Trial Outcomes & Findings for A Dose-Escalation Study in Participants With Advanced Cancer (NCT NCT01524224)
NCT ID: NCT01524224
Last Updated: 2019-04-01
Results Overview
A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. An AE is summarized if the onset date is on or after the first dose of study drug and within 30 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
Baseline through End of Study (up to 51 months)
Results posted on
2019-04-01
Participant Flow
Participant milestones
| Measure |
2 mg LY2495655
2 milligrams (mg) LY2495655 2 milligrams (mg) every 2 weeks. Dose Escalation Phase
|
7 mg LY2495655
7 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
21 mg LY2495655
21 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
70 mg LY2495655
70 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
100 mg LY2495655
100 mg LY2495655 every 2 weeks. Dose Confirmation Phase
|
210 mg LY2495655
210 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
300 mg LY2495655
300 mg LY2495655 every 2 weeks. Dose Confirmation Phase
|
700 mg LY2495655
700 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
3
|
4
|
3
|
3
|
6
|
|
Overall Study
Received at Least One Dose of Study Drug
|
4
|
3
|
3
|
3
|
4
|
3
|
3
|
6
|
|
Overall Study
COMPLETED
|
1
|
2
|
1
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
2
|
2
|
4
|
2
|
3
|
6
|
Reasons for withdrawal
| Measure |
2 mg LY2495655
2 milligrams (mg) LY2495655 2 milligrams (mg) every 2 weeks. Dose Escalation Phase
|
7 mg LY2495655
7 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
21 mg LY2495655
21 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
70 mg LY2495655
70 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
100 mg LY2495655
100 mg LY2495655 every 2 weeks. Dose Confirmation Phase
|
210 mg LY2495655
210 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
300 mg LY2495655
300 mg LY2495655 every 2 weeks. Dose Confirmation Phase
|
700 mg LY2495655
700 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
1
|
0
|
2
|
1
|
2
|
1
|
1
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Dose-Escalation Study in Participants With Advanced Cancer
Baseline characteristics by cohort
| Measure |
2 mg LY2495655
n=4 Participants
2 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
7 mg LY2495655
n=3 Participants
7 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
21 mg LY2495655
n=3 Participants
21 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
70 mg LY2495655
n=3 Participants
70 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
100 mg LY2495655
n=4 Participants
100 mg LY2495655 every 2 weeks. Dose Confirmation Phase
|
210 mg LY2495655
n=3 Participants
210 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
300 mg LY2495655
n=3 Participants
300 mg LY2495655 every 2 weeks. Dose Confirmation Phase
|
700 mg LY2495655
n=6 Participants
700 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
75.0 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
78.1 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
75.9 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
67.1 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
62.9 years
STANDARD_DEVIATION 12.5 • n=21 Participants
|
78.8 years
STANDARD_DEVIATION 7.2 • n=8 Participants
|
70.7 years
STANDARD_DEVIATION 7.3 • n=8 Participants
|
67.9 years
STANDARD_DEVIATION 9.6 • n=24 Participants
|
71.4 years
STANDARD_DEVIATION 9.3 • n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
20 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
25 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
African
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 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
|
1 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
29 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline through End of Study (up to 51 months)Population: All participants who received at least one dose of study drug.
A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. An AE is summarized if the onset date is on or after the first dose of study drug and within 30 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.
Outcome measures
| Measure |
2 mg LY2495655
n=4 Participants
2 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
7 mg LY2495655
n=3 Participants
7 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
21 mg LY2495655
n=3 Participants
21 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
70 mg LY2495655
n=3 Participants
70 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
100 mg LY2495655
n=4 Participants
100 mg LY2495655 every 2 weeks. Dose Confirmation Phase
|
210 mg LY2495655
n=3 Participants
210 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
300 mg LY2495655
n=3 Participants
300 mg LY2495655 every 2 weeks. Dose Confirmation Phase
|
700 mg LY2495655
n=6 Participants
700 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Drug-related Adverse Events
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 and Cycle 4 Days 1 (pre-dose, end of infusion, 2hr, 6hr, 10-12hr after the infusion ends) and Day 2, 3, 5, 8Population: All participants who received at least one dose of study drug and had evaluable pharmacokinetic data. Confidence Interval calculated as predictive interval and summarized from simulated PK profiles in 1000 virtual participants for each dose using a population PK model for LY2495655.
AUC(0-336h) is the area under the drug concentration versus time curve within a dosing interval (0-336 hours). Due to the small number per cohort (participants dropping out) calculations of the accumulation factor of exposure for repeated every-other-week dosing were based on simulated area under the drug concentration versus time curve within a dosing interval (AUCτ) instead of observed values. The 90-percentage confidence interval was calculated as the predictive interval.
Outcome measures
| Measure |
2 mg LY2495655
n=4 Participants
2 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
7 mg LY2495655
n=3 Participants
7 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
21 mg LY2495655
n=3 Participants
21 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
70 mg LY2495655
n=3 Participants
70 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
100 mg LY2495655
n=3 Participants
100 mg LY2495655 every 2 weeks. Dose Confirmation Phase
|
210 mg LY2495655
n=3 Participants
210 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
300 mg LY2495655
n=3 Participants
300 mg LY2495655 every 2 weeks. Dose Confirmation Phase
|
700 mg LY2495655
n=3 Participants
700 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration-time Curve From Time 0 to 336 Hours (AUC[0-336]) of LY2495655
Cycle 4
|
0.622 micromolar*hr (µM*hr)
Interval 0.408 to 0.931
|
2.63 micromolar*hr (µM*hr)
Interval 1.63 to 4.05
|
10.0 micromolar*hr (µM*hr)
Interval 6.0 to 15.3
|
39.2 micromolar*hr (µM*hr)
Interval 23.1 to 61.0
|
57.6 micromolar*hr (µM*hr)
Interval 33.9 to 89.8
|
124 micromolar*hr (µM*hr)
Interval 73.4 to 195.0
|
179 micromolar*hr (µM*hr)
Interval 106.0 to 280.0
|
424 micromolar*hr (µM*hr)
Interval 252.0 to 660.0
|
|
Pharmacokinetics (PK): Area Under the Concentration-time Curve From Time 0 to 336 Hours (AUC[0-336]) of LY2495655
Cycle 1
|
0.426 micromolar*hr (µM*hr)
Interval 0.309 to 0.605
|
1.62 micromolar*hr (µM*hr)
Interval 1.18 to 2.35
|
5.36 micromolar*hr (µM*hr)
Interval 3.87 to 7.94
|
19.5 micromolar*hr (µM*hr)
Interval 13.8 to 28.7
|
28.2 micromolar*hr (µM*hr)
Interval 20.2 to 41.6
|
60.4 micromolar*hr (µM*hr)
Interval 43.2 to 89.4
|
86.8 micromolar*hr (µM*hr)
Interval 62.1 to 128.0
|
204 micromolar*hr (µM*hr)
Interval 146.0 to 302.0
|
SECONDARY outcome
Timeframe: Cycle 1 and Cycle 4 Days 1 (pre-dose, end of infusion, 2hr, 6hr, 10-12hr after the infusion ends) and Day 2, 3, 5, 8Population: All participants who received at least one dose of study drug and had evaluable pharmacokinetic data.
Outcome measures
| Measure |
2 mg LY2495655
n=4 Participants
2 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
7 mg LY2495655
n=3 Participants
7 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
21 mg LY2495655
n=3 Participants
21 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
70 mg LY2495655
n=3 Participants
70 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
100 mg LY2495655
n=3 Participants
100 mg LY2495655 every 2 weeks. Dose Confirmation Phase
|
210 mg LY2495655
n=3 Participants
210 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
300 mg LY2495655
n=3 Participants
300 mg LY2495655 every 2 weeks. Dose Confirmation Phase
|
700 mg LY2495655
n=3 Participants
700 mg LY2495655 every 2 weeks. Dose Escalation Phase
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY2495655
Cycle 1
|
6.58 nanomolar (nM)
Geometric Coefficient of Variation 7
|
11.5 nanomolar (nM)
Geometric Coefficient of Variation 12
|
38.3 nanomolar (nM)
Geometric Coefficient of Variation 20
|
101.0 nanomolar (nM)
Geometric Coefficient of Variation 12
|
754.0 nanomolar (nM)
Geometric Coefficient of Variation 37
|
221.0 nanomolar (nM)
Geometric Coefficient of Variation 8
|
1360.0 nanomolar (nM)
Geometric Coefficient of Variation 27
|
392.0 nanomolar (nM)
Geometric Coefficient of Variation 14
|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY2495655
Cycle 4
|
6.67 nanomolar (nM)
Geometric Coefficient of Variation NA
CV% not calculated when n=2. Individual parameter (7.74, 5.75).
|
12.6 nanomolar (nM)
Geometric Coefficient of Variation 9
|
60.2 nanomolar (nM)
Geometric Coefficient of Variation NA
CV% not calculated when n=2. Individual parameter (55.62, 65.11).
|
165.0 nanomolar (nM)
Geometric Coefficient of Variation 16
|
1020.0 nanomolar (nM)
Geometric Coefficient of Variation NA
CV% not calculated when n=2. Individual parameter (768.76, 1349.52).
|
307.0 nanomolar (nM)
Geometric Coefficient of Variation 24
|
2010.0 nanomolar (nM)
Geometric Coefficient of Variation 31
|
559.0 nanomolar (nM)
Geometric Coefficient of Variation 18
|
Adverse Events
2 mg LY2495655
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
7 mg LY2495655
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
21 mg LY2495655
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
70 mg LY2495655
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
100 mg LY2495655
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
210 mg LY2495655
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
300 mg LY2495655
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
700 mg LY2495655
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2 mg LY2495655
n=4 participants at risk
2 mg LY2495655 every 2 weeks. Dose Escalation Phase.
|
7 mg LY2495655
n=3 participants at risk
7 mg LY2495655 every 2 weeks. Dose Escalation Phase.
|
21 mg LY2495655
n=3 participants at risk
21 mg LY2495655 every 2 weeks. Dose Escalation Phase.
|
70 mg LY2495655
n=3 participants at risk
70 mg LY2495655 every 2 weeks. Dose Escalation Phase.
|
100 mg LY2495655
n=4 participants at risk
100 mg LY2495655 every 2 weeks. Dose Confirmation Phase.
|
210 mg LY2495655
n=3 participants at risk
210 mg LY2495655 every 2 weeks. Dose Escalation Phase.
|
300 mg LY2495655
n=3 participants at risk
300 mg LY2495655 every 2 weeks. Dose Confirmation Phase.
|
700 mg LY2495655
n=6 participants at risk
700 mg LY2495655 every 2 weeks. Dose Escalation Phase.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Endocrine disorders
Adrenal haemorrhage
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Infections and infestations
Liver abscess
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
|
Nervous system disorders
Viith nerve paralysis
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 3
|
0.00%
0/6
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
Other adverse events
| Measure |
2 mg LY2495655
n=4 participants at risk
2 mg LY2495655 every 2 weeks. Dose Escalation Phase.
|
7 mg LY2495655
n=3 participants at risk
7 mg LY2495655 every 2 weeks. Dose Escalation Phase.
|
21 mg LY2495655
n=3 participants at risk
21 mg LY2495655 every 2 weeks. Dose Escalation Phase.
|
70 mg LY2495655
n=3 participants at risk
70 mg LY2495655 every 2 weeks. Dose Escalation Phase.
|
100 mg LY2495655
n=4 participants at risk
100 mg LY2495655 every 2 weeks. Dose Confirmation Phase.
|
210 mg LY2495655
n=3 participants at risk
210 mg LY2495655 every 2 weeks. Dose Escalation Phase.
|
300 mg LY2495655
n=3 participants at risk
300 mg LY2495655 every 2 weeks. Dose Confirmation Phase.
|
700 mg LY2495655
n=6 participants at risk
700 mg LY2495655 every 2 weeks. Dose Escalation Phase.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Eye disorders
Eye swelling
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 7
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
50.0%
2/4 • Number of events 18
|
0.00%
0/3
|
33.3%
1/3 • Number of events 7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 4
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
General disorders
Asthenia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 31
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
|
General disorders
Chest pain
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 2
|
33.3%
1/3 • Number of events 3
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 10
|
75.0%
3/4 • Number of events 6
|
0.00%
0/3
|
66.7%
2/3 • Number of events 8
|
16.7%
1/6 • Number of events 5
|
|
General disorders
Malaise
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Nodule
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 13
|
33.3%
1/3 • Number of events 5
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
General disorders
Pain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
|
General disorders
Pyrexia
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/6
|
|
Infections and infestations
Candidiasis
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Infections and infestations
Fungal skin infection
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
|
Infections and infestations
Herpes zoster
|
25.0%
1/4 • Number of events 6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Infections and infestations
Influenza
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Infections and infestations
Tooth infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 5
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
2/4 • Number of events 3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 4
|
16.7%
1/6 • Number of events 2
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 4
|
33.3%
1/3 • Number of events 2
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 17
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
|
Investigations
Glucose urine present
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 19
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Investigations
Weight decreased
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
33.3%
1/3 • Number of events 6
|
0.00%
0/3
|
50.0%
2/4 • Number of events 6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
66.7%
2/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4
|
0.00%
0/3
|
66.7%
2/3 • Number of events 9
|
33.3%
1/3 • Number of events 23
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4
|
0.00%
0/3
|
66.7%
2/3 • Number of events 7
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 3
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 7
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 15
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 6
|
|
Nervous system disorders
Aphasia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 5
|
0.00%
0/3
|
0.00%
0/6
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 4
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 5
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 15
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 19
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Nervous system disorders
Syncope
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Nervous system disorders
Tremor
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 13
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 17
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Psychiatric disorders
Depression
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 18
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 8
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 19
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 6
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
2/4 • Number of events 3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 6
|
0.00%
0/6
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4
|
33.3%
1/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 5
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4
|
33.3%
1/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 13
|
|
Vascular disorders
Hypotension
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60