Trial Outcomes & Findings for Enzastaurin Before and Concomitant With Radiation, Followed by Enzastaurin in Participants With Newly Diagnosed Glioblastoma (NCT NCT00509821)
NCT ID: NCT00509821
Last Updated: 2019-04-05
Results Overview
PFS-6 is defined as the percentage of participants with PFS at 6 months from the date of diagnosis to the first date of objectively determined progressive disease (based on radiological assessment) or death from any cause. It is assumed that PFS follows an exponential distribution.Estimation using Kaplan-Meier technique.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2019-04-05
Participant Flow
Completers were defined as participants who had failure event(progressive disease, death), or were off treatment or censored due to study completion. Participants completed follow-up after receiving 1 dose of study drug and a post dose efficacy evaluation.
Participant milestones
| Measure |
Enzastaurin Once Daily (QD)
A loading dose of 1125 mg of enzastaurin administered orally (PO) on Day -7 (3 tablets of 125 mg, given 3 times daily (TID) followed by 500 mg once daily (QD)
|
Enzastaurin Twice Daily (BID)
A loading dose of 1125 mg of enzastaurin administered PO Day -7 (TID); the dose from Day -6 until study end was 500 mg, given in 2 daily PO (BID) doses of 250 mg
|
|---|---|---|
|
Study Period 1 (Induction)
STARTED
|
3
|
57
|
|
Study Period 1 (Induction)
Received at Least 1 Dose of Study Drug
|
3
|
57
|
|
Study Period 1 (Induction)
COMPLETED
|
3
|
53
|
|
Study Period 1 (Induction)
NOT COMPLETED
|
0
|
4
|
|
Study Period 2 (Radiation)
STARTED
|
3
|
53
|
|
Study Period 2 (Radiation)
COMPLETED
|
3
|
0
|
|
Study Period 2 (Radiation)
NOT COMPLETED
|
0
|
53
|
|
Study Period 3 (Maintenance)
STARTED
|
3
|
49
|
|
Study Period 3 (Maintenance)
COMPLETED
|
3
|
0
|
|
Study Period 3 (Maintenance)
NOT COMPLETED
|
0
|
49
|
|
Study Period 4 (Follow Up)
STARTED
|
2
|
50
|
|
Study Period 4 (Follow Up)
COMPLETED
|
2
|
50
|
|
Study Period 4 (Follow Up)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Enzastaurin Once Daily (QD)
A loading dose of 1125 mg of enzastaurin administered orally (PO) on Day -7 (3 tablets of 125 mg, given 3 times daily (TID) followed by 500 mg once daily (QD)
|
Enzastaurin Twice Daily (BID)
A loading dose of 1125 mg of enzastaurin administered PO Day -7 (TID); the dose from Day -6 until study end was 500 mg, given in 2 daily PO (BID) doses of 250 mg
|
|---|---|---|
|
Study Period 1 (Induction)
Death
|
0
|
1
|
|
Study Period 1 (Induction)
Adverse Event
|
0
|
2
|
|
Study Period 1 (Induction)
Progressive Disease
|
0
|
1
|
Baseline Characteristics
Data not collected as per protocol.
Baseline characteristics by cohort
| Measure |
Enzastaurin Once Daily (QD)
Enzastaurin given orally (PO) once daily (QD). 1125 mg loading dose D(-)7 then 500 mg PO,QD with concomitant radiotherapy.
|
Enzastaurin Twice Daily (BID)
n=57 Participants
Enzastaurin 1125 mg loading dose D(-)7 then 250 mg twice daily (BID) PO.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
—
|
55.6 years
STANDARD_DEVIATION 11.29 • n=7 Participants • Data not collected as per protocol.
|
55.6 years
STANDARD_DEVIATION 11.29 • n=5 Participants • Data not collected as per protocol.
|
|
Sex: Female, Male
Female
|
—
|
21 Participants
n=7 Participants • Data not collected as per protocol.
|
21 Participants
n=5 Participants • Data not collected as per protocol.
|
|
Sex: Female, Male
Male
|
—
|
36 Participants
n=7 Participants • Data not collected as per protocol.
|
36 Participants
n=5 Participants • Data not collected as per protocol.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
57 Participants
n=7 Participants • Data not collected as per protocol.
|
57 Participants
n=5 Participants • Data not collected as per protocol.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
0 Participants
n=7 Participants • Data not collected as per protocol.
|
0 Participants
n=5 Participants • Data not collected as per protocol.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants • Data not collected as per protocol.
|
0 Participants
n=5 Participants • Data not collected as per protocol.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=7 Participants • Data not collected as per protocol.
|
0 Participants
n=5 Participants • Data not collected as per protocol.
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants • Data not collected as per protocol.
|
0 Participants
n=5 Participants • Data not collected as per protocol.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants • Data not collected as per protocol.
|
0 Participants
n=5 Participants • Data not collected as per protocol.
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=7 Participants • Data not collected as per protocol.
|
0 Participants
n=5 Participants • Data not collected as per protocol.
|
|
Race (NIH/OMB)
White
|
—
|
57 Participants
n=7 Participants • Data not collected as per protocol.
|
57 Participants
n=5 Participants • Data not collected as per protocol.
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=7 Participants • Data not collected as per protocol.
|
0 Participants
n=5 Participants • Data not collected as per protocol.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants • Data not collected as per protocol.
|
0 Participants
n=5 Participants • Data not collected as per protocol.
|
|
Region of Enrollment
Germany
|
0 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: All participants in BID arm who received at least one dose of study drug, BID, 4 participants were censored. Enzastaurin QD participants data not collected, as per protocol.
PFS-6 is defined as the percentage of participants with PFS at 6 months from the date of diagnosis to the first date of objectively determined progressive disease (based on radiological assessment) or death from any cause. It is assumed that PFS follows an exponential distribution.Estimation using Kaplan-Meier technique.
Outcome measures
| Measure |
Enzastaurin Twice Daily (BID)
n=57 Participants
Enzastaurin 1125 mg loading dose D(-)7 then 250 mg twice daily (BID) PO.
|
|---|---|
|
Percentage of Participants With Progression Free Survival at 6 Months (PFS-6)
|
53.6 percentage of participants
Interval 39.8 to 65.6
|
SECONDARY outcome
Timeframe: Baseline to 1 and 2 yearPopulation: All participants in BID arm who received at least one dose of study drug, BID, 11 participants were censored. Enzastaurin QD participants data not collected, as per protocol.
Overall survival (OS) time is defined as the time from the date of diagnosis to the date of death from any cause. For participants who are still alive at the time of analysis, survival time will be censored at the last contact date. OS rate at 1 year (respectively 2 years) is determined using the OS times.
Outcome measures
| Measure |
Enzastaurin Twice Daily (BID)
n=57 Participants
Enzastaurin 1125 mg loading dose D(-)7 then 250 mg twice daily (BID) PO.
|
|---|---|
|
Percentage of Participants With Overall Survival at 1 and 2 Years After Surgery
1 year
|
63.0 percentage of participants
Interval 49.1 to 74.1
|
|
Percentage of Participants With Overall Survival at 1 and 2 Years After Surgery
2 year
|
27.0 percentage of participants
Interval 16.2 to 39.0
|
SECONDARY outcome
Timeframe: Baseline to 30 monthsPopulation: All participants in BID arm who received at least 1 dose of study drug. Enzastaurin QD participants data not collected, as per protocol.
Response rate is calculated as the number of participants with best response: complete response(CR: disappearance of all enhancing tumor on consecutive CT or magnetic resonance imaging (MRI) scans at least 1 month apart, off steroids, and neurologically stable or improved ) or partial response (PR:-50% reduction in size of enhancing tumor on consecutive CT or MRI scans at least 1 month apart, steroids stable or reduced, and neurologically stable or improved), divided by the number of participants treated, multiplied by 100. CR and PR were assessed according to the criteria defined by MacDonald et al. 1990. A CR or PR must be confirmed by a second assessment, performed ≥28 days after the first evidence of response.
Outcome measures
| Measure |
Enzastaurin Twice Daily (BID)
n=57 Participants
Enzastaurin 1125 mg loading dose D(-)7 then 250 mg twice daily (BID) PO.
|
|---|---|
|
Response Rate
|
7.0 percentage of participants
Interval 2.0 to 17.0
|
SECONDARY outcome
Timeframe: Baseline through Week 12 .Population: All participants in BID arm who received at least 1 dose of study drug and had evaluable data. Enzastaurin QD participants data not collected, as per protocol.
Mini Mental State Status questionnaire is 11 questions, total score can range from 0 to 30, with a higher score indicating better function and a negative change in baseline indicating decrease in cognitive function.
Outcome measures
| Measure |
Enzastaurin Twice Daily (BID)
n=56 Participants
Enzastaurin 1125 mg loading dose D(-)7 then 250 mg twice daily (BID) PO.
|
|---|---|
|
Change in Neurologic Status as Measured by Mini Mental Status Questionnaire, Total Score
|
28.3 units on a scale
Standard Deviation 4.86
|
Adverse Events
Induction Enzastaurin Once Daily (QD)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Induction Enzastaurin Twice Daily (BID)
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Radiation Enzastaurin Once Daily (QD)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Radiation Enzastaurin Twice Daily (BID)
Serious events: 16 serious events
Other events: 43 other events
Deaths: 0 deaths
Maintenance Enzastaurin Once Daily (QD)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Maintenance Enzastaurin Twice Daily (BID)
Serious events: 8 serious events
Other events: 28 other events
Deaths: 0 deaths
Enzastaurin Once Daily (QD) Entire Study
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Enzastaurin Twice Daily (BID) Entire Study
Serious events: 27 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction Enzastaurin Once Daily (QD)
n=3 participants at risk
A loading dose of 1125 mg of enzastaurin administered orally (PO) on Day -7 (3 tablets of 125 mg, given 3 times daily (TID) followed by 500 mg once daily (QD)
|
Induction Enzastaurin Twice Daily (BID)
n=57 participants at risk
A loading dose of 1125 mg of enzastaurin administered PO Day -7 (TID); the dose from Day -6 until study end was 500 mg, given in 2 daily PO (BID) doses of 250 mg
|
Radiation Enzastaurin Once Daily (QD)
n=3 participants at risk
Enzastaurin 500 mg administered PO QD.
|
Radiation Enzastaurin Twice Daily (BID)
n=53 participants at risk
Enzastaurin 500 mg administered PO BID.
|
Maintenance Enzastaurin Once Daily (QD)
n=3 participants at risk
Enzastaurin 500 mg administered PO, QD continued until progression or unacceptable adverse events (AEs)
|
Maintenance Enzastaurin Twice Daily (BID)
n=49 participants at risk
Enzastaurin 500 mg administered PO, BID continued until progression or unacceptable adverse events (AEs)
|
Enzastaurin Once Daily (QD) Entire Study
n=3 participants at risk
A safety follow-up performed after end of enzastaurin treatment for all participants who received at least 1 dose of study drug.
|
Enzastaurin Twice Daily (BID) Entire Study
n=57 participants at risk
A safety follow-up performed after end of enzastaurin treatment for all participants who received at least 1 dose of study drug.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.5%
2/57 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.5%
2/57 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
4.1%
2/49 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.3%
3/57 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
General disorders
Fatigue
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.8%
2/53 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.5%
2/57 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
General disorders
Impaired healing
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
General disorders
Soft tissue inflammation
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Infections and infestations
Cerebral aspergillosis
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Infections and infestations
Empyema
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Infections and infestations
Pneumocystis jirovecii infection
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.7%
3/53 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
7.0%
4/57 • Number of events 4 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.8%
2/53 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.3%
3/57 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
4.1%
2/49 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
7.0%
4/57 • Number of events 4 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.8%
2/53 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
8.2%
4/49 • Number of events 7 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
10.5%
6/57 • Number of events 9 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.5%
2/57 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.7%
3/53 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.3%
3/57 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
Other adverse events
| Measure |
Induction Enzastaurin Once Daily (QD)
n=3 participants at risk
A loading dose of 1125 mg of enzastaurin administered orally (PO) on Day -7 (3 tablets of 125 mg, given 3 times daily (TID) followed by 500 mg once daily (QD)
|
Induction Enzastaurin Twice Daily (BID)
n=57 participants at risk
A loading dose of 1125 mg of enzastaurin administered PO Day -7 (TID); the dose from Day -6 until study end was 500 mg, given in 2 daily PO (BID) doses of 250 mg
|
Radiation Enzastaurin Once Daily (QD)
n=3 participants at risk
Enzastaurin 500 mg administered PO QD.
|
Radiation Enzastaurin Twice Daily (BID)
n=53 participants at risk
Enzastaurin 500 mg administered PO BID.
|
Maintenance Enzastaurin Once Daily (QD)
n=3 participants at risk
Enzastaurin 500 mg administered PO, QD continued until progression or unacceptable adverse events (AEs)
|
Maintenance Enzastaurin Twice Daily (BID)
n=49 participants at risk
Enzastaurin 500 mg administered PO, BID continued until progression or unacceptable adverse events (AEs)
|
Enzastaurin Once Daily (QD) Entire Study
n=3 participants at risk
A safety follow-up performed after end of enzastaurin treatment for all participants who received at least 1 dose of study drug.
|
Enzastaurin Twice Daily (BID) Entire Study
n=57 participants at risk
A safety follow-up performed after end of enzastaurin treatment for all participants who received at least 1 dose of study drug.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.5%
2/57 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
7.5%
4/53 • Number of events 4 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
12.3%
7/57 • Number of events 9 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.7%
3/53 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
7.0%
4/57 • Number of events 4 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.8%
2/53 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.3%
3/57 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.7%
3/53 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
8.2%
4/49 • Number of events 4 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
14.0%
8/57 • Number of events 8 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
9.4%
5/53 • Number of events 5 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
8.2%
4/49 • Number of events 4 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
15.8%
9/57 • Number of events 11 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.8%
2/53 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
14.3%
7/49 • Number of events 7 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
15.8%
9/57 • Number of events 9 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
General disorders
Fatigue
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
7.0%
4/57 • Number of events 4 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
9.4%
5/53 • Number of events 5 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
6.1%
3/49 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
22.8%
13/57 • Number of events 13 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.8%
2/53 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.3%
3/57 • Number of events 5 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
4.1%
2/49 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.3%
3/57 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Infections and infestations
Gingivitis
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.8%
2/53 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
8.2%
4/49 • Number of events 10 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
100.0%
3/3 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
10.5%
6/57 • Number of events 13 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
4.1%
2/49 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.3%
3/57 • Number of events 4 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
7.5%
4/53 • Number of events 4 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
8.8%
5/57 • Number of events 5 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
4.1%
2/49 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.3%
3/57 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.8%
2/53 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
4.1%
2/49 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
7.0%
4/57 • Number of events 6 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.8%
2/53 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
4.1%
2/49 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
7.0%
4/57 • Number of events 4 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Investigations
Weight increased
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.5%
2/57 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.8%
2/53 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.3%
3/57 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.8%
2/53 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
4.1%
2/49 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
7.0%
4/57 • Number of events 5 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.5%
2/57 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.5%
2/57 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.7%
3/53 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
66.7%
2/3 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
10.5%
6/57 • Number of events 7 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
66.7%
2/3 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
18.9%
10/53 • Number of events 12 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
6.1%
3/49 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
66.7%
2/3 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
24.6%
14/57 • Number of events 20 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.8%
2/53 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.3%
3/57 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
12.2%
6/49 • Number of events 6 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
15.8%
9/57 • Number of events 9 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Nervous system disorders
Somnolence
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.8%
2/53 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.5%
2/57 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Psychiatric disorders
Agitation
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.8%
2/53 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.3%
3/57 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
6.1%
3/49 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.3%
3/57 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Renal and urinary disorders
Chromaturia
|
100.0%
3/3 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
15.8%
9/57 • Number of events 9 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
100.0%
3/3 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
19.3%
11/57 • Number of events 11 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.8%
2/53 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
4.1%
2/49 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
7.0%
4/57 • Number of events 4 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
100.0%
3/3 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
22.6%
12/53 • Number of events 12 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
100.0%
3/3 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
22.8%
13/57 • Number of events 13 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.7%
3/53 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
5.3%
3/57 • Number of events 3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
3.5%
2/57 • Number of events 2 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.9%
1/53 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/49 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/57 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/53 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
0.00%
0/3 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
2.0%
1/49 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
1.8%
1/57 • Number of events 1 • First dose of study drug through 4 years.
All participants who received at least 1 dose of enzastaurin, Follow-up was included in Entire Study Arm.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60