY3164530 given IV on Days 1, and 15 of each 28 day cycle.
|
1000 mg LY3164530 Schedule 1
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
1250 mg LY3164530 Schedule 1
1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
500 mg LY3164530 Schedule 2
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
600 mg LY3164530 Schedule 2
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
11
|
3
|
5
|
4
|
|
Overall Study
Received at Least One Dose of Study Drug
|
3
|
3
|
11
|
3
|
5
|
4
|
|
Overall Study
COMPLETED
|
3
|
2
|
7
|
1
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
4
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
300 mg LY3164530 Schedule 1
300 mg LY3164530 given intravenously (IV) on Days 1 and 15 of each 28 day cycle.
|
600 mg LY3164530 Schedule 1
600 mg LY3164530 given IV on Days 1, and 15 of each 28 day cycle.
|
1000 mg LY3164530 Schedule 1
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
1250 mg LY3164530 Schedule 1
1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
500 mg LY3164530 Schedule 2
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
600 mg LY3164530 Schedule 2
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
4
|
2
|
2
|
2
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY3164530 in Participants With Cancer
Baseline characteristics by cohort
| Measure |
300 mg LY3164530 Schedule 1
n=3 Participants
300 mg LY3164530 given intravenously (IV) on Days 1 and 15 of each 28 day cycle.
|
600 mg LY3164530 Schedule 1
n=3 Participants
600 mg LY3164530 given IV on Days 1, and 15 of each 28 day cycle.
|
1000 mg LY3164530 Schedule 1
n=11 Participants
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
1250 mg LY3164530 Schedule 1
n=3 Participants
1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
500 mg LY3164530 Schedule 2
n=5 Participants
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
600 mg LY3164530 Schedule 2
n=4 Participants
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
Total
n=29 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
29 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Cycle = 28 days)Population: All participants who receive at least one dose of study drug.
Recommended Phase 2 Dose of LY3164530: MTD
Outcome measures
| Measure |
Schedule 1
n=20 Participants
LY3164530 in escalating dose cohorts of 300mg, 600mg, 1000mg and 1250mg given intravenously (IV) once on Days 1, 8, 15, and 22 of a 28-day cycle.
|
Schedule 2
n=9 Participants
LY3164530 in escalating dose cohorts of 500 mg or 600 mg given intravenously (IV) once on Days 1 and 15 of a 28-day cycle.
|
1000 mg LY3164530 Schedule 1
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
1250 mg LY3164530 Schedule 1
1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
500 mg LY3164530 Schedule 2
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
600 mg LY3164530 Schedule 2
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
|---|---|---|---|---|---|---|
|
Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD)
|
1000 milligrams (mg)
|
500 milligrams (mg)
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)Population: All participants who received at least one dose of study drug and had evaluable PK data.
Cmax in Schedule (Sched) 1 Cycle 1 (C1) and Cycle 2 (C2) and Sched. 2 C1 and C2 dose escalation based on EGFR specific ELISA assay. Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion. PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.
Outcome measures
| Measure |
Schedule 1
n=3 Participants
LY3164530 in escalating dose cohorts of 300mg, 600mg, 1000mg and 1250mg given intravenously (IV) once on Days 1, 8, 15, and 22 of a 28-day cycle.
|
Schedule 2
n=3 Participants
LY3164530 in escalating dose cohorts of 500 mg or 600 mg given intravenously (IV) once on Days 1 and 15 of a 28-day cycle.
|
1000 mg LY3164530 Schedule 1
n=11 Participants
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
1250 mg LY3164530 Schedule 1
n=3 Participants
1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
500 mg LY3164530 Schedule 2
n=5 Participants
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
600 mg LY3164530 Schedule 2
n=4 Participants
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of LY3164530 Epidermal Growth Factor Receptor (EGFR) Specific ELISA Assay
Schedule 1 Cycle 1 Day 1; Schedule 2 Cycle 1 Day 1
|
85.1 microgram per milliliter (µg/mL )
Geometric Coefficient of Variation 38
|
122 microgram per milliliter (µg/mL )
Geometric Coefficient of Variation 12
|
367 microgram per milliliter (µg/mL )
Geometric Coefficient of Variation 52
|
496 microgram per milliliter (µg/mL )
Geometric Coefficient of Variation 30
|
226 microgram per milliliter (µg/mL )
Geometric Coefficient of Variation 20
|
255 microgram per milliliter (µg/mL )
Geometric Coefficient of Variation 21
|
|
Maximum Serum Concentration (Cmax) of LY3164530 Epidermal Growth Factor Receptor (EGFR) Specific ELISA Assay
Schedule 1 Cycle 1 Day 15;Schedule 2 Cycle 1Day 22
|
NA microgram per milliliter (µg/mL )
Geometric Coefficient of Variation NA
Geometric mean and coefficient of variation (CV) not calculated for 2 participants; individual participants values reported: 119.55 and 66.36.
|
147 microgram per milliliter (µg/mL )
Geometric Coefficient of Variation 15
|
348 microgram per milliliter (µg/mL )
Geometric Coefficient of Variation 34
|
615 microgram per milliliter (µg/mL )
Geometric Coefficient of Variation 38
|
262 microgram per milliliter (µg/mL )
Geometric Coefficient of Variation 35
|
350 microgram per milliliter (µg/mL )
Geometric Coefficient of Variation 20
|
|
Maximum Serum Concentration (Cmax) of LY3164530 Epidermal Growth Factor Receptor (EGFR) Specific ELISA Assay
Schedule 1 Cycle 2 Day 1; Schedule 2 Cycle 2 Day 1
|
72.19 microgram per milliliter (µg/mL )
Geometric Coefficient of Variation NA
Coefficient of variation was not calculated for 1 participant.
|
NA microgram per milliliter (µg/mL )
Geometric Coefficient of Variation NA
Geometric mean and CV not calculated for 2 participants; individual participants values reported: 115.02 and 135.38.
|
357 microgram per milliliter (µg/mL )
Geometric Coefficient of Variation 35
|
468.9 microgram per milliliter (µg/mL )
Geometric Coefficient of Variation NA
Coefficient of variation was not calculated for 1 participant.
|
270 microgram per milliliter (µg/mL )
Geometric Coefficient of Variation 32
|
NA microgram per milliliter (µg/mL )
Geometric Coefficient of Variation NA
Geometric mean and CV not calculated for 2 participants; individual participants values reported: 547.9 and 431.2.
|
SECONDARY outcome
Timeframe: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)Population: All participants who received at least one dose of study drug and had evaluable PK data.
Cmax in Schedule 1 Cycles 1 and 2 and Schedule 2 Cycles 1 and 2 based on the MET-specific ELISA assay. Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion. PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.
Outcome measures
| Measure |
Schedule 1
n=3 Participants
LY3164530 in escalating dose cohorts of 300mg, 600mg, 1000mg and 1250mg given intravenously (IV) once on Days 1, 8, 15, and 22 of a 28-day cycle.
|
Schedule 2
n=3 Participants
LY3164530 in escalating dose cohorts of 500 mg or 600 mg given intravenously (IV) once on Days 1 and 15 of a 28-day cycle.
|
1000 mg LY3164530 Schedule 1
n=11 Participants
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
1250 mg LY3164530 Schedule 1
n=3 Participants
1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
500 mg LY3164530 Schedule 2
n=5 Participants
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
600 mg LY3164530 Schedule 2
n=4 Participants
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of LY3164530 Mesenchymal-Epithelial Transition Factor (MET) Specific ELISA Assay
Schedule 1 Cycle 1 Day 1; Schedule 2 Cycle 1 Day 1
|
82.5 µg/mL
Geometric Coefficient of Variation 41
|
124 µg/mL
Geometric Coefficient of Variation 15
|
365 µg/mL
Geometric Coefficient of Variation 46
|
498 µg/mL
Geometric Coefficient of Variation 33
|
208 µg/mL
Geometric Coefficient of Variation 23
|
221 µg/mL
Geometric Coefficient of Variation 21
|
|
Maximum Serum Concentration (Cmax) of LY3164530 Mesenchymal-Epithelial Transition Factor (MET) Specific ELISA Assay
Schedule 1 Cycle 1 Day 15;Schedule 2 Cycle 1Day 22
|
NA µg/mL
Geometric Coefficient of Variation NA
Geometric mean and CV not calculated for 2 participants; individual values reported: 127.21 and 73.21.
|
136 µg/mL
Geometric Coefficient of Variation 12
|
346 µg/mL
Geometric Coefficient of Variation 33
|
587 µg/mL
Geometric Coefficient of Variation 35
|
260 µg/mL
Geometric Coefficient of Variation 32
|
317 µg/mL
Geometric Coefficient of Variation 17
|
|
Maximum Serum Concentration (Cmax) of LY3164530 Mesenchymal-Epithelial Transition Factor (MET) Specific ELISA Assay
Schedule 1 Cycle 2 Day 1; Schedule 2 Cycle 2 Day 1
|
72.32 µg/mL
Geometric Coefficient of Variation NA
The coefficient of variation was not calculated for 1 participant.
|
NA µg/mL
Geometric Coefficient of Variation NA
Geometric mean and CV not calculated for 2 participants; individual participants values reported:123.84 and 143.68.
|
353 µg/mL
Geometric Coefficient of Variation 27
|
400.9 µg/mL
Geometric Coefficient of Variation NA
The coefficient of variation was not calculated for 1 participant.
|
258 µg/mL
Geometric Coefficient of Variation 27
|
NA µg/mL
Geometric Coefficient of Variation NA
Geometric mean and CV not calculated for 2 participants; individual participants values reported: 541.5 and 347.0.
|
SECONDARY outcome
Timeframe: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)Population: All participants who received at least one dose of study drug and had evaluable PK data.
Area under the serum concentration-time curve of LY3164530 over the dosing interval (AUC\[0-τ\]) from time 0 to 336 hours (τ) \[Schedule 1\] or from time 0-168 hours (τ) \[Schedule 2\]. Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion. PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.
Outcome measures
| Measure |
Schedule 1
n=3 Participants
LY3164530 in escalating dose cohorts of 300mg, 600mg, 1000mg and 1250mg given intravenously (IV) once on Days 1, 8, 15, and 22 of a 28-day cycle.
|
Schedule 2
n=3 Participants
LY3164530 in escalating dose cohorts of 500 mg or 600 mg given intravenously (IV) once on Days 1 and 15 of a 28-day cycle.
|
1000 mg LY3164530 Schedule 1
n=11 Participants
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
1250 mg LY3164530 Schedule 1
n=3 Participants
1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
500 mg LY3164530 Schedule 2
n=5 Participants
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
600 mg LY3164530 Schedule 2
n=4 Participants
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 EGFR Specific ELISA Assay
Schedule 1 Cycle 1 Day 1; Schedule 2 Cycle 1 Day 1
|
5580 micrograms*milliliter per hour(µg*mL/hr)
Geometric Coefficient of Variation 28
|
9870 micrograms*milliliter per hour(µg*mL/hr)
Geometric Coefficient of Variation 23
|
37000 micrograms*milliliter per hour(µg*mL/hr)
Geometric Coefficient of Variation 42
|
57500 micrograms*milliliter per hour(µg*mL/hr)
Geometric Coefficient of Variation 28
|
16700 micrograms*milliliter per hour(µg*mL/hr)
Geometric Coefficient of Variation 37
|
19800 micrograms*milliliter per hour(µg*mL/hr)
Geometric Coefficient of Variation 21
|
|
Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 EGFR Specific ELISA Assay
Schedule 1 Cycle 1 Day 15;Schedule 2 Cycle 1 Day 2
|
NA micrograms*milliliter per hour(µg*mL/hr)
Geometric Coefficient of Variation NA
Geometric mean and CV not calculated for 2 participants; individual values reported: 13100 and 7170.
|
13700 micrograms*milliliter per hour(µg*mL/hr)
Geometric Coefficient of Variation 15
|
42700 micrograms*milliliter per hour(µg*mL/hr)
Geometric Coefficient of Variation 39
|
81400 micrograms*milliliter per hour(µg*mL/hr)
Geometric Coefficient of Variation 31
|
25500 micrograms*milliliter per hour(µg*mL/hr)
Geometric Coefficient of Variation 35
|
34900 micrograms*milliliter per hour(µg*mL/hr)
Geometric Coefficient of Variation 31
|
|
Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 EGFR Specific ELISA Assay
Schedule 1 Cycle 2 Day 1; Schedule 2 Cycle 2 Day 1
|
6690 micrograms*milliliter per hour(µg*mL/hr)
Geometric Coefficient of Variation NA
The coefficient of variation was not calculated for 1 participant.
|
NA micrograms*milliliter per hour(µg*mL/hr)
Geometric Coefficient of Variation NA
Geometric mean and CV not calculated for 2 participants; individual values reported: 12100 and 13300.
|
43000 micrograms*milliliter per hour(µg*mL/hr)
Geometric Coefficient of Variation 55
|
51500 micrograms*milliliter per hour(µg*mL/hr)
Geometric Coefficient of Variation NA
The coefficient of variation was not calculated for 1 participant.
|
26300 micrograms*milliliter per hour(µg*mL/hr)
Geometric Coefficient of Variation 35
|
NA micrograms*milliliter per hour(µg*mL/hr)
Geometric Coefficient of Variation NA
Geometric mean and CV not calculated for 2 participants; individual values reported: 31900 and 41300.
|
SECONDARY outcome
Timeframe: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)Population: All participants who received at least one dose of study drug and had evaluable PK data.
Area under the serum concentration-time curve of LY3164530 over the dosing interval (AUC\[0-τ\]) from time 0 to 336 hours (τ) \[Schedule 1\] or from time 0-168 hours (τ) \[Schedule 2\]. Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion. PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.
Outcome measures
| Measure |
Schedule 1
n=3 Participants
LY3164530 in escalating dose cohorts of 300mg, 600mg, 1000mg and 1250mg given intravenously (IV) once on Days 1, 8, 15, and 22 of a 28-day cycle.
|
Schedule 2
n=3 Participants
LY3164530 in escalating dose cohorts of 500 mg or 600 mg given intravenously (IV) once on Days 1 and 15 of a 28-day cycle.
|
1000 mg LY3164530 Schedule 1
n=11 Participants
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
1250 mg LY3164530 Schedule 1
n=3 Participants
1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
500 mg LY3164530 Schedule 2
n=5 Participants
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
600 mg LY3164530 Schedule 2
n=4 Participants
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 MET Specific ELISA Assay
Schedule 1 Cycle 2 Day 1; Schedule 2 Cycle 2 Day 1
|
6800 µg*hr/mL
Geometric Coefficient of Variation NA
The coefficient of variation was not calculated for 1 participant.
|
NA µg*hr/mL
Geometric Coefficient of Variation NA
Geometric mean and CV not calculated for 2 participants; individual values reported: 11800 and 13300.
|
44700 µg*hr/mL
Geometric Coefficient of Variation 45
|
46400 µg*hr/mL
Geometric Coefficient of Variation NA
The coefficient of variation was not calculated for 1 participant.
|
24800 µg*hr/mL
Geometric Coefficient of Variation 34
|
NA µg*hr/mL
Geometric Coefficient of Variation NA
Geometric mean and CV not calculated for 2 participants; individual values reported: 29500 and 36700.
|
|
Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 MET Specific ELISA Assay
Schedule 1 Cycle 1 Day 1; Schedule 2 Cycle 1 Day 1
|
6150 µg*hr/mL
Geometric Coefficient of Variation 26
|
10900 µg*hr/mL
Geometric Coefficient of Variation 27
|
37500 µg*hr/mL
Geometric Coefficient of Variation 41
|
57300 µg*hr/mL
Geometric Coefficient of Variation 31
|
16300 µg*hr/mL
Geometric Coefficient of Variation 22
|
17500 µg*hr/mL
Geometric Coefficient of Variation 20
|
|
Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 MET Specific ELISA Assay
Schedule 1 Cycle 1 Day 15;Schedule 2 Cycle 1 Day 2
|
NA µg*hr/mL
Geometric Coefficient of Variation NA
Geometric mean and CV not calculated for 2 participants; individual values reported: 12200 and 7260.
|
12900 µg*hr/mL
Geometric Coefficient of Variation 14
|
43000 µg*hr/mL
Geometric Coefficient of Variation 34
|
82000 µg*hr/mL
Geometric Coefficient of Variation 33
|
24800 µg*hr/mL
Geometric Coefficient of Variation 29
|
31200 µg*hr/mL
Geometric Coefficient of Variation 30
|
SECONDARY outcome
Timeframe: Baseline Through Study Completion (Up to 6 Months)Population: All participants who received at least one dose of study drug and had at least one post-baseline tumor assessment.
Number of Participants with Tumor Response
Outcome measures
| Measure |
Schedule 1
n=3 Participants
LY3164530 in escalating dose cohorts of 300mg, 600mg, 1000mg and 1250mg given intravenously (IV) once on Days 1, 8, 15, and 22 of a 28-day cycle.
|
Schedule 2
n=3 Participants
LY3164530 in escalating dose cohorts of 500 mg or 600 mg given intravenously (IV) once on Days 1 and 15 of a 28-day cycle.
|
1000 mg LY3164530 Schedule 1
n=9 Participants
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
1250 mg LY3164530 Schedule 1
n=3 Participants
1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
500 mg LY3164530 Schedule 2
n=5 Participants
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
600 mg LY3164530 Schedule 2
n=4 Participants
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Tumor Response
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Tumor Response
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Tumor Response
Stable Disease
|
1 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Tumor Response
Progressive Disease
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
300 mg LY3164530 Schedule 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
600 mg LY3164530 Schedule 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
1000 mg LY3164530 Schedule 1
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
1250 mg LY3164530 Schedule 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
500 mg LY3164530 Schedule 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
600 mg LY3164530 Schedule 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
300 mg LY3164530 Schedule 1
n=3 participants at risk
300 mg LY3164530 given intravenously (IV) on Days 1 and 15 of each 28 day cycle.
|
600 mg LY3164530 Schedule 1
n=3 participants at risk
600 mg LY3164530 given IV on Days 1, and 15 of each 28 day cycle.
|
1000 mg LY3164530 Schedule 1
n=11 participants at risk
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
1250 mg LY3164530 Schedule 1
n=3 participants at risk
1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
500 mg LY3164530 Schedule 2
n=5 participants at risk
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
600 mg LY3164530 Schedule 2
n=4 participants at risk
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Infections and infestations
Urosepsis
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
Other adverse events
| Measure |
300 mg LY3164530 Schedule 1
n=3 participants at risk
300 mg LY3164530 given intravenously (IV) on Days 1 and 15 of each 28 day cycle.
|
600 mg LY3164530 Schedule 1
n=3 participants at risk
600 mg LY3164530 given IV on Days 1, and 15 of each 28 day cycle.
|
1000 mg LY3164530 Schedule 1
n=11 participants at risk
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
1250 mg LY3164530 Schedule 1
n=3 participants at risk
1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
|
500 mg LY3164530 Schedule 2
n=5 participants at risk
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
600 mg LY3164530 Schedule 2
n=4 participants at risk
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
18.2%
2/11 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Eye disorders
Trichomegaly
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
27.3%
3/11 • Number of events 4 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 9 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
27.3%
3/11 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
40.0%
2/5 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Oral contusion
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
80.0%
4/5 • Number of events 6 • Baseline Through Study Completion (Up to 6 Months)
|
50.0%
2/4 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Tongue eruption
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
General disorders
Asthenia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
General disorders
Catheter site pruritus
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
General disorders
Chills
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
18.2%
2/11 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
27.3%
3/11 • Number of events 5 • Baseline Through Study Completion (Up to 6 Months)
|
66.7%
2/3 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
60.0%
3/5 • Number of events 7 • Baseline Through Study Completion (Up to 6 Months)
|
50.0%
2/4 • Number of events 15 • Baseline Through Study Completion (Up to 6 Months)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
General disorders
Nodule
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Number of events 4 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
36.4%
4/11 • Number of events 5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
40.0%
2/5 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
75.0%
3/4 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
18.2%
2/11 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
50.0%
2/4 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Infections and infestations
Nail infection
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
36.4%
4/11 • Number of events 4 • Baseline Through Study Completion (Up to 6 Months)
|
66.7%
2/3 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
40.0%
2/5 • Number of events 4 • Baseline Through Study Completion (Up to 6 Months)
|
50.0%
2/4 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Infections and infestations
Skin candida
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 4 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Number of events 4 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Injury, poisoning and procedural complications
Laceration
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
18.2%
2/11 • Number of events 5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
18.2%
2/11 • Number of events 4 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Investigations
Transaminases increased
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Investigations
Weight increased
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
27.3%
3/11 • Number of events 5 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
40.0%
2/5 • Number of events 5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
18.2%
2/11 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
27.3%
3/11 • Number of events 10 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
27.3%
3/11 • Number of events 8 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
60.0%
3/5 • Number of events 11 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
54.5%
6/11 • Number of events 26 • Baseline Through Study Completion (Up to 6 Months)
|
66.7%
2/3 • Number of events 7 • Baseline Through Study Completion (Up to 6 Months)
|
100.0%
5/5 • Number of events 17 • Baseline Through Study Completion (Up to 6 Months)
|
50.0%
2/4 • Number of events 4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
18.2%
2/11 • Number of events 6 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
18.2%
2/11 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
40.0%
2/5 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
50.0%
2/4 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
40.0%
2/5 • Number of events 7 • Baseline Through Study Completion (Up to 6 Months)
|
50.0%
2/4 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
18.2%
2/11 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
40.0%
2/5 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
40.0%
2/5 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
33.3%
1/3 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Nervous system disorders
Akathisia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Nervous system disorders
Ataxia
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
40.0%
2/5 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
18.2%
2/11 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Nervous system disorders
Horner's syndrome
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Nervous system disorders
Paraesthesia
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
40.0%
2/5 • Number of events 4 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
40.0%
2/5 • Number of events 4 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Renal and urinary disorders
Dysuria
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Reproductive system and breast disorders
Scrotal oedema
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
40.0%
2/5 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
66.7%
2/3 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
36.4%
4/11 • Number of events 4 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
50.0%
2/4 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal crusting
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal ulcer
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
66.7%
2/3 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
100.0%
3/3 • Number of events 7 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 4 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
18.2%
2/11 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
60.0%
3/5 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
50.0%
2/4 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
81.8%
9/11 • Number of events 27 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
80.0%
4/5 • Number of events 15 • Baseline Through Study Completion (Up to 6 Months)
|
75.0%
3/4 • Number of events 13 • Baseline Through Study Completion (Up to 6 Months)
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
33.3%
1/3 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
33.3%
1/3 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
80.0%
4/5 • Number of events 7 • Baseline Through Study Completion (Up to 6 Months)
|
25.0%
1/4 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
9.1%
1/11 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
40.0%
2/5 • Number of events 2 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Vascular disorders
Orthostatic hypotension
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
20.0%
1/5 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
|
Vascular disorders
Peripheral venous disease
|
33.3%
1/3 • Number of events 1 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/11 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/3 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/5 • Baseline Through Study Completion (Up to 6 Months)
|
0.00%
0/4 • Baseline Through Study Completion (Up to 6 Months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60