Trial Outcomes & Findings for A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer (NCT NCT02152631)

Last Updated: 2026-02-06

Results Overview

OS defined as from randomization 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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

453 participants

Primary outcome timeframe

From Randomization Date to Date of Death from Any Cause (Up to 32 Months)

Results posted on

2026-02-06

Participant Flow

Completers are defined as those participants who had progressive disease, death due to any cause or alive and on study at the end of study, but off treatment.

Participant milestones

Participant milestones
Measure	Abemaciclib 200 milligrams (mg) abemaciclib administered, orally, every 12 hours plus best supportive care (BSC) on Days 1 to 28 (28 day cycles).	Erlotinib 150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Overall Study STARTED	270	183
Overall Study Received at Least One Dose of Study Drug	265	175
Overall Study Off Treatment	246	172
Overall Study Death Due to Any Cause	30	20
Overall Study Progressive Disease	174	137
Overall Study COMPLETED	204	157
Overall Study NOT COMPLETED	66	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Abemaciclib 200 milligrams (mg) abemaciclib administered, orally, every 12 hours plus best supportive care (BSC) on Days 1 to 28 (28 day cycles).	Erlotinib 150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Overall Study Adverse Event	32	4
Overall Study Withdrawal by Subject	13	16
Overall Study Noncompliance with study drug	1	0
Overall Study Physician Decision	1	2
Overall Study Lost to Follow-up	0	1
Overall Study On Treatment	19	3

Baseline Characteristics

A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abemaciclib n=270 Participants 200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).	Erlotinib n=183 Participants 150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).	Total n=453 Participants Total of all reporting groups
Age, Continuous	62.3 years STANDARD_DEVIATION 8.9 • n=192 Participants	62.9 years STANDARD_DEVIATION 8.4 • n=170 Participants	62.5 years STANDARD_DEVIATION 8.7 • n=185 Participants
Sex: Female, Male Female	107 Participants n=192 Participants	74 Participants n=170 Participants	181 Participants n=185 Participants
Sex: Female, Male Male	163 Participants n=192 Participants	109 Participants n=170 Participants	272 Participants n=185 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=192 Participants	12 Participants n=170 Participants	25 Participants n=185 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	197 Participants n=192 Participants	132 Participants n=170 Participants	329 Participants n=185 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	60 Participants n=192 Participants	39 Participants n=170 Participants	99 Participants n=185 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=192 Participants	1 Participants n=170 Participants	1 Participants n=185 Participants
Race (NIH/OMB) Asian	56 Participants n=192 Participants	41 Participants n=170 Participants	97 Participants n=185 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=192 Participants	0 Participants n=170 Participants	0 Participants n=185 Participants
Race (NIH/OMB) Black or African American	1 Participants n=192 Participants	2 Participants n=170 Participants	3 Participants n=185 Participants
Race (NIH/OMB) White	165 Participants n=192 Participants	106 Participants n=170 Participants	271 Participants n=185 Participants
Race (NIH/OMB) More than one race	3 Participants n=192 Participants	1 Participants n=170 Participants	4 Participants n=185 Participants
Race (NIH/OMB) Unknown or Not Reported	45 Participants n=192 Participants	32 Participants n=170 Participants	77 Participants n=185 Participants
Region of Enrollment Argentina	1 Participants n=192 Participants	2 Participants n=170 Participants	3 Participants n=185 Participants
Region of Enrollment Romania	7 Participants n=192 Participants	7 Participants n=170 Participants	14 Participants n=185 Participants
Region of Enrollment United States	44 Participants n=192 Participants	30 Participants n=170 Participants	74 Participants n=185 Participants
Region of Enrollment Japan	22 Participants n=192 Participants	17 Participants n=170 Participants	39 Participants n=185 Participants
Region of Enrollment Ukraine	6 Participants n=192 Participants	5 Participants n=170 Participants	11 Participants n=185 Participants
Region of Enrollment Russia	8 Participants n=192 Participants	4 Participants n=170 Participants	12 Participants n=185 Participants
Region of Enrollment Spain	26 Participants n=192 Participants	13 Participants n=170 Participants	39 Participants n=185 Participants
Region of Enrollment Greece	1 Participants n=192 Participants	6 Participants n=170 Participants	7 Participants n=185 Participants
Region of Enrollment Canada	4 Participants n=192 Participants	4 Participants n=170 Participants	8 Participants n=185 Participants
Region of Enrollment Austria	0 Participants n=192 Participants	2 Participants n=170 Participants	2 Participants n=185 Participants
Region of Enrollment South Korea	13 Participants n=192 Participants	13 Participants n=170 Participants	26 Participants n=185 Participants
Region of Enrollment Turkey	21 Participants n=192 Participants	8 Participants n=170 Participants	29 Participants n=185 Participants
Region of Enrollment China	7 Participants n=192 Participants	4 Participants n=170 Participants	11 Participants n=185 Participants
Region of Enrollment Taiwan	12 Participants n=192 Participants	7 Participants n=170 Participants	19 Participants n=185 Participants
Region of Enrollment Brazil	7 Participants n=192 Participants	5 Participants n=170 Participants	12 Participants n=185 Participants
Region of Enrollment Poland	6 Participants n=192 Participants	2 Participants n=170 Participants	8 Participants n=185 Participants
Region of Enrollment Italy	5 Participants n=192 Participants	12 Participants n=170 Participants	17 Participants n=185 Participants
Region of Enrollment Israel	5 Participants n=192 Participants	1 Participants n=170 Participants	6 Participants n=185 Participants
Region of Enrollment France	35 Participants n=192 Participants	32 Participants n=170 Participants	67 Participants n=185 Participants
Region of Enrollment Germany	30 Participants n=192 Participants	14 Participants n=170 Participants	44 Participants n=185 Participants

PRIMARY outcome

Timeframe: From Randomization Date to Date of Death from Any Cause (Up to 32 Months)

Population: All randomized participants. 81 participants were censored in the Abemaciclib arm and 56 participants were censored in the Erlotinib arm.

Outcome measures

Outcome measures
Measure	Abemaciclib n=270 Participants 200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).	Erlotinib n=183 Participants 150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Overall Survival (OS)	7.4 months Interval 6.5 to 8.8	7.8 months Interval 6.4 to 9.5

SECONDARY outcome

Timeframe: From Randomization Date to Objective Progression (Up to 32 Months)

Population: All randomized participants.

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.

Outcome measures

Outcome measures
Measure	Abemaciclib n=270 Participants 200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).	Erlotinib n=183 Participants 150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])	8.9 percentage of participants Interval 5.5 to 12.3	2.7 percentage of participants Interval 0.4 to 5.1

SECONDARY outcome

Timeframe: From Randomization Date until Disease Progression or Death from Any Cause (Up to 32 Months)

Population: All randomized participants. 36 participants were censored in the abemaciclib arm and 24 were censored in the erlotinib arm.

PFS defined as the from randomization date 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=270 Participants 200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).	Erlotinib n=183 Participants 150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Progression Free Survival (PFS)	3.6 months Interval 2.8 to 3.8	1.9 months Interval 1.9 to 2.0

SECONDARY outcome

Timeframe: From Randomization Date through End of Study (Up to 32 Months)

Population: All randomized participants for cycles which at least 25% of participants in each arm have a score. MDASI-LC population included all randomized participants who completed at least 1 baseline assessment followed by at least 1 MDASI-LC result.

The MDASI-LC included 22 items + 3 additional trial-specific items, resulting in 6 collected and reported single-construct scores including core symptoms (13-item), interference (6-item), lung cancer (3-item), and trial-specific single outcomes for headache, diarrhea, and rash. A 2-construct composite core + lung cancer symptom (16-item) score was calculated. Data for all 7 scores were collected by an 11-point numeric rating scale anchored at 0 (not present or does not interfere) and 10 (as bad as you can imagine or interfered completely). The measurement range was 10 (maximum score-minimum score). Mixed Model Repeated Measure (MMRM) regression with covariates for treatment, visit, treatment\*visit, and baseline score predicted between-group Least Squares (LS) mean differences from baseline. Group-level negative change from baseline indicated group improvement.

Outcome measures

Outcome measures
Measure	Abemaciclib n=270 Participants 200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).	Erlotinib n=183 Participants 150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score Headache	0.20 units on a scale Standard Error 0.11	0.27 units on a scale Standard Error 0.15
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score Diarrhea	1.91 units on a scale Standard Error 0.17	1.32 units on a scale Standard Error 0.23
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score Rash	0.65 units on a scale Standard Error 0.17	3.05 units on a scale Standard Error 0.22
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score Mean Core Symptom Severity	0.49 units on a scale Standard Error 0.10	0.73 units on a scale Standard Error 0.13
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score Mean Interference	0.70 units on a scale Standard Error 0.14	0.85 units on a scale Standard Error 0.18
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score Mean Lung Cancer Symptom Severity	0.16 units on a scale Standard Error 0.09	0.23 units on a scale Standard Error 0.12
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score Mean Core Plus Lung Cancer Symptom Severity	0.44 units on a scale Standard Error 0.09	0.65 units on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 through Cycle 3 (28 Day Cycles)

Population: All randomized participants who received Abemaciclib and had evaluable PK data.

PK is determined by the area under the plasma concentration versus time curve during 1 dosing interval at steady state

Outcome measures

Outcome measures
Measure	Abemaciclib n=265 Participants 200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).	Erlotinib 150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval at Steady State	3350 Hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 52	—

SECONDARY outcome

Timeframe: From Randomization Date through End of Study (Up to 32 Months)

Population: All randomized participants who received at least one dose of study drug and with a baseline and at least 1 post-baseline result.

There are 5 response levels on a good-to-bad continuum of 1-5 corresponding to none, slight, moderate, severe, and extreme/unable to. The EuroQol-developed crosswalk method was used to convert the EQ-5D-5L,using United Kingdom (UK) weights, health dimensions(mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) into a single index value; the dimensions are not separately scored. The index is marked missing when ≥1 dimensions are missing. The index scores for the response patterns were anchored on full health to dead with negative values assigned to response patterns/health states considered worse than death. The best pattern is assigned the index value of 1.0; the worst pattern is assigned an index value of -0.594. Between-group differences in regression-predicted change from baseline score were estimated for the index. LS Mean value was controlled for Treatment, visit, Treatment\*Visit and baseline.

Outcome measures

Outcome measures
Measure	Abemaciclib n=270 Participants 200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).	Erlotinib n=183 Participants 150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Score	-0.08 units on a scale Standard Error 0.01	-0.08 units on a scale Standard Error 0.02

SECONDARY outcome

Timeframe: From Randomization Date through End of Study (Up to 32 Months)

Population: All randomized participants.

Resource utilization is the percentage of participants who was hospitalized.

Outcome measures

Outcome measures
Measure	Abemaciclib n=265 Participants 200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).	Erlotinib n=175 Participants 150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Resource Utilization: Percentage of Participants Who Are Hospitalized	40.4 percentage of participants	22.9 percentage of participants

Adverse Events

Abemaciclib

Serious events: 112 serious events

Other events: 247 other events

Deaths: 186 deaths

Erlotinib

Serious events: 43 serious events

Other events: 161 other events

Deaths: 123 deaths

Serious adverse events

Other adverse events

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

Measure	Abemaciclib n=265 participants at risk 200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).	Erlotinib n=175 participants at risk 150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Blood and lymphatic system disorders Thrombocytopenia	6.4% 17/265 • Number of events 25 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	0.57% 1/175 • Number of events 3 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	11.3% 30/265 • Number of events 34 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	4.6% 8/175 • Number of events 8 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	10.9% 29/265 • Number of events 32 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	8.6% 15/175 • Number of events 17 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	63.8% 169/265 • Number of events 331 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	39.4% 69/175 • Number of events 100 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	35.5% 94/265 • Number of events 127 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	17.1% 30/175 • Number of events 33 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Stomatitis	5.3% 14/265 • Number of events 14 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	5.7% 10/175 • Number of events 10 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	23.0% 61/265 • Number of events 89 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	8.6% 15/175 • Number of events 15 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
General disorders Asthenia	16.6% 44/265 • Number of events 82 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	7.4% 13/175 • Number of events 16 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
General disorders Fatigue	27.5% 73/265 • Number of events 132 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	16.6% 29/175 • Number of events 38 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
General disorders Non-cardiac chest pain	5.7% 15/265 • Number of events 17 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	4.0% 7/175 • Number of events 7 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
General disorders Pyrexia	12.5% 33/265 • Number of events 40 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	6.3% 11/175 • Number of events 11 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Investigations Aspartate aminotransferase increased	5.7% 15/265 • Number of events 26 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	4.0% 7/175 • Number of events 8 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Investigations Blood creatinine increased	17.0% 45/265 • Number of events 81 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	1.1% 2/175 • Number of events 2 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Investigations Neutrophil count decreased	15.1% 40/265 • Number of events 130 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	1.1% 2/175 • Number of events 4 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Investigations Platelet count decreased	15.8% 42/265 • Number of events 103 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	2.9% 5/175 • Number of events 7 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Investigations Weight decreased	15.8% 42/265 • Number of events 54 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	9.1% 16/175 • Number of events 22 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Investigations White blood cell count decreased	10.6% 28/265 • Number of events 83 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	2.3% 4/175 • Number of events 6 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	35.8% 95/265 • Number of events 133 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	24.0% 42/175 • Number of events 52 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	5.7% 15/265 • Number of events 18 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	0.57% 1/175 • Number of events 1 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	6.8% 18/265 • Number of events 24 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	4.6% 8/175 • Number of events 15 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	8.3% 22/265 • Number of events 31 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	5.1% 9/175 • Number of events 10 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Psychiatric disorders Insomnia	5.7% 15/265 • Number of events 16 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	4.0% 7/175 • Number of events 7 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	6.4% 17/265 • Number of events 37 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	3.4% 6/175 • Number of events 11 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	5.7% 15/265 • Number of events 15 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	6.3% 11/175 • Number of events 15 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Nervous system disorders Dizziness	6.8% 18/265 • Number of events 19 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	2.9% 5/175 • Number of events 6 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Nervous system disorders Headache	9.1% 24/265 • Number of events 29 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	6.3% 11/175 • Number of events 12 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Blood and lymphatic system disorders Anaemia	32.8% 87/265 • Number of events 163 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	13.1% 23/175 • Number of events 30 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	7.2% 19/265 • Number of events 44 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	0.57% 1/175 • Number of events 1 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 38/265 • Number of events 45 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	12.0% 21/175 • Number of events 22 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 53/265 • Number of events 74 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	12.6% 22/175 • Number of events 26 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	6.0% 16/265 • Number of events 17 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	2.3% 4/175 • Number of events 4 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.38% 1/265 • Number of events 4 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	26.3% 46/175 • Number of events 68 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	5.3% 14/265 • Number of events 14 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	14.9% 26/175 • Number of events 35 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	6.4% 17/265 • Number of events 22 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	10.3% 18/175 • Number of events 27 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	4.2% 11/265 • Number of events 14 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.	24.0% 42/175 • Number of events 68 • From Baseline to End of Study (Up to 47 Months) All randomized participants who received at least one dose of study drug.