Trial Outcomes & Findings for A Study of Oral LY317615 in Relapsed or Refractory Diffuse Large B-Cell Lymphomas. (NCT NCT00042666)
NCT ID: NCT00042666
Last Updated: 2020-08-10
Results Overview
Clinical Response Rate in participants with DLBCL was calculated as (number of participants who were progression-free for at least two 28-day cycles \[clinical responder\]) divided by (total number of participants analyzed) multiplied by 100. Progression free survival (PFS) defined as the time from randomization to the first observation of disease progression or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) as 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
COMPLETED
PHASE2
55 participants
Randomization to measured progressive disease (PD) up to 34.3 months
2020-08-10
Participant Flow
Participant Flow is reporting participants who discontinued from study drug. Per the protocol, a participant completed the study if the planned duration of treatment (6 cycles) was completed in the absence of disease progression or other reasons for discontinuation.
Participant milestones
| Measure |
Enzastaurin
500 milligrams (mg) enzastaurin (LY317615) tablets were administered in the morning within 30 minutes following a meal for 28 days (1 cycle) to be continued for up to 6 cycles in the absence of disease progression.
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
55
|
|
Overall Study
Completed at Least 1 Cycle of Study Drug
|
42
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
54
|
Reasons for withdrawal
| Measure |
Enzastaurin
500 milligrams (mg) enzastaurin (LY317615) tablets were administered in the morning within 30 minutes following a meal for 28 days (1 cycle) to be continued for up to 6 cycles in the absence of disease progression.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
4
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Participant/Physician Perception
|
1
|
|
Overall Study
Progressive Disease
|
41
|
|
Overall Study
Other
|
4
|
Baseline Characteristics
A Study of Oral LY317615 in Relapsed or Refractory Diffuse Large B-Cell Lymphomas.
Baseline characteristics by cohort
| Measure |
Enzastaurin
n=55 Participants
500 mg enzastaurin (LY317615) tablets were administered in the morning within 30 minutes following a meal for 28 days (1 cycle) to be continued for up to 6 cycles in the absence of disease progression.
|
|---|---|
|
Age, Continuous
|
67.4 years
STANDARD_DEVIATION 11.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 Participants
n=5 Participants
|
|
PKCβ expression by IHC in DLBCL Tumors
PKCβ Negative
|
1 Participants
n=5 Participants
|
|
PKCβ expression by IHC in DLBCL Tumors
PKCβ +1
|
1 Participants
n=5 Participants
|
|
PKCβ expression by IHC in DLBCL Tumors
PKCβ +3
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to measured progressive disease (PD) up to 34.3 monthsPopulation: All randomized participants who remained on study for at least 1 cycle of treatment.
Clinical Response Rate in participants with DLBCL was calculated as (number of participants who were progression-free for at least two 28-day cycles \[clinical responder\]) divided by (total number of participants analyzed) multiplied by 100. Progression free survival (PFS) defined as the time from randomization to the first observation of disease progression or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) as 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Enzastaurin
n=42 Participants
500 mg enzastaurin (LY317615) tablets were administered in the morning within 30 minutes following a meal for 28 days (1 cycle) to be continued for up to 6 cycles in the absence of disease progression.
|
|---|---|
|
Percentage of Participants With Relapsed or Refractory DLBCL Who Are Progression-Free for at Least 2 Cycles (28-Day Cycles) After Receiving Enzastaurin (LY317615) (Clinical Response Rate)
|
21.8 percentage of participants
Interval 11.8 to 35.0
|
SECONDARY outcome
Timeframe: Randomization to measured PD or death up to 34.3 monthsPopulation: All randomized participants who received at least 1 dose of study drug.
Overall response rate was defined as best study response (CR or PR) using modified Southwest Oncology Group (SWOG) Response criteria. CR defined as the disappearance of detectable clinical and radiographic evidence of disease; regression of lymph nodes, nodal masses and spleen to normal size and absence of lymphoma in bone marrow infiltrate. PR was defined as a ≥50% decrease in the sum of the products of their diameters (SPD) in the 6 largest dominant nodes or nodal masses; no increase in size in the other nodes or liver or spleen; regression of nodes/lesions in organs by ≥50% in the SPD; or no new disease sites. The percentage participants was calculated as: (number of participants with CR or PR) divided by (number of participants qualified for tumor response analysis) multiplied by 100.
Outcome measures
| Measure |
Enzastaurin
n=55 Participants
500 mg enzastaurin (LY317615) tablets were administered in the morning within 30 minutes following a meal for 28 days (1 cycle) to be continued for up to 6 cycles in the absence of disease progression.
|
|---|---|
|
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate)
|
3.64 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization to PD or death due to any cause up to 34.3 monthsPopulation: All randomized participants who received at least 1 dose of study drug. Five (5) participants were censored.
PFS was defined as the time from randomization to the first observation of disease progression or death due to any cause. For participants not known to have died as of the data cut-off date and who did not have PD, PFS was censored at the date of last follow-up visit. Progression is determined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) as 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Enzastaurin
n=55 Participants
500 mg enzastaurin (LY317615) tablets were administered in the morning within 30 minutes following a meal for 28 days (1 cycle) to be continued for up to 6 cycles in the absence of disease progression.
|
|---|---|
|
Progression Free Survival (PFS)
|
1.51 months
Interval 1.02 to 1.74
|
SECONDARY outcome
Timeframe: Time of response to PD up to 34.3 monthsPopulation: Zero participants were analyzed.
Duration of CR or PR was defined as the time from first objective assessment to first time of disease progression or death from any cause using the modified SWOG Response criteria. CR defined as the disappearance of detectable clinical and radiographic evidence of disease, regression of lymph nodes, nodal masses and spleen to normal size and absence of lymphoma in bone marrow infiltrate. PR was defined as a ≥50% decrease in the SPD in the 6 largest dominant nodes or nodal masses, no increase in size in the other nodes, liver or spleen, regression of nodes/lesions in organs by ≥50% in the SPD, and no new disease sites. PD defined as \>50% increase in SPD of the dominant nodal/non-nodal sites or new lesions. For participants who died, the duration of response was censored at death. For participants still alive, duration of overall response was censored at the last visit or follow-up visit. DOR was not analyzed due to low number of responders (CR or PR).
Outcome measures
| Measure |
Enzastaurin
n=2 Participants
500 mg enzastaurin (LY317615) tablets were administered in the morning within 30 minutes following a meal for 28 days (1 cycle) to be continued for up to 6 cycles in the absence of disease progression.
|
|---|---|
|
Duration of Overall Response (DOR)
|
NA months
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Randomization to study completion [Baseline up to 37 cycles (28-day cycles, 34.3 months) and 30-day follow-up]Population: All randomized participants who received at least 1 dose of study drug.
Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs. Participants who died due to PD, AEs while on treatment or died during the 30-day post-treatment period are included. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Enzastaurin
n=55 Participants
500 mg enzastaurin (LY317615) tablets were administered in the morning within 30 minutes following a meal for 28 days (1 cycle) to be continued for up to 6 cycles in the absence of disease progression.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) or Who Died
Non-serious AEs
|
51 Participants
|
|
Number of Participants With Adverse Events (AEs) or Who Died
Serious AEs
|
21 Participants
|
|
Number of Participants With Adverse Events (AEs) or Who Died
Deaths Due to PD
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs) or Who Died
Deaths Due to AEs
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) or Who Died
Deaths in 30-day follow-up
|
11 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 predose, 1 to 4 hours postdose and Cycle 1 Day 28 predose and at least 1-hour postdose (28-day cycle)Population: All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate AUC0-24,ss.
AUC0-24,ss during 1 dosing interval at steady state for Enzastaurin and its metabolite LY326020.
Outcome measures
| Measure |
Enzastaurin
n=33 Participants
500 mg enzastaurin (LY317615) tablets were administered in the morning within 30 minutes following a meal for 28 days (1 cycle) to be continued for up to 6 cycles in the absence of disease progression.
|
|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Time Curve at Steady State for One Dosing Interval (AUC0-24,ss) of Enzastaurin and Its Metabolite LY326020
Enzastaurin
|
14800 nanomoles*hour per liter (nmol*h/L)
Geometric Coefficient of Variation 83.2
|
|
Pharmacokinetics (PK): Area Under the Concentration Time Curve at Steady State for One Dosing Interval (AUC0-24,ss) of Enzastaurin and Its Metabolite LY326020
LY326020
|
14200 nanomoles*hour per liter (nmol*h/L)
Geometric Coefficient of Variation 39.6
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants who had paired diagnositic and relapsed tumor assessed for PKCβ expression.
Protein expression was measured (cytoplasmic staining) using an IHC assay from a small subset of tumor tissue samples that were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system, where higher staining indicated a greater PKCβ expression.
Outcome measures
| Measure |
Enzastaurin
n=3 Participants
500 mg enzastaurin (LY317615) tablets were administered in the morning within 30 minutes following a meal for 28 days (1 cycle) to be continued for up to 6 cycles in the absence of disease progression.
|
|---|---|
|
PKCβ Expression by IHC in Readily Assessable DLBCL Tumors From Participants
2+ at Diagnosis and 2+ at Relapse
|
1 participants
|
|
PKCβ Expression by IHC in Readily Assessable DLBCL Tumors From Participants
0 at Diagnosis and 1+ at Relapse
|
1 participants
|
|
PKCβ Expression by IHC in Readily Assessable DLBCL Tumors From Participants
3+ and 0 at Diagnosis and 3+ at Relapse
|
1 participants
|
Adverse Events
Enzastaurin
Serious adverse events
| Measure |
Enzastaurin
n=55 participants at risk
500 mg enzastaurin tablets were administered in the morning within 30 minutes of a meal for 28 days (1 cycle) to be continued for up to 6 cycles in the absence of disease progression.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Cardiac disorders
Angina unstable
|
3.6%
2/55 • Number of events 2
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.5%
3/55 • Number of events 3
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Asthenia
|
3.6%
2/55 • Number of events 2
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Fatigue
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Oedema peripheral
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Pyrexia
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Clostridium difficile sepsis
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Herpes zoster
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Pneumonia
|
3.6%
2/55 • Number of events 2
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Pneumonia pneumococcal
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Septic shock
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Investigations
Blood creatinine increased
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.3%
4/55 • Number of events 4
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Nervous system disorders
Syncope
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Psychiatric disorders
Confusional state
|
3.6%
2/55 • Number of events 2
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Renal and urinary disorders
Azotaemia
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Renal and urinary disorders
Ureteric obstruction
|
3.6%
2/55 • Number of events 2
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Vascular disorders
Hypotension
|
1.8%
1/55 • Number of events 1
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
Other adverse events
| Measure |
Enzastaurin
n=55 participants at risk
500 mg enzastaurin tablets were administered in the morning within 30 minutes of a meal for 28 days (1 cycle) to be continued for up to 6 cycles in the absence of disease progression.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.3%
4/55 • Number of events 4
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
5/55 • Number of events 5
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
5/55 • Number of events 5
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.2%
10/55 • Number of events 12
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Flatulence
|
7.3%
4/55 • Number of events 4
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
27.3%
15/55 • Number of events 15
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
11/55 • Number of events 11
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Asthenia
|
9.1%
5/55 • Number of events 5
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Chills
|
9.1%
5/55 • Number of events 5
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Fatigue
|
32.7%
18/55 • Number of events 21
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Oedema
|
9.1%
5/55 • Number of events 5
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Oedema peripheral
|
23.6%
13/55 • Number of events 16
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
General disorders
Pyrexia
|
16.4%
9/55 • Number of events 9
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
4/55 • Number of events 7
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Infections and infestations
Urinary tract infection
|
5.5%
3/55 • Number of events 3
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Investigations
Blood creatinine increased
|
7.3%
4/55 • Number of events 4
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Investigations
Weight decreased
|
5.5%
3/55 • Number of events 3
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.4%
9/55 • Number of events 9
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.3%
4/55 • Number of events 4
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.5%
3/55 • Number of events 4
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.5%
3/55 • Number of events 3
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
3/55 • Number of events 7
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.9%
6/55 • Number of events 9
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.3%
4/55 • Number of events 7
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.3%
4/55 • Number of events 6
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Nervous system disorders
Dizziness
|
10.9%
6/55 • Number of events 6
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Nervous system disorders
Headache
|
5.5%
3/55 • Number of events 3
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.5%
3/55 • Number of events 3
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Psychiatric disorders
Anxiety
|
5.5%
3/55 • Number of events 3
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Psychiatric disorders
Insomnia
|
7.3%
4/55 • Number of events 4
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Renal and urinary disorders
Chromaturia
|
7.3%
4/55 • Number of events 4
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
11/55 • Number of events 15
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.4%
9/55 • Number of events 9
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
9.1%
5/55 • Number of events 5
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.3%
4/55 • Number of events 4
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
5.5%
3/55 • Number of events 3
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60