Trial Outcomes & Findings for A Phase 1 Study of LY2874455 in Participants With Advanced Cancer (NCT NCT01212107)
NCT ID: NCT01212107
Last Updated: 2019-06-12
Results Overview
MTD was determined after the evaluation of Part A portion of the trial. Dose escalation proceeded at 1.3 times the preceding cohort once a Grade 3 non-laboratory toxicity or Grade 2 laboratory toxicity was noted in ≥ 1 participant until MTD was achieved. Doses up to 24 mg (48 mg/day) were evaluated in Part A. The effects at this dose and at 18 mg (36 mg/day) suggested that a reasonable number of participants might not tolerate LY2874455 for chronic administration at these dose levels because of the constellation of effects observed individually or in combination in participants at these dose levels. Therefore, the dose of 16 mg BID of LY2874455 (total dose 32 mg per day) was selected as the initial dose for Part B. Selection of the dose level was based on the tolerability of this dose and without specific toxicities identified.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
94 participants
Primary outcome timeframe
Baseline Up to 32 Weeks
Results posted on
2019-06-12
Participant Flow
A participant was defined as completer of the study after 2 cycles while a participant who discontinued was classified as a discontinuation prior to completing 2 cycles or a discontinuation after 2 cycles. Final disposition for the study is provided.
Participant milestones
| Measure |
Part A: 2 mg FGF Receptor QD
Part A: Dose escalation
2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle.
|
Part A: 4 mg FGF Receptor QD
Part A: Dose escalation
4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor QD
Part A: Dose escalation
10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor QD + Phosphate Binders
Part A: Dose escalation 10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle.
|
Part A: 8 mg FGF Receptor BID
Part A: Dose escalation
8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor BID
Part A: Dose escalation 10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 14 mg FGF Receptor BID
Part A: Dose escalation 14 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 18 mg FGF Receptor BID
Part A: Dose escalation
18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 24 mg FGF Receptor BID
Part A: Dose escalation
24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 18 mg FGF Receptor BID Extension
Part A: Dose escalation 18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 16 mg FGF Receptor BID
Part A: Dose escalation 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle
|
Part B: 16 mg FGF Receptor BID (NSCLS & Gastric Cancer)
Part B: Dose determined by part a dose escalation
16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
58
|
|
Overall Study
COMPLETED
|
2
|
2
|
3
|
3
|
2
|
2
|
3
|
2
|
1
|
1
|
2
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
0
|
1
|
1
|
0
|
1
|
2
|
2
|
1
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 1 Study of LY2874455 in Participants With Advanced Cancer
Baseline characteristics by cohort
| Measure |
Part A: 2 mg FGF Receptor QD
n=3 Participants
Part A: Dose escalation 2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle.
|
Part A: 4 mg FGF Receptor QD
n=3 Participants
Part A: Dose escalation 4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor QD
n=6 Participants
Part A: Dose escalation 10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor QD + Phosphate Binders
n=3 Participants
Part A: Dose escalation 10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle
|
Part A: 8 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation 8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle
|
Part A: 10 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation 10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 14 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation 14 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 18 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 24 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation 24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 18 mg FGF Receptor BID Extension
n=3 Participants
Part A: Dose escalation 18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 16 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle
|
Part B: 16 mg FGF Receptor BID (NSCLS & Gastric Cancer )
n=58 Participants
Part B: Dose determined by part a dose escalation 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
59.3 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
57.8 years
STANDARD_DEVIATION 18.1 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
65.7 years
STANDARD_DEVIATION 9.5 • n=21 Participants
|
52.0 years
STANDARD_DEVIATION 11.5 • n=8 Participants
|
56.7 years
STANDARD_DEVIATION 13.2 • n=8 Participants
|
44.3 years
STANDARD_DEVIATION 3.8 • n=24 Participants
|
55.7 years
STANDARD_DEVIATION 6.7 • n=42 Participants
|
52.0 years
STANDARD_DEVIATION 24.8 • n=42 Participants
|
62.7 years
STANDARD_DEVIATION 14.2 • n=42 Participants
|
58.3 years
STANDARD_DEVIATION 9.5 • n=42 Participants
|
57.7 years
STANDARD_DEVIATION 11.2 • n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
30 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
64 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
58 Participants
n=42 Participants
|
94 Participants
n=36 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
52 Participants
n=42 Participants
|
69 Participants
n=36 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
25 Participants
n=36 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
South Korea
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
51 Participants
n=42 Participants
|
67 Participants
n=36 Participants
|
|
Region of Enrollment
Australia
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
27 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline Up to 32 WeeksPopulation: All participants who received at least one dose of study drug in Part A.
MTD was determined after the evaluation of Part A portion of the trial. Dose escalation proceeded at 1.3 times the preceding cohort once a Grade 3 non-laboratory toxicity or Grade 2 laboratory toxicity was noted in ≥ 1 participant until MTD was achieved. Doses up to 24 mg (48 mg/day) were evaluated in Part A. The effects at this dose and at 18 mg (36 mg/day) suggested that a reasonable number of participants might not tolerate LY2874455 for chronic administration at these dose levels because of the constellation of effects observed individually or in combination in participants at these dose levels. Therefore, the dose of 16 mg BID of LY2874455 (total dose 32 mg per day) was selected as the initial dose for Part B. Selection of the dose level was based on the tolerability of this dose and without specific toxicities identified.
Outcome measures
| Measure |
Part A Participants
n=36 Participants
Part A: Dose escalation
Cohort 1: 2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle.
Cohort2: 4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
Cohort3: 10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
Cohort4: 10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle.
Cohort5: 8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle.
Cohort6: 10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort7: 14 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort8: 18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort9: 24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort10: 18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort11: 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 4 mg FGF Receptor QD
Part A: Dose escalation
4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor QD
Part A: Dose escalation
10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor QD + Phosphate Binders
Part A: Dose escalation
10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle.
|
Part A: 8 mg FGF Receptor BID
Part A: Dose escalation
8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor BID
Part A: Dose escalation
10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 14 mg FGF Receptor BID
Part A: Dose escalation
14 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 18 mg FGF Receptor BID
Part A: Dose escalation
18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 24 mg FGF Receptor BID
Part A: Dose escalation
24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 18 mg FGF Receptor BID Extension
Part A: Dose escalation
18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 16 mg FGF Receptor BID
Part A: Dose escalation
16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle
|
Part B: 16 mg FGF Receptor BID (NSCLS & Gastric Cancer)
Part B: Dose confirmation
16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Recommended Dose for Phase 2 Studies : Maximum Tolerated Dose (MTD)
|
16 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Up to 60 WeeksPopulation: All participants who received at least one dose of study drug.
Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Part A Participants
n=3 Participants
Part A: Dose escalation
Cohort 1: 2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle.
Cohort2: 4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
Cohort3: 10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
Cohort4: 10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle.
Cohort5: 8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle.
Cohort6: 10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort7: 14 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort8: 18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort9: 24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort10: 18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort11: 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 4 mg FGF Receptor QD
n=3 Participants
Part A: Dose escalation
4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor QD
n=6 Participants
Part A: Dose escalation
10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor QD + Phosphate Binders
n=3 Participants
Part A: Dose escalation
10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle.
|
Part A: 8 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation
8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation
10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 14 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation
14 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 18 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation
18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 24 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation
24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 18 mg FGF Receptor BID Extension
n=3 Participants
Part A: Dose escalation
18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 16 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation
16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle
|
Part B: 16 mg FGF Receptor BID (NSCLS & Gastric Cancer)
n=58 Participants
Part B: Dose confirmation
16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
|
3 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: BORR: Baseline Up to 60 Weeks ; ORR: Baseline Up to 60 WeeksPopulation: All participants who received at least one dose of study drug and who had CT Scan and progressed.
BORR is evaluated using response evaluation criteria in solid tumors (RECIST, version 1.1) criteria. Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Best overall response rate = (unconfirmed CR+ unconfirmed PR) / subjects in efficacy population. Objective response rate = (confirmed CR+ confirmed PR) / subjects in efficacy population.
Outcome measures
| Measure |
Part A Participants
n=3 Participants
Part A: Dose escalation
Cohort 1: 2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle.
Cohort2: 4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
Cohort3: 10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
Cohort4: 10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle.
Cohort5: 8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle.
Cohort6: 10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort7: 14 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort8: 18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort9: 24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort10: 18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort11: 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 4 mg FGF Receptor QD
n=3 Participants
Part A: Dose escalation
4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor QD
n=6 Participants
Part A: Dose escalation
10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor QD + Phosphate Binders
n=3 Participants
Part A: Dose escalation
10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle.
|
Part A: 8 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation
8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation
10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 14 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation
14 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 18 mg FGF Receptor BID
n=2 Participants
Part A: Dose escalation
18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 24 mg FGF Receptor BID
n=2 Participants
Part A: Dose escalation
24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 18 mg FGF Receptor BID Extension
n=3 Participants
Part A: Dose escalation
18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 16 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation
16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle
|
Part B: 16 mg FGF Receptor BID (NSCLS & Gastric Cancer)
n=53 Participants
Part B: Dose confirmation
16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Best Overall Response Rate (BORR) and Objective Response Rate (ORR)
Best Overall Response Rate
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With Best Overall Response Rate (BORR) and Objective Response Rate (ORR)
Objective Response Rate
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Part A and B: Cycle 1, Day 1, Pre-Dose, 0.5 Hr (H), 1 H, 2 H, 4H,8 H,12 H,24 H; Day 28, Pre-Dose, 0.5 H, 1 H, 2 H, 4 H, 8 HPopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Maximum observed concentration during a dosing interval.
Outcome measures
| Measure |
Part A Participants
n=3 Participants
Part A: Dose escalation
Cohort 1: 2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle.
Cohort2: 4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
Cohort3: 10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
Cohort4: 10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle.
Cohort5: 8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle.
Cohort6: 10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort7: 14 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort8: 18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort9: 24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort10: 18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort11: 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 4 mg FGF Receptor QD
n=3 Participants
Part A: Dose escalation
4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor QD
n=6 Participants
Part A: Dose escalation
10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor QD + Phosphate Binders
n=3 Participants
Part A: Dose escalation
10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle.
|
Part A: 8 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation
8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation
10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 14 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation
14 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 18 mg FGF Receptor BID
n=6 Participants
Part A: Dose escalation
18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 24 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation
24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 18 mg FGF Receptor BID Extension
n=3 Participants
Part A: Dose escalation
18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 16 mg FGF Receptor BID
n=27 Participants
Part A: Dose escalation
16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle
|
Part B: 16 mg FGF Receptor BID (NSCLS & Gastric Cancer)
n=31 Participants
Part B: Dose confirmation
16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY2874455
Day 28
|
5.97 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 66.3
|
17.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 55.9
|
32.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 23.0
|
36.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 205
|
43.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 15.2
|
63.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 10.3
|
58.3 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 12.2
|
88.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 26.7
|
127 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
n=1 only Geometric Mean available
|
50.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 167
|
79.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 44.9
|
99.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38.7
|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY2874455
Day 1
|
6.25 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 59.0
|
8.99 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 27.1
|
38.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40.3
|
91.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 15.1
|
27.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 17.1
|
35.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 52.1
|
64.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 26.9
|
59.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 76.3
|
107 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 19.6
|
29.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 75.6
|
63.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 52.2
|
57.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 61.7
|
SECONDARY outcome
Timeframe: Part A and B: Cycle 1, Day 1, Pre-Dose, 0.5 Hr (H), 1 H, 2 H, 4H,8 H,12 H,24 H; Day 28, Pre-Dose, 0.5 H, 1 H, 2 H, 4 H, 8 HPopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Area under the concentration-time curve from time 0 to the end of the dosing interval (e.g., BID) calculated by a combination of linear and logarithmic trapezoidal methods (linear-up/log-down method).
Outcome measures
| Measure |
Part A Participants
n=3 Participants
Part A: Dose escalation
Cohort 1: 2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle.
Cohort2: 4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
Cohort3: 10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
Cohort4: 10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle.
Cohort5: 8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle.
Cohort6: 10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort7: 14 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort8: 18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort9: 24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort10: 18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
Cohort11: 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 4 mg FGF Receptor QD
n=3 Participants
Part A: Dose escalation
4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor QD
n=6 Participants
Part A: Dose escalation
10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor QD + Phosphate Binders
n=2 Participants
Part A: Dose escalation
10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle.
|
Part A: 8 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation
8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation
10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 14 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation
14 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 18 mg FGF Receptor BID
n=6 Participants
Part A: Dose escalation
18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 24 mg FGF Receptor BID
n=3 Participants
Part A: Dose escalation
24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 18 mg FGF Receptor BID Extension
n=6 Participants
Part A: Dose escalation
18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 16 mg FGF Receptor BID
n=27 Participants
Part A: Dose escalation
16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle
|
Part B: 16 mg FGF Receptor BID (NSCLS & Gastric Cancer)
n=31 Participants
Part B: Dose confirmation
16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration vs Time Curve 0 to Tau ( AUC[0-t]) of LY2874455
Day 1
|
32.7 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 62.6
|
76.9 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 66.7
|
224 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 36.1
|
421 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 18.1
|
106 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 7.28
|
140 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 27.3
|
301 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 18.4
|
325 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 85.8
|
532 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 33.4
|
171 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 77.2
|
291 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 55.8
|
258 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 66.0
|
|
Pharmacokinetics (PK): Area Under the Concentration vs Time Curve 0 to Tau ( AUC[0-t]) of LY2874455
Day 28
|
31.1 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 92.1
|
89.7 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 27.8
|
202 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 13.4
|
427 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 11.1
|
229 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 13.2
|
301 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 38.2
|
566 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 9.83
|
589 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 24.8
|
500 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
n=1 only Geometric Mean calculable
|
381 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 133
|
511 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 64.9
|
578 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 47.3
|
Adverse Events
Part A: 2 mg FGF Receptor QD
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 4 mg FGF Receptor QD
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 10 mg FGF Receptor QD
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A: 10 mg FGF Receptor QD + Phosphate Binders
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 8 mg FGF Receptor BID
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 10 mg FGF Receptor BID
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 14 mg FGF Receptor BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 18 mg FGF Receptor BID
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 24 mg FGF Receptor BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 18 mg FGF Receptor BID Extension
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 16 mg FGF Receptor BID
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B: 16 mg FGF Receptor BID (NSCLS and Gastric Cancer)
Serious events: 18 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: 2 mg FGF Receptor QD
n=3 participants at risk
Part A: Dose escalation 2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle.
|
Part A: 4 mg FGF Receptor QD
n=3 participants at risk
Part A: Dose escalation 4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor QD
n=6 participants at risk
Part A: Dose escalation 10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor QD + Phosphate Binders
n=3 participants at risk
Part A: Dose escalation 10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle.
|
Part A: 8 mg FGF Receptor BID
n=3 participants at risk
Part A: Dose escalation 8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor BID
n=3 participants at risk
Part A: Dose escalation 10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 14 mg FGF Receptor BID
n=3 participants at risk
Part A: Dose escalation 14 FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 18 mg FGF Receptor BID
n=3 participants at risk
Part A: Dose escalation 18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 24 mg FGF Receptor BID
n=3 participants at risk
Part A: Dose escalation 24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 18 mg FGF Receptor BID Extension
n=3 participants at risk
Part A: Dose escalation 18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 16 mg FGF Receptor BID
n=3 participants at risk
Part A: Dose escalation 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part B: 16 mg FGF Receptor BID (NSCLS and Gastric Cancer)
n=58 participants at risk
Part B: Dose determined by part a dose escalation
16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Eye disorders
Keratoconjunctivitis sicca
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
2/58 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/58
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/58
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
3.4%
2/58 • Number of events 4
|
|
General disorders
Fatigue
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
6.9%
4/58 • Number of events 4
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
2/58 • Number of events 2
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/58
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
6.9%
4/58 • Number of events 4
|
|
Infections and infestations
Septic shock
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.2%
3/58 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Nervous system disorders
Viith nerve paralysis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/58
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
Other adverse events
| Measure |
Part A: 2 mg FGF Receptor QD
n=3 participants at risk
Part A: Dose escalation 2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle.
|
Part A: 4 mg FGF Receptor QD
n=3 participants at risk
Part A: Dose escalation 4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor QD
n=6 participants at risk
Part A: Dose escalation 10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor QD + Phosphate Binders
n=3 participants at risk
Part A: Dose escalation 10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle.
|
Part A: 8 mg FGF Receptor BID
n=3 participants at risk
Part A: Dose escalation 8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle.
|
Part A: 10 mg FGF Receptor BID
n=3 participants at risk
Part A: Dose escalation 10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 14 mg FGF Receptor BID
n=3 participants at risk
Part A: Dose escalation 14 FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 18 mg FGF Receptor BID
n=3 participants at risk
Part A: Dose escalation 18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 24 mg FGF Receptor BID
n=3 participants at risk
Part A: Dose escalation 24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 18 mg FGF Receptor BID Extension
n=3 participants at risk
Part A: Dose escalation 18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part A: 16 mg FGF Receptor BID
n=3 participants at risk
Part A: Dose escalation 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
Part B: 16 mg FGF Receptor BID (NSCLS and Gastric Cancer)
n=58 participants at risk
Part B: Dose determined by part a dose escalation
16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Corneal erosion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Eye disorders
Corneal lesion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
6.9%
4/58 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
100.0%
3/3 • Number of events 4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
27.6%
16/58 • Number of events 24
|
|
Eye disorders
Diplopia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Eye disorders
Dry eye
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.2%
3/58 • Number of events 7
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
8.6%
5/58 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
66.7%
2/3 • Number of events 3
|
66.7%
2/3 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
32.8%
19/58 • Number of events 38
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
8.6%
5/58 • Number of events 5
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
8.6%
5/58 • Number of events 7
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
2/58 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
2/58 • Number of events 2
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Eye disorders
Cataract
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
33.3%
1/3 • Number of events 2
|
100.0%
3/3 • Number of events 4
|
100.0%
3/3 • Number of events 5
|
66.7%
2/3 • Number of events 2
|
100.0%
3/3 • Number of events 13
|
66.7%
2/3 • Number of events 6
|
66.7%
2/3 • Number of events 3
|
66.7%
2/3 • Number of events 3
|
77.6%
45/58 • Number of events 106
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
22.4%
13/58 • Number of events 13
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
17.2%
10/58 • Number of events 17
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
2/58 • Number of events 5
|
|
Gastrointestinal disorders
Epigastric discomfort
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
3.4%
2/58 • Number of events 2
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 4
|
34.5%
20/58 • Number of events 26
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 7
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3 • Number of events 3
|
66.7%
2/3 • Number of events 4
|
33.3%
1/3 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 3
|
32.8%
19/58 • Number of events 45
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 3
|
25.9%
15/58 • Number of events 24
|
|
General disorders
Asthenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
12.1%
7/58 • Number of events 9
|
|
General disorders
Chest discomfort
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
3.4%
2/58 • Number of events 2
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 3
|
66.7%
2/3 • Number of events 3
|
100.0%
3/3 • Number of events 3
|
33.3%
1/3 • Number of events 4
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 4
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 2
|
58.6%
34/58 • Number of events 47
|
|
General disorders
Influenza like illness
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
8.6%
5/58 • Number of events 6
|
|
General disorders
Localised oedema
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 3
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 2
|
66.7%
2/3 • Number of events 5
|
0.00%
0/3
|
17.2%
10/58 • Number of events 19
|
|
General disorders
Nodule
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
General disorders
Oedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
General disorders
Oedema peripheral
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
8.6%
5/58 • Number of events 5
|
|
General disorders
Pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Hepatobiliary disorders
Hepatomegaly
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Nail infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Oral fungal infection
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Infections and infestations
Paronychia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
2/58 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3 • Number of events 3
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Purulence
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Viral infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 3
|
33.3%
1/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
41.4%
24/58 • Number of events 44
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 3
|
33.3%
1/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
36.2%
21/58 • Number of events 39
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
2/58 • Number of events 12
|
|
Investigations
Blood amylase increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.2%
3/58 • Number of events 3
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 3
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
6.9%
4/58 • Number of events 5
|
|
Investigations
Calcium phosphate product increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 2
|
|
Investigations
General physical condition abnormal
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Investigations
Lipase increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.2%
3/58 • Number of events 3
|
|
Investigations
Liver palpable subcostal
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
2/58 • Number of events 2
|
|
Investigations
Platelet count decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 2
|
|
Investigations
Weight decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
12.1%
7/58 • Number of events 8
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
70.7%
41/58 • Number of events 64
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
3.4%
2/58 • Number of events 2
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
5.2%
3/58 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
2/58 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
3/6 • Number of events 3
|
66.7%
2/3 • Number of events 2
|
100.0%
3/3 • Number of events 10
|
100.0%
3/3 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 4
|
66.7%
2/3 • Number of events 5
|
66.7%
2/3 • Number of events 2
|
66.7%
2/3 • Number of events 5
|
79.3%
46/58 • Number of events 106
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.2%
3/58 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 2
|
5.2%
3/58 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
2/58 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.2%
3/58 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
6.9%
4/58 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
6.9%
4/58 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
2/58 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
12.1%
7/58 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/58
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
2/58 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
8.6%
5/58 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
8.6%
5/58 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/58
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
10.3%
6/58 • Number of events 6
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/58
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
5.2%
3/58 • Number of events 3
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
8.6%
5/58 • Number of events 6
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.2%
3/58 • Number of events 3
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/58
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.2%
3/58 • Number of events 3
|
|
Psychiatric disorders
Panic attack
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
6.9%
4/58 • Number of events 4
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.2%
3/58 • Number of events 7
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/58
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
15.5%
9/58 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
8.6%
5/58 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
12.1%
7/58 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
5.2%
3/58 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.2%
3/58 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
8.6%
5/58 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
2/58 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
66.7%
2/3 • Number of events 3
|
29.3%
17/58 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.2%
3/58 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Nail bed disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Nail bed tenderness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
3.4%
2/58 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 3
|
0.00%
0/3
|
22.4%
13/58 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
3.4%
2/58 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
20.7%
12/58 • Number of events 28
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
6.9%
4/58 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
|
Vascular disorders
Hypertension
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
5.2%
3/58 • Number of events 3
|
|
Vascular disorders
Hypotension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
1.7%
1/58 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/58
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60