Trial Outcomes & Findings for A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread (NCT NCT02102490)

Last Updated: 2020-01-21

Results Overview

ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

132 participants

Primary outcome timeframe

From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)

Results posted on

2020-01-21

Participant Flow

In the Participant Flow, participants who completed were those who died due to any cause or were alive and on study at conclusion but off treatment.

Participant milestones

Participant milestones
Measure	Abemaciclib 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Overall Study STARTED	132
Overall Study Received at Least 1 Dose of Study Drug	132
Overall Study COMPLETED	125
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Abemaciclib 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Overall Study Death	6
Overall Study Lost to Follow-up	1

Baseline Characteristics

A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abemaciclib n=132 Participants 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Age, Continuous	59.13 Years STANDARD_DEVIATION 10.33 • n=39 Participants
Sex: Female, Male Female	132 Participants n=39 Participants
Sex: Female, Male Male	0 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	112 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	2 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	6 Participants n=39 Participants
Race (NIH/OMB) White	112 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=39 Participants
Region of Enrollment Belgium	28 Participants n=39 Participants
Region of Enrollment United States	70 Participants n=39 Participants
Region of Enrollment France	11 Participants n=39 Participants
Region of Enrollment Spain	23 Participants n=39 Participants

PRIMARY outcome

Timeframe: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)

Population: All enrolled participants who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Abemaciclib n=132 Participants 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])	19.7 Percentage of participants Interval 13.3 to 27.5

SECONDARY outcome

Timeframe: From Date of First Dose until Death Due to Any Cause (Up To 27 Months)

Population: All enrolled participants who received at least one dose of study drug. Censored participants: Abemaciclib=70.

OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.

Outcome measures

Outcome measures
Measure	Abemaciclib n=132 Participants 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Overall Survival (OS)	22.32 Months Interval 17.72 to The upper limit of the 95% confidence interval (CI) was not calculated due to the high censoring rate.

SECONDARY outcome

Timeframe: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)

Population: All enrolled participants who received at least one dose of study drug.

DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.

Outcome measures

Outcome measures
Measure	Abemaciclib n=132 Participants 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Duration of Response (DOR)	8.6 Months Interval 5.8 to 10.2

SECONDARY outcome

Timeframe: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)

Population: All enrolled participants who received at least one dose of study drug. Censored participants: Abemaciclib=35.

PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.

Outcome measures

Outcome measures
Measure	Abemaciclib n=132 Participants 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Progression Free Survival (PFS)	6.0 Months Interval 4.2 to 7.5

SECONDARY outcome

Timeframe: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)

Population: All enrolled participants who received at least one dose of study drug.

Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.

Outcome measures

Outcome measures
Measure	Abemaciclib n=132 Participants 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Percentage of Participants With CR, PR or SD (Disease Control Rate [DCR])	67.4 Percentage of participants Interval 58.7 to 75.3

SECONDARY outcome

Timeframe: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)

Population: All enrolled participants who received at least one dose of the study drug.

Clinical benefit rate defined as percentage of patients with best overall response of CR, PR, or SD with a duration of at least 6 months. CR, PR, or SD were defined using RECIST, v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) \*100.

Outcome measures

Outcome measures
Measure	Abemaciclib n=132 Participants 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Percentage of Participants With Tumor Response of Stable Disease (SD) for at Least 6 Months, Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate)	42.4 Percentage of participants Interval 33.9 to 51.3

SECONDARY outcome

Timeframe: Cycle 6 Day 1

Population: All randomized participants with a baseline and at least 1 post-baseline mBPI-sf data.

A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).

Outcome measures

Outcome measures
Measure	Abemaciclib n=59 Participants 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score Better	18 Participants
Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score No Change	21 Participants
Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score Worse	20 Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose

Population: All enrolled participants who received at least one dose of study drug (Abemaciclib) with evaluable Abemaciclib, M2 and M20 pharmacokinetic (PK) data.

Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) was evaluated for Abemaciclib and Metabolites M2 and M20

Outcome measures

Outcome measures
Measure	Abemaciclib n=132 Participants 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20 Abemaciclib	3510 Nanogramshour/milliliters (ngh/mL)] Geometric Coefficient of Variation 38.0
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20 M2	1620 Nanogramshour/milliliters (ngh/mL)] Geometric Coefficient of Variation 55.0
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20 M20	2750 Nanogramshour/milliliters (ngh/mL)] Geometric Coefficient of Variation 55.0

SECONDARY outcome

Timeframe: Cycle 6 Day 1

Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 data.

EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.

Outcome measures

Outcome measures
Measure	Abemaciclib n=59 Participants 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score Worse	26 Participants
Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score Better	17 Participants
Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score No Change	16 Participants

Adverse Events

Abemaciclib

Serious events: 33 serious events

Other events: 132 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Abemaciclib n=132 participants at risk 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Blood and lymphatic system disorders Febrile neutropenia	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Blood and lymphatic system disorders Haematotoxicity	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	0.76% 1/132 • Number of events 2 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Cardiac disorders Sinus bradycardia	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Cardiac disorders Tachycardia	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	1.5% 2/132 • Number of events 2 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Large intestinal obstruction	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	2.3% 3/132 • Number of events 3 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Pancreatic enzyme abnormality	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Varices oesophageal	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
General disorders Asthenia	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
General disorders Pyrexia	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Infections and infestations Atypical pneumonia	0.76% 1/132 • Number of events 2 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Infections and infestations Cellulitis	1.5% 2/132 • Number of events 5 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis viral	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Infections and infestations Lung infection	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Infections and infestations Respiratory tract infection	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Infections and infestations Sepsis	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fall	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Hip fracture	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Investigations Blood creatinine increased	2.3% 3/132 • Number of events 4 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Investigations Electrocardiogram abnormal	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Investigations Liver function test abnormal	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Investigations Neutrophil count decreased	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Investigations Renal function test abnormal	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Investigations White blood cell count decreased	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	2.3% 3/132 • Number of events 3 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Nervous system disorders Epilepsy	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.5% 2/132 • Number of events 2 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.5% 2/132 • Number of events 2 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Vascular disorders Arterial thrombosis	0.76% 1/132 • Number of events 1 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Abemaciclib n=132 participants at risk 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Blood and lymphatic system disorders Anaemia	26.5% 35/132 • Number of events 96 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	18.2% 24/132 • Number of events 88 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	8.3% 11/132 • Number of events 21 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Eye disorders Lacrimation increased	8.3% 11/132 • Number of events 12 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	25.8% 34/132 • Number of events 54 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain upper	12.1% 16/132 • Number of events 19 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	20.5% 27/132 • Number of events 33 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	90.9% 120/132 • Number of events 370 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Dry mouth	13.6% 18/132 • Number of events 18 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	10.6% 14/132 • Number of events 16 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Flatulence	6.8% 9/132 • Number of events 11 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.3% 7/132 • Number of events 13 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	67.4% 89/132 • Number of events 141 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Stomatitis	9.1% 12/132 • Number of events 17 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	34.8% 46/132 • Number of events 91 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
General disorders Asthenia	23.5% 31/132 • Number of events 85 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
General disorders Chills	6.1% 8/132 • Number of events 8 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
General disorders Fatigue	47.7% 63/132 • Number of events 129 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
General disorders Oedema peripheral	10.6% 14/132 • Number of events 16 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
General disorders Pain	9.8% 13/132 • Number of events 19 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
General disorders Pyrexia	10.6% 14/132 • Number of events 17 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	6.8% 9/132 • Number of events 13 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	6.8% 9/132 • Number of events 9 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Investigations Alanine aminotransferase increased	8.3% 11/132 • Number of events 15 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Investigations Aspartate aminotransferase increased	9.1% 12/132 • Number of events 16 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Investigations Blood creatinine increased	11.4% 15/132 • Number of events 41 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Investigations Neutrophil count decreased	23.5% 31/132 • Number of events 105 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Investigations Platelet count decreased	13.6% 18/132 • Number of events 42 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Investigations Weight decreased	13.6% 18/132 • Number of events 22 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Investigations White blood cell count decreased	18.2% 24/132 • Number of events 69 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	45.5% 60/132 • Number of events 76 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	8.3% 11/132 • Number of events 15 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	6.8% 9/132 • Number of events 17 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	18.9% 25/132 • Number of events 32 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	12.1% 16/132 • Number of events 18 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	6.1% 8/132 • Number of events 9 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.1% 8/132 • Number of events 9 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	5.3% 7/132 • Number of events 8 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Nervous system disorders Dizziness	12.1% 16/132 • Number of events 18 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Nervous system disorders Dysgeusia	13.6% 18/132 • Number of events 19 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Nervous system disorders Headache	19.7% 26/132 • Number of events 40 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Psychiatric disorders Anxiety	6.1% 8/132 • Number of events 8 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	21.2% 28/132 • Number of events 42 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.9% 17/132 • Number of events 23 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	15.2% 20/132 • Number of events 21 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	8.3% 11/132 • Number of events 13 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	8.3% 11/132 • Number of events 13 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	5.3% 7/132 • Number of events 9 • Up To 45.57 Months All enrolled participants who received at least one dose of study drug.

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