Trial Outcomes & Findings for A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation (NCT NCT04165031)

Last Updated: 2021-11-24

Results Overview

DLT is defined as an event that is clinically significant and not clearly related to disease progression or intercurrent illness that occurred within the DLT observation period of the Cycle 1 timeframe.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Cycle 1 (21 Day Cycle)

Results posted on

2021-11-24

Participant Flow

A participant was identified as having completed the study if the participant was observed until event of progressive disease (PD) or death, or the participant had discontinued study treatment and is in follow up at the time of the final analysis. The study was terminated due to an unexpected toxicity finding.

Participant milestones

Participant milestones
Measure	LY3499446 Phase 1 Cohort A1 (High Dose) Participants received high dose LY3499446 as oral monotherapy twice daily (BID) in 21-day cycles.	LY3499446 Phase 1 Cohort AO (Mid Dose) Participant received mid dose LY3499446 as oral monotherapy once every other day (QOD) in 21-day cycles.	LY3499446 Phase 1 Cohort A-2 (Low Dose) Participants received low dose LY 3499446 as oral monotherapy once daily (QD) in 21-day cycles.
Overall Study STARTED	2	1	2
Overall Study Received at Least One Dose of Study Drug	2	1	2
Overall Study COMPLETED	1	0	1
Overall Study NOT COMPLETED	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	LY3499446 Phase 1 Cohort A1 (High Dose) Participants received high dose LY3499446 as oral monotherapy twice daily (BID) in 21-day cycles.	LY3499446 Phase 1 Cohort AO (Mid Dose) Participant received mid dose LY3499446 as oral monotherapy once every other day (QOD) in 21-day cycles.	LY3499446 Phase 1 Cohort A-2 (Low Dose) Participants received low dose LY 3499446 as oral monotherapy once daily (QD) in 21-day cycles.	LY3499446 + Combination Drug Phase 1 LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV). The trial was terminated prior to initiation of this portion.	LY3499446 Monotherapy + Combination Drug Phase 2 LY3499446 monotherapy orally. LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV). The trial was terminated prior to initiation of this portion.	Docetaxel Phase 2 Docetaxel IV infusion. The trial was terminated prior to initiation of this portion.
Overall Study Adverse Event	1	1	0	0	0	0
Overall Study Withdrawal by Subject	0	0	1	0	0	0

Baseline Characteristics

A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LY3499446 Phase 1 Cohort A1 (High Dose) n=2 Participants Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.	LY3499446 Phase 1 Cohort AO (Mid Dose) n=1 Participants Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.	LY3499446 Phase 1 Cohort A-2 (Low Dose) n=2 Participants Participants received low dose LY 3499446 as oral monotherapy once QD in 21-day cycles.	LY3499446 + Combination Drug Phase 1 LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV). The trial was terminated prior to initiation of this portion.	LY3499446 Monotherapy + Combination Drug Phase 2 LY3499446 monotherapy orally. LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV). The trial was terminated prior to initiation of this portion.	Docetaxel Phase 2 Docetaxel IV infusion. The trial was terminated prior to initiation of this portion.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	5 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	5 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Region of Enrollment United States	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Region of Enrollment Australia	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants

PRIMARY outcome

Timeframe: Cycle 1 (21 Day Cycle)

Population: All participants who received at least one dose of study drug and had a dose limiting toxicity.

Outcome measures

Outcome measures
Measure	LY3499446 Phase 1 Cohort A1 (High Dose) n=2 Participants Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.	LY3499446 Phase 1 Cohort AO (Mid Dose) n=1 Participants Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.	LY3499446 Phase 1 Cohort A-2 (Low Dose) n=2 Participants Participants received low dose LY3499446 as oral monotherapy once QD in 21-day cycles.
Phase 1: Number or Participants With Dose Limiting Toxicities (DLTs)	2 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline through Measured Progressive Disease

Population: Zero participants were analyzed due to early termination of study.

ORR is defined as percentage of participants who achieved a CR or PR out of all the participants treated. Tumor responses were measured and record using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST) v1.1 guidelines. CR is defined as the disappearance of all targeted and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (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 data not reported

PRIMARY outcome

Timeframe: Baseline to Objective Progression or Death Due to Any Cause

Population: Zero participants were analyzed due to early termination of study.

PFS was defined as the time from study enrollment (for non-randomized cohorts)/ the time from randomization (for randomized cohorts) to the first observation of progressive disease (PD) or death without documented disease progression per RECIST V1.1 criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 8, 24 hours post-dose

Population: All participants who have received at least one dose of study drug and had evaluable PK.

Average concentration after the first dose of LY3499446.

Outcome measures

Outcome measures
Measure	LY3499446 Phase 1 Cohort A1 (High Dose) n=2 Participants Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.	LY3499446 Phase 1 Cohort AO (Mid Dose) n=1 Participants Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.	LY3499446 Phase 1 Cohort A-2 (Low Dose) n=2 Participants Participants received low dose LY3499446 as oral monotherapy once QD in 21-day cycles.
Phase 1: Pharmacokinetics (PK): Average Concentration of LY3499446	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA N=2: Geometric mean and Geometric Coefficient of Variation were not calculated, individual values reported:1056 ng/mL and 570 ng/mL.	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA N=1: Geometric mean and Geometric Coefficient of Variation were not calculated, individual values reported: 865 ng/mL.	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA N=2: Geometric mean and Geometric Coefficient of Variation were not calculated, individual values reported: 225 ng/mL and 116 ng/mL.

SECONDARY outcome

Timeframe: Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)

Population: Zero participants were analyzed due to early termination of study.

PK: Average Concentration at Steady State of LY3499446 in Combination with Abemaciclib

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)

Population: Zero participants were analyzed due to early termination of study.

PK: Average Concentration at Steady State of LY3499446 in Combination with Cetuximab

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)

Population: Zero participants were analyzed due to early termination of study.

PK: Average Concentration at Steady State of LY3499446 in Combination with Erlotinib

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through Measured Progressive Disease (Up to 11 Months)

Population: Zero participants were analyzed due to early termination of study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Objective Progression or Death Due to Any Cause (Up to 11 Months)

Population: Zero participants were analyzed due to early termination of study.

PFS was defined as the time from study enrollment (for non-randomized cohorts)/ the time from randomization (for randomized cohorts) to the first observation of progressive disease (PD) overall response or death without documented disease progression per RECIST V1.1 criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 11 Months)

Population: Zero participants were analyzed due to early termination of study.

DoR was defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST v1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through Measured Progressive Disease (Up to 11 Months)

Population: Zero participants were analyzed due to early termination of study.

DCR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed CR, confirmed PR, or SD out of all participants treatment. Best response is determined from a sequence of responses assessed. Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. CR is defined as the disappearance of all targeted and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (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 data not reported

Adverse Events

LY3499446 Phase 1 Cohort A1 (High Dose)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

LY3499446 Phase 1 Cohort AO (Mid Dose)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

LY3499446 Phase 1 Cohort A-2 (Low Dose)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	LY3499446 Phase 1 Cohort A1 (High Dose) n=2 participants at risk Participants received high dose LY3499446 as oral monotherapy twice daily (BID) in 21-day cycles.	LY3499446 Phase 1 Cohort AO (Mid Dose) n=1 participants at risk Participant received mid dose LY3499446 as oral monotherapy once every other day (QOD) in 21-day cycles.	LY3499446 Phase 1 Cohort A-2 (Low Dose) n=2 participants at risk Participants received low dose LY3499446 as monotherapy orally once QD in 21-day cycles.
General disorders Pyrexia	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.

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	LY3499446 Phase 1 Cohort A1 (High Dose) n=2 participants at risk Participants received high dose LY3499446 as oral monotherapy twice daily (BID) in 21-day cycles.	LY3499446 Phase 1 Cohort AO (Mid Dose) n=1 participants at risk Participant received mid dose LY3499446 as oral monotherapy once every other day (QOD) in 21-day cycles.	LY3499446 Phase 1 Cohort A-2 (Low Dose) n=2 participants at risk Participants received low dose LY3499446 as monotherapy orally once QD in 21-day cycles.
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	100.0% 1/1 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.
Blood and lymphatic system disorders Haemolysis	100.0% 2/2 • Number of events 2 • Baseline up to 11 months All participants who received at least one dose of study drug.	100.0% 1/1 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Cardiac disorders Cardiac arrest	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Cardiac disorders Palpitations	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 2 • Baseline up to 11 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	100.0% 2/2 • Number of events 4 • Baseline up to 11 months All participants who received at least one dose of study drug.
General disorders Fatigue	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	100.0% 2/2 • Number of events 3 • Baseline up to 11 months All participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Investigations Blood bilirubin increased	100.0% 2/2 • Number of events 3 • Baseline up to 11 months All participants who received at least one dose of study drug.	100.0% 1/1 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.
Investigations Haptoglobin decreased	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Nervous system disorders Amnesia	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.
Nervous system disorders Dizziness	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.
Nervous system disorders Dysgeusia	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Nervous system disorders Headache	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.
Nervous system disorders Paraesthesia	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	50.0% 1/2 • Number of events 2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/2 • Baseline up to 11 months All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline up to 11 months All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline up to 11 months All participants who received at least one dose of study drug.