Trial Outcomes & Findings for A Study of Enzastaurin in Chinese Patients With Advanced and/or Metastatic Solid Tumors or Lymphoma (NCT NCT01432951)
NCT ID: NCT01432951
Last Updated: 2020-10-12
Results Overview
PK (AUCt,ss) of Enzastaurin, its metabolites (LSN326020, LSN485912, and LSN2406799), and total analyte in plasma (enzastaurin + LSN326020 + LSN485912 + LSN2406799) were reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Day 14: Predose and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dose
Results posted on
2020-10-12
Participant Flow
Participants who were considered to have completed the study who received at least 1 dose of study drug and from whom a valid assay result was obtained.
Participant milestones
| Measure |
Enzastaurin
Enzastaurin 500 mg, four 125-mg tablets was administered orally once daily for 14 days. Dosing is held for 3 days, and resumes on Day 18. Participants may continue receiving optional enzastaurin treatment for up to 30 days.
Safety Extension: Participants had the option to continue receiving enzastaurin treatment until disease progression or discontinuation criteria are met, as per the investigator's assessment.
|
|---|---|
|
Treatment Phase (Day 1 to 30)
STARTED
|
26
|
|
Treatment Phase (Day 1 to 30)
Received at Least One Dose of Study Drug
|
25
|
|
Treatment Phase (Day 1 to 30)
PK Sampling (no Dosing) Days 15-17
|
23
|
|
Treatment Phase (Day 1 to 30)
Progressive Disease
|
10
|
|
Treatment Phase (Day 1 to 30)
COMPLETED
|
25
|
|
Treatment Phase (Day 1 to 30)
NOT COMPLETED
|
1
|
|
Safety Extension Day 30 to End of Study
STARTED
|
15
|
|
Safety Extension Day 30 to End of Study
COMPLETED
|
15
|
|
Safety Extension Day 30 to End of Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Enzastaurin
Enzastaurin 500 mg, four 125-mg tablets was administered orally once daily for 14 days. Dosing is held for 3 days, and resumes on Day 18. Participants may continue receiving optional enzastaurin treatment for up to 30 days.
Safety Extension: Participants had the option to continue receiving enzastaurin treatment until disease progression or discontinuation criteria are met, as per the investigator's assessment.
|
|---|---|
|
Treatment Phase (Day 1 to 30)
Never Treated
|
1
|
Baseline Characteristics
A Study of Enzastaurin in Chinese Patients With Advanced and/or Metastatic Solid Tumors or Lymphoma
Baseline characteristics by cohort
| Measure |
Enzastaurin
n=26 Participants
Enzastaurin 500 mg, four 125-mg tablets was administered orally once daily for 14 days. Dosing is held for 3 days, and resumes on Day 18. Participants may continue receiving optional enzastaurin treatment for up to 30 days.
|
|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14: Predose and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dosePopulation: All participants who received at least one dose of study drug had evaluable PK data.
PK (AUCt,ss) of Enzastaurin, its metabolites (LSN326020, LSN485912, and LSN2406799), and total analyte in plasma (enzastaurin + LSN326020 + LSN485912 + LSN2406799) were reported.
Outcome measures
| Measure |
Enzastaurin
n=23 Participants
Enzastaurin 500 mg, four 125-mg tablets was administered orally once daily for 14 days. Dosing is held for 3 days, and resumes on Day 18. Participants may continue receiving optional enzastaurin treatment for up to 30 days.
|
|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration -Time Curve Over a Dosing Interval at Steady State (AUCt,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
Enzastaurin
|
29100 nanomole*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 128
|
|
Pharmacokinetics (PK): Area Under the Concentration -Time Curve Over a Dosing Interval at Steady State (AUCt,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
LSN326020
|
21800 nanomole*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 45.5
|
|
Pharmacokinetics (PK): Area Under the Concentration -Time Curve Over a Dosing Interval at Steady State (AUCt,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
LSN485912
|
6520 nanomole*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 145
|
|
Pharmacokinetics (PK): Area Under the Concentration -Time Curve Over a Dosing Interval at Steady State (AUCt,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
LSN2406799
|
2910 nanomole*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 103
|
|
Pharmacokinetics (PK): Area Under the Concentration -Time Curve Over a Dosing Interval at Steady State (AUCt,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
Total Analytes
|
63700 nanomole*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 86.1
|
PRIMARY outcome
Timeframe: Day 14: Predose and and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dosePopulation: All participants who received at least one dose of study drug had evaluable PK data.
PK (Cmax,ss) of Enzastaurin, its metabolites (LSN326020, LSN485912, and LSN2406799), and total analyte in plasma (enzastaurin + LSN326020 + LSN485912 + LSN2406799) were reported.
Outcome measures
| Measure |
Enzastaurin
n=23 Participants
Enzastaurin 500 mg, four 125-mg tablets was administered orally once daily for 14 days. Dosing is held for 3 days, and resumes on Day 18. Participants may continue receiving optional enzastaurin treatment for up to 30 days.
|
|---|---|
|
PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
Enzastaurin
|
2370 nanomole/liter (nmol/L)
Geometric Coefficient of Variation 112
|
|
PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
LSN326020
|
1070 nanomole/liter (nmol/L)
Geometric Coefficient of Variation 38.4
|
|
PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
LSN485912
|
385 nanomole/liter (nmol/L)
Geometric Coefficient of Variation 116
|
|
PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
LSN2406799
|
265 nanomole/liter (nmol/L)
Geometric Coefficient of Variation 89.8
|
|
PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
Total Analytes
|
4140 nanomole/liter (nmol/L)
Geometric Coefficient of Variation 81.5
|
PRIMARY outcome
Timeframe: Day 14: Predose and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dosePopulation: All participants who received at least one dose of study drug had evaluable PK data.
PK (tmax,ss) of Enzastaurin, its metabolites (LSN326020, LSN485912, and LSN2406799), and total analyte in plasma (enzastaurin + LSN326020 + LSN485912 + LSN2406799) were reported.
Outcome measures
| Measure |
Enzastaurin
n=23 Participants
Enzastaurin 500 mg, four 125-mg tablets was administered orally once daily for 14 days. Dosing is held for 3 days, and resumes on Day 18. Participants may continue receiving optional enzastaurin treatment for up to 30 days.
|
|---|---|
|
PK: Time of Maximal Plasma Concentration at Steady State (Tmax, ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
Enzastaurin
|
4.00 Hour (h)
Interval 2.0 to 8.17
|
|
PK: Time of Maximal Plasma Concentration at Steady State (Tmax, ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
LSN326020
|
5.97 Hour (h)
Interval 0.0 to 24.0
|
|
PK: Time of Maximal Plasma Concentration at Steady State (Tmax, ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
LSN485912
|
6.00 Hour (h)
Interval 0.0 to 24.0
|
|
PK: Time of Maximal Plasma Concentration at Steady State (Tmax, ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
LSN2406799
|
4.00 Hour (h)
Interval 2.0 to 8.17
|
|
PK: Time of Maximal Plasma Concentration at Steady State (Tmax, ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
Total Analytes
|
4.00 Hour (h)
Interval 2.0 to 8.17
|
PRIMARY outcome
Timeframe: Day 14: Predose and and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dosePopulation: All participants who received at least one dose of study drug had evaluable PK data.
PK (Cav,ss) of Enzastaurin, its metabolites (LSN326020, LSN485912, and LSN2406799), and total analyte in plasma (enzastaurin + LSN326020 + LSN485912 + LSN2406799) were reported.
Outcome measures
| Measure |
Enzastaurin
n=23 Participants
Enzastaurin 500 mg, four 125-mg tablets was administered orally once daily for 14 days. Dosing is held for 3 days, and resumes on Day 18. Participants may continue receiving optional enzastaurin treatment for up to 30 days.
|
|---|---|
|
PK: Average Concentration During a Dosing Interval at Steady State (Cav,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
Enzastaurin
|
1210 nmol/L
Geometric Coefficient of Variation 128
|
|
PK: Average Concentration During a Dosing Interval at Steady State (Cav,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
LSN326020
|
907 nmol/L
Geometric Coefficient of Variation 45.5
|
|
PK: Average Concentration During a Dosing Interval at Steady State (Cav,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
LSN485912
|
272 nmol/L
Geometric Coefficient of Variation 145
|
|
PK: Average Concentration During a Dosing Interval at Steady State (Cav,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
LSN2406799
|
121 nmol/L
Geometric Coefficient of Variation 103
|
|
PK: Average Concentration During a Dosing Interval at Steady State (Cav,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
Total Analytes
|
2650 nmol/L
Geometric Coefficient of Variation 86.1
|
PRIMARY outcome
Timeframe: Day 14: Predose and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dosePopulation: All participants who received at least one dose of study drug had evaluable PK data.
PK terminal elimination half-life of Enzastaurin, its metabolites (LSN326020, LSN485912, and LSN2406799), and total analyte in plasma (enzastaurin + LSN326020 + LSN485912 + LSN2406799) were reported.
Outcome measures
| Measure |
Enzastaurin
n=23 Participants
Enzastaurin 500 mg, four 125-mg tablets was administered orally once daily for 14 days. Dosing is held for 3 days, and resumes on Day 18. Participants may continue receiving optional enzastaurin treatment for up to 30 days.
|
|---|---|
|
PK: Terminal Elimination Half-Life of Enzastaurin, It's Metabolites and Total Analytes in Plasma
Enzastaurin
|
14.0 Hour (h)
Geometric Coefficient of Variation 54.0
|
|
PK: Terminal Elimination Half-Life of Enzastaurin, It's Metabolites and Total Analytes in Plasma
LSN326020
|
42.0 Hour (h)
Geometric Coefficient of Variation 42.2
|
|
PK: Terminal Elimination Half-Life of Enzastaurin, It's Metabolites and Total Analytes in Plasma
LSN485912
|
14.5 Hour (h)
Geometric Coefficient of Variation 51.7
|
|
PK: Terminal Elimination Half-Life of Enzastaurin, It's Metabolites and Total Analytes in Plasma
LSN2406799
|
15.4 Hour (h)
Geometric Coefficient of Variation 51.1
|
|
PK: Terminal Elimination Half-Life of Enzastaurin, It's Metabolites and Total Analytes in Plasma
Total Analytes
|
NA Hour (h)
Geometric Coefficient of Variation NA
Total analytes are not directly measured or reported.
|
Adverse Events
Enzastaurin
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Enzastaurin Safety Extension
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Enzastaurin
n=25 participants at risk
Enzastaurin 500 mg, four 125-mg tablets was administered orally once daily for 14 days. Dosing is held for 3 days, and resumes on Day 18. Participants may continue receiving optional enzastaurin treatment for up to 30 days.
|
Enzastaurin Safety Extension
n=15 participants at risk
Participants had the option to continue receiving enzastaurin 500 mg, orally once daily until disease progression or discontinuation criteria are met, as per the investigator's assessment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
8.0%
2/25 • Number of events 2 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
0.00%
0/15 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.0%
4/25 • Number of events 4 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
0.00%
0/15 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Cardiac disorders
Sinus tachycardia
|
4.0%
1/25 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Gastrointestinal disorders
Abdominal distension
|
4.0%
1/25 • Number of events 2 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
2/25 • Number of events 3 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
13.3%
2/15 • Number of events 4 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
2/25 • Number of events 3 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 2 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
General disorders
Fatigue
|
4.0%
1/25 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
General disorders
Oedema
|
4.0%
1/25 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
13.3%
2/15 • Number of events 2 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
General disorders
Pain
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Infections and infestations
Furuncle
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Infections and infestations
Lung infection
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
1/25 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
20.0%
3/15 • Number of events 5 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Investigations
Alanine aminotransferase increased
|
12.0%
3/25 • Number of events 3 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Investigations
Aspartate aminotransferase increased
|
8.0%
2/25 • Number of events 2 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Investigations
Blood albumin decreased
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
13.3%
2/15 • Number of events 2 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Investigations
Blood bilirubin
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Investigations
Blood follicle stimulating hormone
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Investigations
Blood luteinising hormone increased
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Investigations
Blood potassium decreased
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Investigations
Electrocardiogram qt prolonged
|
36.0%
9/25 • Number of events 11 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Investigations
Haemoglobin decreased
|
4.0%
1/25 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
26.7%
4/15 • Number of events 4 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Investigations
Lymphocyte count decreased
|
8.0%
2/25 • Number of events 2 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Investigations
Neutrophil count decreased
|
4.0%
1/25 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
13.3%
2/15 • Number of events 2 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Investigations
Platelet count decreased
|
4.0%
1/25 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Investigations
Protein total decreased
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Investigations
White blood cell count decreased
|
4.0%
1/25 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Investigations
White blood cell count increased
|
4.0%
1/25 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
1/25 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
13.3%
2/15 • Number of events 4 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Renal and urinary disorders
Chromaturia
|
12.0%
3/25 • Number of events 3 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
0.00%
0/15 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.0%
1/25 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/25 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 6 years and 1 month)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60