Trial Outcomes & Findings for Phase 2 Trial of Enzastaurin in Prostate Cancer in Participants Who Have Had Hormonal and Chemotherapy (NCT NCT00428714)

Last Updated: 2020-11-25

Results Overview

Objective responders were defined as participants (pts) in Cohort 1 who met prostate-specific antigen (PSA) response criteria. PSA Complete response (CR) was defined as a decrease in PSA to an undetectable level (\<0.2 ng/mL) confirmed by a second value obtained at least 4 weeks apart and without clinical or radiographic evidence of disease. PSA Partial Response (PR) was defined as a decrease in PSA of \>=50% at any time during the study. The decline of \>=50% in PSA must be from a baseline value of \>5 ng/mL and must be confirmed by a second value obtained at least 4 weeks apart and without clinical or radiographic evidence of disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

73 participants

Primary outcome timeframe

Baseline to Measured Progressive Disease, Death, Unacceptable Toxicities, or Study Closure Whichever Occurred First (up to 56 weeks)

Results posted on

2020-11-25

Participant Flow

Table presents reason for treatment discontinuation.

Participant milestones

Participant milestones
Measure	Enzastaurin-Cohort 1 Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.	Enzastaurin-Cohort 2 Participants with progressed, metastatic prostate cancer who had received prior treatment with a docetaxel-containing agent. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
Overall Study STARTED	31	42
Overall Study Received at Least 1 Dose of Study Drug	31	42
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	31	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Enzastaurin-Cohort 1 Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.	Enzastaurin-Cohort 2 Participants with progressed, metastatic prostate cancer who had received prior treatment with a docetaxel-containing agent. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
Overall Study Progressive Disease	28	36
Overall Study Withdrawal by Subject	0	3
Overall Study Adverse Event	0	2
Overall Study Physician Decision	1	1
Overall Study Death due to Progressive Disease (PD)	1	0
Overall Study Death due to other then PD	1	0

Baseline Characteristics

Phase 2 Trial of Enzastaurin in Prostate Cancer in Participants Who Have Had Hormonal and Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enzastaurin-Cohort 1 n=31 Participants Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.	Enzastaurin-Cohort 2 n=42 Participants Participants with progressed, metastatic prostate cancer who had received prior treatment with a docetaxel-containing agent. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.	Total n=73 Participants Total of all reporting groups
Age, Continuous Age	72.2 Years STANDARD_DEVIATION 10.0 • n=5 Participants	69.9 Years STANDARD_DEVIATION 7.77 • n=7 Participants	70.88 Years STANDARD_DEVIATION 9.90 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	42 Participants n=7 Participants	73 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	27 Participants n=5 Participants	39 Participants n=7 Participants	66 Participants n=5 Participants
Race/Ethnicity, Customized African	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized East Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized West Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	31 Participants n=5 Participants	42 Participants n=7 Participants	73 Participants n=5 Participants
Eastern Cooperative Oncology Group Scale Performance Status (ECOG) 0	22 Participants n=5 Participants	14 Participants n=7 Participants	36 Participants n=5 Participants
Eastern Cooperative Oncology Group Scale Performance Status (ECOG) 1	9 Participants n=5 Participants	26 Participants n=7 Participants	35 Participants n=5 Participants
Eastern Cooperative Oncology Group Scale Performance Status (ECOG) 2	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Measured Progressive Disease, Death, Unacceptable Toxicities, or Study Closure Whichever Occurred First (up to 56 weeks)

Population: Participants in Cohort 1 with a valid baseline and at least one post-baseline PSA assessment.

Outcome measures

Outcome measures
Measure	Enzastaurin-Cohort 1 n=27 Participants Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
Cohort 1 - Number of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Response Rate)	1 Participants

PRIMARY outcome

Timeframe: baseline to first occurrence of tumor progression, skeletal event, symptomatic progression, or death (up to 31.3 weeks)

Population: Participants in Cohort 2 who received at least 1 dose of enzastaurin. Two participants were censored.

PFS was defined as the time from date of enrollment to first occurrence of (1) tumor progression (defined per Response Evaluation Criteria In Solid Tumors \[RECIST\]) for soft tissue lesions, and/or appearance of \>=2 new lesions on bone scan (confirmed \>=6 weeks later); (2) skeletal event (pathological bone fracture and/or need for palliative radiotherapy); (3) symptomatic progression (worsening of Eastern Cooperative Oncology Group (ECOG) performance status (PS) and/or weight loss \>10% from baseline and/or increase in analgesic consumption and pain); or (4) Death due to any cause. PFS was censored at date of last objective progression-free observation for participants who were still alive and had not progressed. Participants who took any subsequent systemic anticancer therapy prior to progression or death were censored at date of last objective progression-free disease assessment prior to the date of the subsequent systemic anticancer therapy.

Outcome measures

Outcome measures
Measure	Enzastaurin-Cohort 1 n=42 Participants Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
Cohort 2 - Progression-free Survival (PFS)-Overall	11.0 Weeks Interval 7.57 to 11.7

SECONDARY outcome

Timeframe: baseline to 3 months

Population: Participants Cohort 1 with a valid baseline and at least one post-baseline PSA assessment.

Number of participants exhibiting a PSA level decline from baseline of greater than or equal to 30% within the first 3 months of study.

Outcome measures

Outcome measures
Measure	Enzastaurin-Cohort 1 n=27 Participants Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
Cohort 1 - Number of Participants With a 3-month PSA Level Decline of Greater Than or Equal to 30%	1 participants

SECONDARY outcome

Timeframe: baseline, 2 months and 3 months

Population: Participants in Cohort 1 with a valid baseline and at least one post-baseline PSA measurement within the first 2 and 3 months of treatment, respectively.

PSA velocity is defined as the rate of change in the PSA level during the first 2 and 3 months of the study.

Outcome measures

Outcome measures
Measure	Enzastaurin-Cohort 1 n=27 Participants Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
Cohort 1 - PSA Velocity PSA Velocity at 2 months	0.10003 nanograms per milliliter per year Interval -1.608 to 0.5939
Cohort 1 - PSA Velocity PSA Velocity at 3 months	0.06289 nanograms per milliliter per year Interval -2.5093 to 0.51271

SECONDARY outcome

Timeframe: baseline to date of disease progression, death, unacceptable toxicities, or study closure whichever occurred first (up to 56 weeks)

Population: Participants in Cohort 1 with a valid baseline and at least one post-baseline PSA assessment. Two participants were censored.

Progression free survival (PFS) is defined as the time from the date of enrollment to the first occurrence of PSA progression or objective progression defined as development of radiographic evidence of metastatic disease irrespective of PSA value or death due to any cause. PSA progression is defined as (a) for participants in whom a 50% decline in PSA has not been achieved, this is defined as 25% increase over baseline or nadir whichever is lower and an increase in the absolute value of PSA level by 5 ng/mL that is confirmed by another value of PSA confirmed at least 4 weeks apart; (b) for participants in whom a 50% decline in PSA has been achieved, this is defined as 50% increase over the nadir and an increase in the absolute value of PSA level by 5 ng/mL that is confirmed by another PSA level at least 4 weeks apart.

Outcome measures

Outcome measures
Measure	Enzastaurin-Cohort 1 n=27 Participants Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
Cohort 1 - Progression-free Survival (PFS)-Overall	12 weeks Interval 4.0 to 56.0

SECONDARY outcome

Timeframe: time of response to progressive disease, death, unacceptable toxicities, or study closure whichever occurred first (up to 56 weeks)

Population: Participants in Cohort 1 with a CR or PR who had a valid baseline and at least one post-baseline PSA assessment.

Duration of response was the date of first objective assessment of CR or PR to the date of first progression or death due to any cause. Progression of disease defined as:1) PSA progression: (a) in whom a 50% decline in PSA has not been achieved, defined as 25% increase over baseline or nadir whichever is lower and an increase in the absolute value of PSA level by 5 ng/mL and confirmed by another PSA at least 4 weeks apart, (b) in whom a 50% decline in PSA has been achieved, defined as 50% increase over the nadir and an increase in the absolute value of PSA level by 5 ng/mL and confirmed by another PSA level at least 4 weeks apart. 2) Objective Progression defined as radiographic evidence of metastatic disease irrespective of PSA value or 3) death due to any cause. Duration of response was censored on the date of discontinuation or last assessment for those participants who were alive without progression.

Outcome measures

Outcome measures
Measure	Enzastaurin-Cohort 1 n=1 Participants Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
Cohort 1 - Duration of Response	27.9 weeks 95% confidence interval was not estimable as only one participant had response.

SECONDARY outcome

Timeframe: baseline to 3 months

Population: Participants in Cohort 2 with a valid baseline and at least one post-baseline PSA measurement within the first 3 months of treatment.

Number of participants exhibiting a PSA level decline from baseline of greater than or equal to 30% within the first 3 months of study.

Outcome measures

Outcome measures
Measure	Enzastaurin-Cohort 1 n=42 Participants Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
Cohort 2 - 3-month PSA Level Decline of Greater Than or Equal to 30%	0 participants

SECONDARY outcome

Timeframe: baseline, 2 months and 3 months

Population: Participants in Cohort 2 with a valid baseline and at least one post-baseline PSA measurement within the first 2 and 3 months of treatment, respectively.

PSA velocity is defined as the rate of change in the PSA level during the first 2 and 3 months of the study.

Outcome measures

Outcome measures
Measure	Enzastaurin-Cohort 1 n=40 Participants Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
Cohort 2 - PSA Velocity PSA Velocity at 2 months	0.30297 nanograms per milliliter per year Interval 0.13621 to 0.46972
Cohort 2 - PSA Velocity PSA Velocity at 3 months	0.26702 nanograms per milliliter per year Interval 0.1098 to 0.42423

SECONDARY outcome

Timeframe: baseline to first occurrence of tumor progression, skeletal event, symptomatic progression, or death (up to 31.3 months)

Population: Participants in Cohort 2 with a valid baseline and at least one post-baseline PSA assessment.

Objective responders in Cohort 2 met either CR or PR for composite criteria of PSA and RECIST. CR was defined as a decrease in PSA to an undetectable level (\<0.2 ng/mL) confirmed by a second value at least 4 weeks apart and without clinical or radiographic evidence of disease per RECIST and normalization of bone scan. Bone only disease CR is normalization of bone scan with achievement of a nondetectable PSA confirmed 4-weeks after initial undetectable PSA. PR was defined as a decrease from baseline by 50% in PSA at any time during the study and confirmed by a second value at least 4 weeks apart and having at least a 30% decrease in sum of longest diameter of target lesions per RECIST and stable or improved bone scan.

Outcome measures

Outcome measures
Measure	Enzastaurin-Cohort 1 n=42 Participants Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
Cohort 2 - Number of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Response Rate)	0 participants

SECONDARY outcome

Timeframe: 6 months and 12 months

Population: Participants in Cohort 2 who received at least 1 dose of enzastaurin. Two participants were censored.

Percentage of participants who did not meet the following criteria at 6 months and at 12 months: disease progression defined per RECIST for soft tissue lesions and/or the appearance of 2 or more new lesions on bone scan, or skeletal event (any pathological bone fracture, and/or need for palliative radiotherapy), or symptomatic progression (worsening ECOG performance status) and/or weight loss \>10% from baseline and/or increase in analgesic consumption and pain, or death due to any cause. PFS was censored at the date of the most recent assessment for those who were still alive at the time of analysis and did not have evidence of tumor progression. Participants who took any subsequent systemic anticancer therapy prior to progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the date of the subsequent systemic anticancer therapy. Percent=(number of participants meeting PFS criteria/number of randomized)x100.

Outcome measures

Outcome measures
Measure	Enzastaurin-Cohort 1 n=42 Participants Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
Cohort 2 - Percentage of Participants With Progression Free Survival (PFS) at 6 Months and 12 Months 6 month PFS rate	3.0 percentage of participants
Cohort 2 - Percentage of Participants With Progression Free Survival (PFS) at 6 Months and 12 Months 12 month PFS rate	0.0 percentage of participants

SECONDARY outcome

Timeframe: baseline to date of death from any cause (up to 69.6 weeks)

Population: Participants in Cohort 2 who received at least 1 dose of enzastaurin. Number of censored participants is 36.

Overall survival is the duration from enrollment to death. For participants who were alive, overall survival was censored at the last contact.

Outcome measures

Outcome measures
Measure	Enzastaurin-Cohort 1 n=42 Participants Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
Cohort 2 - Overall Survival	NA weeks Interval 7.3 to 69.6 Median was not defined due to high censoring rate (only 6 events).

SECONDARY outcome

Timeframe: time of response to first occurrence of tumor progression, skeletal event, symptomatic progression, or death (up to 31.3 months)

Population: Zero participants were analyzed. Duration of response was not evaluable, as there were no participants with CR or PR in Cohort 2.

Duration of response was the date of first objective assessment of CR or PR to the date of first progression or death due to any cause. Progression of disease defined as:1) PSA progression: (a) in whom a 50% decline in PSA has not been achieved, defined as 25% increase over baseline or nadir whichever is lower and an increase in the absolute value of PSA level by 5 ng/mL and confirmed by another PSA at least 4 weeks apart, (b) in whom a 50% decline in PSA has been achieved, defined as 50% increase over the nadir and an increase in the absolute value of PSA level by 5 ng/mL and confirmed by another PSA level at least 4 weeks apart. 2) Objective Progression defined as radiographic evidence of metastatic disease irrespective of PSA value. 3) death due to any cause. Duration of response was censored on the date of discontinuation or last assessment for those participants who were alive without progression.

Outcome measures

Outcome data not reported

Adverse Events

Enzastaurin-Cohort 1

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Enzastaurin-Cohort 2

Serious events: 12 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Enzastaurin-Cohort 1 n=31 participants at risk Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.	Enzastaurin-Cohort 2 n=42 participants at risk Participants with progressed, metastatic prostate cancer who had received prior treatment with a docetaxel-containing agent. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
Cardiac disorders Atrial fibrillation	3.2% 1/31 • Number of events 1	0.00% 0/42
Cardiac disorders Cardiac failure congestive	3.2% 1/31 • Number of events 1	0.00% 0/42
Gastrointestinal disorders Abdominal pain upper	0.00% 0/31	2.4% 1/42 • Number of events 1
Gastrointestinal disorders Colitis	0.00% 0/31	2.4% 1/42 • Number of events 1
Gastrointestinal disorders Constipation	0.00% 0/31	2.4% 1/42 • Number of events 1
Gastrointestinal disorders Diarrhoea	0.00% 0/31	2.4% 1/42 • Number of events 1
Gastrointestinal disorders Nausea	0.00% 0/31	2.4% 1/42 • Number of events 1
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/31	2.4% 1/42 • Number of events 1
Gastrointestinal disorders Vomiting	0.00% 0/31	4.8% 2/42 • Number of events 2
General disorders Fatigue	0.00% 0/31	2.4% 1/42 • Number of events 1
General disorders Oedema peripheral	0.00% 0/31	2.4% 1/42 • Number of events 1
General disorders Pyrexia	0.00% 0/31	2.4% 1/42 • Number of events 1
Infections and infestations Campylobacter infection	0.00% 0/31	2.4% 1/42 • Number of events 1
Infections and infestations Pneumonia	3.2% 1/31 • Number of events 1	0.00% 0/42
Investigations Blood creatine increased	0.00% 0/31	4.8% 2/42 • Number of events 2
Investigations Blood creatinine increased	0.00% 0/31	4.8% 2/42 • Number of events 2
Investigations International normalised ratio increased	0.00% 0/31	2.4% 1/42 • Number of events 1
Investigations Prothrombin time prolonged	0.00% 0/31	2.4% 1/42 • Number of events 1
Metabolism and nutrition disorders Dehydration	0.00% 0/31	4.8% 2/42 • Number of events 2
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/31	2.4% 1/42 • Number of events 1
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/31	2.4% 1/42 • Number of events 1
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/31	4.8% 2/42 • Number of events 2
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	3.2% 1/31 • Number of events 1	0.00% 0/42
Nervous system disorders Spinal cord compression	0.00% 0/31	4.8% 2/42 • Number of events 2
Renal and urinary disorders Bladder obstruction	0.00% 0/31	2.4% 1/42 • Number of events 1
Renal and urinary disorders Haematuria	0.00% 0/31	2.4% 1/42 • Number of events 1
Renal and urinary disorders Hydronephrosis	0.00% 0/31	2.4% 1/42 • Number of events 1
Renal and urinary disorders Micturition urgency	0.00% 0/31	2.4% 1/42 • Number of events 1
Renal and urinary disorders Renal failure	3.2% 1/31 • Number of events 1	0.00% 0/42
Respiratory, thoracic and mediastinal disorders Cough	3.2% 1/31 • Number of events 1	0.00% 0/42
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.2% 1/31 • Number of events 1	0.00% 0/42
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.2% 1/31 • Number of events 1	0.00% 0/42
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/31	2.4% 1/42 • Number of events 1
Vascular disorders Hypotension	0.00% 0/31	2.4% 1/42 • Number of events 1
Vascular disorders Urinary bladder haemorrhage	0.00% 0/31	2.4% 1/42 • Number of events 1

Other adverse events

Other adverse events
Measure	Enzastaurin-Cohort 1 n=31 participants at risk Chemo-naive participants who had androgen-independent prostate cancer with rising PSA levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.	Enzastaurin-Cohort 2 n=42 participants at risk Participants with progressed, metastatic prostate cancer who had received prior treatment with a docetaxel-containing agent. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
Blood and lymphatic system disorders Anaemia	9.7% 3/31 • Number of events 4	4.8% 2/42 • Number of events 2
Blood and lymphatic system disorders Lymphopenia	6.5% 2/31 • Number of events 3	2.4% 1/42 • Number of events 1
Gastrointestinal disorders Constipation	6.5% 2/31 • Number of events 2	14.3% 6/42 • Number of events 7
Gastrointestinal disorders Diarrhoea	29.0% 9/31 • Number of events 13	14.3% 6/42 • Number of events 7
Gastrointestinal disorders Dry mouth	9.7% 3/31 • Number of events 3	0.00% 0/42
Gastrointestinal disorders Flatulence	6.5% 2/31 • Number of events 2	2.4% 1/42 • Number of events 1
Gastrointestinal disorders Nausea	16.1% 5/31 • Number of events 5	31.0% 13/42 • Number of events 13
Gastrointestinal disorders Rectal haemorrhage	6.5% 2/31 • Number of events 2	2.4% 1/42 • Number of events 1
Gastrointestinal disorders Vomiting	0.00% 0/31	16.7% 7/42 • Number of events 7
General disorders Fatigue	38.7% 12/31 • Number of events 13	40.5% 17/42 • Number of events 18
General disorders Oedema	0.00% 0/31	14.3% 6/42 • Number of events 6
General disorders Oedema peripheral	12.9% 4/31 • Number of events 4	11.9% 5/42 • Number of events 6
General disorders Pain	6.5% 2/31 • Number of events 2	9.5% 4/42 • Number of events 4
General disorders Pyrexia	0.00% 0/31	9.5% 4/42 • Number of events 4
Infections and infestations Upper respiratory tract infection	6.5% 2/31 • Number of events 2	0.00% 0/42
Investigations Alanine aminotransferase increased	6.5% 2/31 • Number of events 2	2.4% 1/42 • Number of events 1
Investigations Aspartate aminotransferase increased	9.7% 3/31 • Number of events 3	4.8% 2/42 • Number of events 2
Investigations Blood creatinine increased	6.5% 2/31 • Number of events 2	7.1% 3/42 • Number of events 3
Investigations Haemoglobin decreased	0.00% 0/31	7.1% 3/42 • Number of events 3
Investigations Urine colour abnormal	35.5% 11/31 • Number of events 11	4.8% 2/42 • Number of events 2
Investigations Weight decreased	0.00% 0/31	16.7% 7/42 • Number of events 7
Metabolism and nutrition disorders Anorexia	0.00% 0/31	28.6% 12/42 • Number of events 14
Metabolism and nutrition disorders Decreased appetite	3.2% 1/31 • Number of events 1	9.5% 4/42 • Number of events 4
Metabolism and nutrition disorders Dehydration	0.00% 0/31	9.5% 4/42 • Number of events 4
Metabolism and nutrition disorders Hypocholesterolaemia	6.5% 2/31 • Number of events 2	0.00% 0/42
Musculoskeletal and connective tissue disorders Arthralgia	3.2% 1/31 • Number of events 1	11.9% 5/42 • Number of events 6
Musculoskeletal and connective tissue disorders Back pain	9.7% 3/31 • Number of events 3	16.7% 7/42 • Number of events 7
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/31	16.7% 7/42 • Number of events 8
Musculoskeletal and connective tissue disorders Muscle spasms	6.5% 2/31 • Number of events 2	0.00% 0/42
Musculoskeletal and connective tissue disorders Muscular weakness	6.5% 2/31 • Number of events 2	4.8% 2/42 • Number of events 2
Musculoskeletal and connective tissue disorders Pain in extremity	3.2% 1/31 • Number of events 1	21.4% 9/42 • Number of events 11
Nervous system disorders Headache	6.5% 2/31 • Number of events 2	2.4% 1/42 • Number of events 1
Psychiatric disorders Insomnia	12.9% 4/31 • Number of events 5	7.1% 3/42 • Number of events 3
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/31	9.5% 4/42 • Number of events 4
Respiratory, thoracic and mediastinal disorders Cough	6.5% 2/31 • Number of events 2	7.1% 3/42 • Number of events 3
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/31	7.1% 3/42 • Number of events 3
Vascular disorders Hot flush	3.2% 1/31 • Number of events 1	7.1% 3/42 • Number of events 3
Vascular disorders Hypertension	6.5% 2/31 • Number of events 2	2.4% 1/42 • Number of events 1

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60