Trial Outcomes & Findings for A Study of LY2940680 in Japanese Participants With Advanced Cancers (NCT NCT01919398)
NCT ID: NCT01919398
Last Updated: 2019-09-11
Results Overview
DLT was defined as an AE during Cycle 1 that is possibly related to the study drug and meets any one of the following criteria based on NCI CTCAE,version 4.0): Grade(Gr) 3 nonhematological toxicity(tox) with exceptions for made for nausea(ns),vomiting(vm),constipation(cp),diarrhea(dr),fatigue(ft),anorexia(an),alopecia or electrolyte-abnormality(eab) that is manageable with appropriate care.If \>Gr 3 ns,vm,cp,dr,ft,an,or eab persists for\>2 days with maximal supportive intervention,the event was declared a DLT.Transient(≤5 days) Gr 3 liver enzyme elevations,without evidence of other hepatic injury.Gr 3 thrombocytopenia(throm) requiring platelet transfusion or Gr 4 throm.Gr 4 neutropenia of \>5 days duration.Febrile neutropenia(ANC\<1,000/mm3 with a single temperature(temp) of \>38.3 degrees C or a sustained temp of ≥38 degrees C for more than one hour).Tox requiring dose omissions of \>5 days or significant \& deemed by the primary investigator(PI) \& sponsor(sp) to be dose limiting .
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
Cycle 1 (28 Days)
Results posted on
2019-09-11
Participant Flow
Study completers were participants who were Dose-Limiting Toxicities (DLT) evaluable and discontinued the treatment due to any reason.
Participant milestones
| Measure |
Cohort 1: 100 mg LY2940680
Cohort 1: 100 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 2: 200 mg LY2940680
Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 3: 400 mg LY2940680
Cohort 3: 400 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
13
|
|
Overall Study
Received at Least One Dose of Study Drug
|
3
|
3
|
13
|
|
Overall Study
COMPLETED
|
3
|
3
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1: 100 mg LY2940680
Cohort 1: 100 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 2: 200 mg LY2940680
Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 3: 400 mg LY2940680
Cohort 3: 400 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
|---|---|---|---|
|
Overall Study
Progressive Disease
|
0
|
0
|
4
|
Baseline Characteristics
A Study of LY2940680 in Japanese Participants With Advanced Cancers
Baseline characteristics by cohort
| Measure |
Cohort 1: 100 mg LY2940680
n=3 Participants
Cohort 1: 100 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 2: 200 mg LY2940680
n=3 Participants
Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 3: 400 mg LY2940680
n=13 Participants
Cohort 3: 400 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 7.02 • n=5 Participants
|
72.0 years
STANDARD_DEVIATION 4.36 • n=7 Participants
|
60.7 years
STANDARD_DEVIATION 11.93 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 10.95 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
16 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
19 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
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
|
|
Region of Enrollment
Japan
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (28 Days)Population: All participants who received at least one dose of study drug.
DLT was defined as an AE during Cycle 1 that is possibly related to the study drug and meets any one of the following criteria based on NCI CTCAE,version 4.0): Grade(Gr) 3 nonhematological toxicity(tox) with exceptions for made for nausea(ns),vomiting(vm),constipation(cp),diarrhea(dr),fatigue(ft),anorexia(an),alopecia or electrolyte-abnormality(eab) that is manageable with appropriate care.If \>Gr 3 ns,vm,cp,dr,ft,an,or eab persists for\>2 days with maximal supportive intervention,the event was declared a DLT.Transient(≤5 days) Gr 3 liver enzyme elevations,without evidence of other hepatic injury.Gr 3 thrombocytopenia(throm) requiring platelet transfusion or Gr 4 throm.Gr 4 neutropenia of \>5 days duration.Febrile neutropenia(ANC\<1,000/mm3 with a single temperature(temp) of \>38.3 degrees C or a sustained temp of ≥38 degrees C for more than one hour).Tox requiring dose omissions of \>5 days or significant \& deemed by the primary investigator(PI) \& sponsor(sp) to be dose limiting .
Outcome measures
| Measure |
Cohort 1: 100 mg LY2940680
n=3 Participants
Cohort 1: 100 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 2: 200 mg LY2940680
n=3 Participants
Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 3: 400 mg LY2940680
n=13 Participants
Cohort 3: 400 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
|---|---|---|---|
|
Number of Participants With LY2940680 Dose-Limiting Toxicities (DLT)
|
0 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Cycle1 Day1: Predose, 0.5,1,2,4, 6, 8, 10-12 hours; Cycle 1 Day15: Predose, 0.5,1,2,4, 6, 8, 10-12 hoursPopulation: All participants who received at least one dose of study drug who had evaluable PK data.
Maximum Concentration (Cmax) of LY2940680 and a Major Metabolite of LY2940680 (LSN3185556).
Outcome measures
| Measure |
Cohort 1: 100 mg LY2940680
n=3 Participants
Cohort 1: 100 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 2: 200 mg LY2940680
n=3 Participants
Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 3: 400 mg LY2940680
n=13 Participants
Cohort 3: 400 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2940680 and a Major Metabolite of LY2940680 (LSN3185556)
LY2940680:Cycle 1 Day 1
|
0.841 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 8
|
1.81 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 5
|
3.84 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 29
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2940680 and a Major Metabolite of LY2940680 (LSN3185556)
LY2940680:Cycle 1 Day 15
|
1.41 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 51
|
3.10 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 21
|
9.08 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 40
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2940680 and a Major Metabolite of LY2940680 (LSN3185556)
LSN3185556:Cycle 1 Day 1
|
0.925 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 45
|
1.49 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 8
|
3.02 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 30
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2940680 and a Major Metabolite of LY2940680 (LSN3185556)
LSN3185556:Cycle 1 Day 15
|
2.12 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 84
|
4.10 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 22
|
13.7 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 50
|
SECONDARY outcome
Timeframe: Cycle1 Day1: Predose, 0.5,1,2,4, 6, 8, 10-12 hours; Cycle 1 Day15: Predose, 0.5,1,2,4, 6, 8, 10-12 hoursPopulation: All participants who received at least one dose of study drug who had evaluable PK data.
Pharmacokinetics (PK): Area Under the Concentration time Curve From 0 to 24 Hours (AUC\[0-24\]) of LY2940680 and a Major Metabolite of LSN3185556.
Outcome measures
| Measure |
Cohort 1: 100 mg LY2940680
n=3 Participants
Cohort 1: 100 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 2: 200 mg LY2940680
n=3 Participants
Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 3: 400 mg LY2940680
n=13 Participants
Cohort 3: 400 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Time Curve From 0 to 24 Hours (AUC[0-24]) of LY2940680 and a Major Metabolite of LSN3185556
LY2940680:Cycle 1 Day 1
|
7.96 microgram*hour per milliliter(µg*h/mL)
Geometric Coefficient of Variation 31
|
20.3 microgram*hour per milliliter(µg*h/mL)
Geometric Coefficient of Variation 22
|
43.1 microgram*hour per milliliter(µg*h/mL)
Geometric Coefficient of Variation 26
|
|
Pharmacokinetics (PK): Area Under the Concentration Time Curve From 0 to 24 Hours (AUC[0-24]) of LY2940680 and a Major Metabolite of LSN3185556
LY2940680:Cycle 1 Day 15
|
14.7 microgram*hour per milliliter(µg*h/mL)
Geometric Coefficient of Variation 78
|
42.9 microgram*hour per milliliter(µg*h/mL)
Geometric Coefficient of Variation 40
|
142 microgram*hour per milliliter(µg*h/mL)
Geometric Coefficient of Variation 61
|
|
Pharmacokinetics (PK): Area Under the Concentration Time Curve From 0 to 24 Hours (AUC[0-24]) of LY2940680 and a Major Metabolite of LSN3185556
LSN3185556:Cycle 1 Day 1
|
13.2 microgram*hour per milliliter(µg*h/mL)
Geometric Coefficient of Variation 48
|
24.6 microgram*hour per milliliter(µg*h/mL)
Geometric Coefficient of Variation 5
|
50.1 microgram*hour per milliliter(µg*h/mL)
Geometric Coefficient of Variation 30
|
|
Pharmacokinetics (PK): Area Under the Concentration Time Curve From 0 to 24 Hours (AUC[0-24]) of LY2940680 and a Major Metabolite of LSN3185556
LSN3185556:Cycle 1 Day 15
|
31.8 microgram*hour per milliliter(µg*h/mL)
Geometric Coefficient of Variation 126
|
79.7 microgram*hour per milliliter(µg*h/mL)
Geometric Coefficient of Variation 15
|
235 microgram*hour per milliliter(µg*h/mL)
Geometric Coefficient of Variation 48
|
SECONDARY outcome
Timeframe: Baseline Until Disease Progression or Death Due to Any Cause (Up to 29 Months)Population: All participants who received at least one dose of study drug.
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size (\<10 millimeter \[mm\] short axis). PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.
Outcome measures
| Measure |
Cohort 1: 100 mg LY2940680
n=3 Participants
Cohort 1: 100 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 2: 200 mg LY2940680
n=3 Participants
Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 3: 400 mg LY2940680
n=13 Participants
Cohort 3: 400 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
|---|---|---|---|
|
Number of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Day15Population: All participants who received at least one dose of study drug and evaluable PD data.
Percentage Change From Baseline in Gene Expression Level of Hedgehog (Hh) Regulated Genes (Gli1) in Skin.
Outcome measures
| Measure |
Cohort 1: 100 mg LY2940680
n=3 Participants
Cohort 1: 100 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 2: 200 mg LY2940680
n=2 Participants
Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 3: 400 mg LY2940680
n=10 Participants
Cohort 3: 400 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
|---|---|---|---|
|
Pharmacodynamic (PD): Percentage Change From Baseline in Gene Expression Level of Hedgehog (Hh) Regulated Genes (Gli1) in Skin
|
92.73 percentage change
Standard Deviation 0.928
|
89.24 percentage change
Standard Deviation 2.096
|
92.86 percentage change
Standard Deviation 8.053
|
Adverse Events
Cohort 1: 100 mg LY2940680
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: 200 mg LY2940680
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3: 400 mg LY2940680
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: 100 mg LY2940680
n=3 participants at risk
Cohort 1: 100 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 2: 200 mg LY2940680
n=3 participants at risk
Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 3: 400 mg LY2940680
n=13 participants at risk
Cohort 3: 400 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
Other adverse events
| Measure |
Cohort 1: 100 mg LY2940680
n=3 participants at risk
Cohort 1: 100 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 2: 200 mg LY2940680
n=3 participants at risk
Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Cohort 3: 400 mg LY2940680
n=13 participants at risk
Cohort 3: 400 mg LY2940680 administered orally once daily in 28-day cycles.
Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
38.5%
5/13 • Number of events 5 • Baseline to End of Study (Up To 2.45 Years)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 2 • Baseline to End of Study (Up To 2.45 Years)
|
|
Ear and labyrinth disorders
Tinnitus
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 2 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 2 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
15.4%
2/13 • Number of events 2 • Baseline to End of Study (Up To 2.45 Years)
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
69.2%
9/13 • Number of events 12 • Baseline to End of Study (Up To 2.45 Years)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 2 • Baseline to End of Study (Up To 2.45 Years)
|
53.8%
7/13 • Number of events 8 • Baseline to End of Study (Up To 2.45 Years)
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
76.9%
10/13 • Number of events 10 • Baseline to End of Study (Up To 2.45 Years)
|
|
General disorders
Malaise
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
General disorders
Oedema
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
15.4%
2/13 • Number of events 2 • Baseline to End of Study (Up To 2.45 Years)
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
23.1%
3/13 • Number of events 4 • Baseline to End of Study (Up To 2.45 Years)
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 3 • Baseline to End of Study (Up To 2.45 Years)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Investigations
Electrocardiogram t wave inversion
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Investigations
Haematocrit decreased
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Investigations
Mean cell haemoglobin concentration decreased
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
15.4%
2/13 • Number of events 3 • Baseline to End of Study (Up To 2.45 Years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
76.9%
10/13 • Number of events 12 • Baseline to End of Study (Up To 2.45 Years)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
23.1%
3/13 • Number of events 3 • Baseline to End of Study (Up To 2.45 Years)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
30.8%
4/13 • Number of events 4 • Baseline to End of Study (Up To 2.45 Years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
23.1%
3/13 • Number of events 3 • Baseline to End of Study (Up To 2.45 Years)
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Nervous system disorders
Dysgeusia
|
100.0%
3/3 • Number of events 3 • Baseline to End of Study (Up To 2.45 Years)
|
66.7%
2/3 • Number of events 2 • Baseline to End of Study (Up To 2.45 Years)
|
61.5%
8/13 • Number of events 8 • Baseline to End of Study (Up To 2.45 Years)
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 2 • Baseline to End of Study (Up To 2.45 Years)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
15.4%
2/13 • Number of events 2 • Baseline to End of Study (Up To 2.45 Years)
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
15.4%
2/13 • Number of events 2 • Baseline to End of Study (Up To 2.45 Years)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
66.7%
2/3 • Number of events 2 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Renal and urinary disorders
Hydronephrosis
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
15.4%
2/13 • Number of events 2 • Baseline to End of Study (Up To 2.45 Years)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
15.4%
2/13 • Number of events 2 • Baseline to End of Study (Up To 2.45 Years)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
66.7%
2/3 • Number of events 2 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 2 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 2 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
2/3 • Number of events 2 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/13 • Baseline to End of Study (Up To 2.45 Years)
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Baseline to End of Study (Up To 2.45 Years)
|
33.3%
1/3 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
7.7%
1/13 • Number of events 1 • Baseline to End of Study (Up To 2.45 Years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60