Trial Outcomes & Findings for A Study for Participants With Metastatic Renal Cell Carcinoma (NCT NCT00709995)
NCT ID: NCT00709995
Last Updated: 2019-09-30
Results Overview
Progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Randomization to Measured Progressive Disease (PD) (Up to 24 Months)
Results posted on
2019-09-30
Participant Flow
Part 1 completers finished 3 or more cycles and included those with progressive disease. Part 2 was not performed and was not activated due to sponsor broad decision to not pursue enzastaurin in solid tumors.
Participant milestones
| Measure |
Modified Regimen A (Cohort 1)
On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle.
Sunitinib 50 mg was administered orally, (QD) once daily, Days 1-28, then rest (no drug given) Days 29-42.
|
Regimen A (Cohort 2)
Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason.
Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
6
|
|
Overall Study
Progressive Disease
|
6
|
1
|
|
Overall Study
COMPLETED
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Modified Regimen A (Cohort 1)
On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle.
Sunitinib 50 mg was administered orally, (QD) once daily, Days 1-28, then rest (no drug given) Days 29-42.
|
Regimen A (Cohort 2)
Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason.
Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
A Study for Participants With Metastatic Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Modified Regimen A (Cohort 1)
n=11 Participants
On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42.
|
Regimen A (Cohort 2)
n=6 Participants
Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason.
Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 5.44 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 8.42 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 6.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to Measured Progressive Disease (PD) (Up to 24 Months)Population: Zero participants data were collected. Part 2 was not activated due to sponsor broad decision to not pursue Enzastaurin in solid tumors.
Progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to Death from Any Cause (Up to 24 Months)Population: Zero participant data were collected. Part 2 was not activated due to sponsor broad decision to not pursue Enzastaurin in solid tumors.
OS time was defined as the number of months between the date of randomization and the date of death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to the Date of Objective Progressive Disease or Date of Death due to Study Disease, whichever came first (Up to 24 Months)Population: Zero participant data were collected. Part 2 was not activated due to sponsor broad decision to not pursue Enzastaurin in solid tumors.
Time to tumor progression (TTP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to Study Completion (Up to 6 Cycles)Population: All randomized participants who received at least one dose of study drug.
Clinically significant events were defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.
Outcome measures
| Measure |
Enzastaurin + Sunitinib
n=11 Participants
Enzastaurin: Cycle 1, Day 1 loading dose 375 mg administered orally, (TID) three times a day, followed by Part 1 dose twice a day on Days 2-42 of 6-week cycle.
Sunitinib: 50 mg administered orally, once daily, on Days 1-28, then rest Days 29-42.
|
Sunitinib + Placebo
n=6 Participants
Sunitinib: 50 mg administered orally, once daily, Day 1-28, then rest Days 29-42.
Placebo: Cycle 1 Day 1 loading dose 3 tablets on Day 1, then 2 tablets daily, Days 2-42.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs) in Part 1
AEs
|
11 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs) in Part 1
SAEs
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 15: Predose, 2, 4, and 6 - 8 hours, Up to 12 Hours Post dosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Pharmacokinetics (PK) was assessed in participants to determine the area under the concentration time curve during one dosing interval at steady state (AUCτ,ss) of Enzastaurin, LSN326020 and total Analytes. τ equals 12 hours for Enzastaurin, LSN326020 and total Analytes.
Outcome measures
| Measure |
Enzastaurin + Sunitinib
n=11 Participants
Enzastaurin: Cycle 1, Day 1 loading dose 375 mg administered orally, (TID) three times a day, followed by Part 1 dose twice a day on Days 2-42 of 6-week cycle.
Sunitinib: 50 mg administered orally, once daily, on Days 1-28, then rest Days 29-42.
|
Sunitinib + Placebo
n=5 Participants
Sunitinib: 50 mg administered orally, once daily, Day 1-28, then rest Days 29-42.
Placebo: Cycle 1 Day 1 loading dose 3 tablets on Day 1, then 2 tablets daily, Days 2-42.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under Concentration Time Curve During One Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin + Metabolite (LSN326020) + Total Analytes in Part 1
Enzastaurin
|
12000 nanomole*hour/liter (nmol*hr/L)
Geometric Coefficient of Variation 144
|
22600 nanomole*hour/liter (nmol*hr/L)
Geometric Coefficient of Variation 91
|
|
Pharmacokinetics (PK): Area Under Concentration Time Curve During One Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin + Metabolite (LSN326020) + Total Analytes in Part 1
LSN326020
|
8820 nanomole*hour/liter (nmol*hr/L)
Geometric Coefficient of Variation 76
|
12200 nanomole*hour/liter (nmol*hr/L)
Geometric Coefficient of Variation 73
|
|
Pharmacokinetics (PK): Area Under Concentration Time Curve During One Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin + Metabolite (LSN326020) + Total Analytes in Part 1
Total Analytes
|
21400 nanomole*hour/liter (nmol*hr/L)
Geometric Coefficient of Variation 101
|
35200 nanomole*hour/liter (nmol*hr/L)
Geometric Coefficient of Variation 82
|
SECONDARY outcome
Timeframe: Cycle 1 Day 15: Predose, 2, 4, and 6 - 8 hours, Up to 12 Hours Post dosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK was assessed in participants to determine the maximum concentration at steady state (Cmax, ss) of Enzastaurin + LSN326020 + total analytes.
Outcome measures
| Measure |
Enzastaurin + Sunitinib
n=11 Participants
Enzastaurin: Cycle 1, Day 1 loading dose 375 mg administered orally, (TID) three times a day, followed by Part 1 dose twice a day on Days 2-42 of 6-week cycle.
Sunitinib: 50 mg administered orally, once daily, on Days 1-28, then rest Days 29-42.
|
Sunitinib + Placebo
n=5 Participants
Sunitinib: 50 mg administered orally, once daily, Day 1-28, then rest Days 29-42.
Placebo: Cycle 1 Day 1 loading dose 3 tablets on Day 1, then 2 tablets daily, Days 2-42.
|
|---|---|---|
|
PK: Maximum Concentration at Steady State (Cmax,ss) of Enzastaurin + LSN326020 + Total Analytes in Part 1
Enzastaurin
|
1310 nanomole/liter (nmol/L)
Geometric Coefficient of Variation 109
|
2650 nanomole/liter (nmol/L)
Geometric Coefficient of Variation 71
|
|
PK: Maximum Concentration at Steady State (Cmax,ss) of Enzastaurin + LSN326020 + Total Analytes in Part 1
LSN326020
|
816 nanomole/liter (nmol/L)
Geometric Coefficient of Variation 72
|
1140 nanomole/liter (nmol/L)
Geometric Coefficient of Variation 64
|
|
PK: Maximum Concentration at Steady State (Cmax,ss) of Enzastaurin + LSN326020 + Total Analytes in Part 1
Total Analytes
|
2130 nanomole/liter (nmol/L)
Geometric Coefficient of Variation 88
|
3740 nanomole/liter (nmol/L)
Geometric Coefficient of Variation 65
|
Adverse Events
Modified Regimen A (Cohort 1)
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Regimen A (Cohort 2)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Modified Regimen A (Cohort 1)
n=11 participants at risk
On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle.
Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42.
|
Regimen A (Cohort 2)
n=6 participants at risk
Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason
Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
General disorders
General physical health deterioration
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Vascular disorders
Thrombosis
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
Other adverse events
| Measure |
Modified Regimen A (Cohort 1)
n=11 participants at risk
On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle.
Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42.
|
Regimen A (Cohort 2)
n=6 participants at risk
Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason
Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
72.7%
8/11 • Number of events 33 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
66.7%
4/6 • Number of events 10 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Blood and lymphatic system disorders
Leukopenia
|
27.3%
3/11 • Number of events 4 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.1%
1/11 • Number of events 2 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Blood and lymphatic system disorders
Neutropenia
|
45.5%
5/11 • Number of events 7 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 87 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
81.8%
9/11 • Number of events 20 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
33.3%
2/6 • Number of events 32 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Cardiac disorders
Bradycardia
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Endocrine disorders
Hyperthyroidism
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Endocrine disorders
Hypothyroidism
|
27.3%
3/11 • Number of events 3 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Eye disorders
Eyelid oedema
|
18.2%
2/11 • Number of events 2 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Eye disorders
Lacrimation increased
|
18.2%
2/11 • Number of events 5 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.2%
2/11 • Number of events 2 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
66.7%
4/6 • Number of events 5 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Anal discomfort
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Anal inflammation
|
27.3%
3/11 • Number of events 3 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • Number of events 2 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Dental discomfort
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Diarrhoea
|
63.6%
7/11 • Number of events 14 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
83.3%
5/6 • Number of events 5 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Dyspepsia
|
27.3%
3/11 • Number of events 3 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Dysphagia
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 2 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Haematochezia
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
33.3%
2/6 • Number of events 2 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Nausea
|
36.4%
4/11 • Number of events 7 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
33.3%
2/6 • Number of events 3 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Proctalgia
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Stomatitis
|
54.5%
6/11 • Number of events 9 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 4 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Gastrointestinal disorders
Vomiting
|
27.3%
3/11 • Number of events 3 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
66.7%
4/6 • Number of events 8 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
General disorders
Asthenia
|
27.3%
3/11 • Number of events 5 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
General disorders
Chest pain
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
General disorders
Chills
|
18.2%
2/11 • Number of events 2 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
General disorders
Face oedema
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 5 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
General disorders
Fatigue
|
45.5%
5/11 • Number of events 5 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
50.0%
3/6 • Number of events 9 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
General disorders
General physical health deterioration
|
18.2%
2/11 • Number of events 2 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 2 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
General disorders
Influenza like illness
|
18.2%
2/11 • Number of events 2 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
General disorders
Malaise
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
General disorders
Mucosal inflammation
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
General disorders
Oedema
|
18.2%
2/11 • Number of events 2 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
General disorders
Oedema peripheral
|
36.4%
4/11 • Number of events 7 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
General disorders
Pyrexia
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Infections and infestations
Bronchitis
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Infections and infestations
Cystitis
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Infections and infestations
Laryngitis
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Infections and infestations
Pharyngitis
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Infections and infestations
Tooth infection
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Infections and infestations
Upper respiratory tract infection
|
18.2%
2/11 • Number of events 3 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
18.2%
2/11 • Number of events 2 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Injury, poisoning and procedural complications
Wound
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 13 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 60 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Investigations
Blood amylase increased
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Investigations
Blood bilirubin decreased
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
50.0%
3/6 • Number of events 22 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Investigations
Blood lactate dehydrogenase increased
|
9.1%
1/11 • Number of events 2 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Investigations
Blood sodium increased
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 31 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Investigations
Blood urea increased
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Investigations
C-reactive protein increased
|
9.1%
1/11 • Number of events 2 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Investigations
Vitamin b12 decreased
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Investigations
Weight decreased
|
36.4%
4/11 • Number of events 4 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Investigations
Weight increased
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Metabolism and nutrition disorders
Anorexia
|
36.4%
4/11 • Number of events 5 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 8 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
27.3%
3/11 • Number of events 7 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
33.3%
2/6 • Number of events 2 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
18.2%
2/11 • Number of events 2 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.1%
1/11 • Number of events 2 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
18.2%
2/11 • Number of events 3 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
33.3%
2/6 • Number of events 2 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.2%
2/11 • Number of events 3 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Nervous system disorders
Dysgeusia
|
36.4%
4/11 • Number of events 4 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Nervous system disorders
Paraesthesia
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Psychiatric disorders
Insomnia
|
27.3%
3/11 • Number of events 3 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Renal and urinary disorders
Haematuria
|
18.2%
2/11 • Number of events 3 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/11 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
18.2%
2/11 • Number of events 5 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
45.5%
5/11 • Number of events 7 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
33.3%
2/6 • Number of events 3 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Skin and subcutaneous tissue disorders
Urticaria localised
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
18.2%
2/11 • Number of events 4 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
16.7%
1/6 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Vascular disorders
Hypertension
|
36.4%
4/11 • Number of events 4 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
|
Vascular disorders
Hypotension
|
9.1%
1/11 • Number of events 1 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
0.00%
0/6 • From Baseline to Study Completion (Up to 123 Months)
All participants who received at least one dose of study drug in Part 1.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60