Trial Outcomes & Findings for Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain (NCT NCT04778592)

Last Updated: 2023-11-07

Results Overview

Change from baseline in the weekly average of the daily pain score as derived from the subject's responses on the Pain Intensity Numerical Rating Scale (PI-NRS), a 10 point scale from 0 being the least (No Pain) to 10 being the most (Worst Possible Pain).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

149 participants

Primary outcome timeframe

Baseline to Week 4

Results posted on

2023-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	ETX-018810 Drug: ETX-018810 bid ETX-018810: Study Drug	Placebo Matching Placebo bid Placebo: Placebo
Overall Study STARTED	75	74
Overall Study COMPLETED	73	70
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	ETX-018810 Drug: ETX-018810 bid ETX-018810: Study Drug	Placebo Matching Placebo bid Placebo: Placebo
Overall Study Adverse Event	1	2
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ETX-018810 n=74 Participants Drug: ETX-018810 bid ETX-018810: Study Drug	Placebo n=74 Participants Matching Placebo bid Placebo: Placebo	Total n=148 Participants Total of all reporting groups
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 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
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=5 Participants	61 Participants n=7 Participants	118 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants	13 Participants n=7 Participants	30 Participants n=5 Participants
Age, Continuous	55.8 years STANDARD_DEVIATION 12.29 • n=5 Participants	53.8 years STANDARD_DEVIATION 10.67 • n=7 Participants	54.8 years STANDARD_DEVIATION 11.51 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	36 Participants n=7 Participants	82 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	38 Participants n=7 Participants	66 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) White	56 Participants n=5 Participants	55 Participants n=7 Participants	111 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	74 participants n=5 Participants	74 participants n=7 Participants	148 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 4

Population: The modified ITT population included all randomized subjects who received at least one dose of study treatment and had at least four post-baseline PI-NRS measurements; 73 subjects in both the ETX-018810 and Placebo groups. All subjects in this population were included in the statistical analysis comparing the groups. However, the descriptive statistics for Week 4 only include those subjects who had measurements at Baseline and Week 4 (72 and 70 subjects, respectively).

Outcome measures

Outcome measures
Measure	ETX-018810 n=72 Participants Drug: ETX-018810 bid ETX-018810: Study Drug	Placebo n=70 Participants Matching Placebo bid Placebo: Placebo
Change From Baseline to Week 4 in the Weekly Average of the Daily Pain Score as Derived From the Subject's Responses on the Pain Intensity Numerical Rating Scale (PI-NRS)	-1.49 units on a scale Standard Deviation 1.735	-1.65 units on a scale Standard Deviation 1.760

SECONDARY outcome

Timeframe: Baseline to Weeks 1, 2, 3 and 4

Change in the weekly average of the daily pain score as derived from the subject's responses on the Pain Intensity Numerical Rating Scale (PI-NRS), a 10 point scale from 0 being the least (No Pain) to 10 being the most (Worst Possible Pain).

Outcome measures

Outcome measures
Measure	ETX-018810 n=73 Participants Drug: ETX-018810 bid ETX-018810: Study Drug	Placebo n=73 Participants Matching Placebo bid Placebo: Placebo
Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score Week 1	4 Participants	3 Participants
Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score Week 2	9 Participants	8 Participants
Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score Week 3	12 Participants	17 Participants
Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score Week 4	14 Participants	17 Participants

SECONDARY outcome

Timeframe: Baseline to Weeks 1, 2, 3 and 4

Outcome measures

Outcome measures
Measure	ETX-018810 n=73 Participants Drug: ETX-018810 bid ETX-018810: Study Drug	Placebo n=73 Participants Matching Placebo bid Placebo: Placebo
Number of Subjects With a ≥30% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score Week 1	9 Participants	17 Participants
Number of Subjects With a ≥30% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score Week 2	18 Participants	19 Participants
Number of Subjects With a ≥30% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score Week 3	22 Participants	28 Participants
Number of Subjects With a ≥30% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score Week 4	28 Participants	29 Participants

SECONDARY outcome

Timeframe: Baseline to Weeks 1, 2, and 3

Outcome measures

Outcome measures
Measure	ETX-018810 n=73 Participants Drug: ETX-018810 bid ETX-018810: Study Drug	Placebo n=73 Participants Matching Placebo bid Placebo: Placebo
Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3 Week 1	-0.66 score on a scale Standard Deviation 1.079	-0.85 score on a scale Standard Deviation 0.994
Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3 Week 2	-1.04 score on a scale Standard Deviation 1.479	-1.15 score on a scale Standard Deviation 1.429
Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3 Week 3	-1.28 score on a scale Standard Deviation 1.575	-1.49 score on a scale Standard Deviation 1.606

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: The ITT population included all randomized subjects who received at least one dose of study treatment; 74 subjects in both the ETX-018810 and Placebo groups. Not all subjects had a BPI assessment at Week 4.

The Brief Pain Inventory (BPI) includes a 'worst pain' severity scale. Subjects rate their worst pain in the last 24 hours on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).

Outcome measures

Outcome measures
Measure	ETX-018810 n=73 Participants Drug: ETX-018810 bid ETX-018810: Study Drug	Placebo n=72 Participants Matching Placebo bid Placebo: Placebo
Change From Baseline to Week 4 for Worst Pain	-1.73 score on a scale Standard Deviation 2.206	-1.74 score on a scale Standard Deviation 1.861

SECONDARY outcome

Timeframe: Week 4

The Patient Global Impression - Change (PGI-C) is the patient-reported counterpoint to the CGI-C (Guy, 1976). The qualitative assessment of meaningful change is determined by the patient in response to the question, "Compared to your condition at the beginning of treatment, how much has your condition changed?" Scores are as follows: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse.

Outcome measures

Outcome measures
Measure	ETX-018810 n=74 Participants Drug: ETX-018810 bid ETX-018810: Study Drug	Placebo n=73 Participants Matching Placebo bid Placebo: Placebo
Number of Subjects With a PGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4	23 Participants	25 Participants

SECONDARY outcome

Timeframe: Week 4

The Clinical Global Impression - Change (CGI-C) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to the baseline state at the beginning of the intervention. The rater selects one response based on the following question, "Compared to your patient's condition at the beginning of treatment, how much has your patient changed?" Scores are as follows: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse.

Outcome measures

Outcome measures
Measure	ETX-018810 n=74 Participants Drug: ETX-018810 bid ETX-018810: Study Drug	Placebo n=73 Participants Matching Placebo bid Placebo: Placebo
Number of Subjects With a CGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4	21 Participants	24 Participants

SECONDARY outcome

Timeframe: Baseline to Weeks 1, 2, 3 and 4

The Daily Sleep Interference Scale (DSIS) is an 11-point response scale that quantifies sleep interference due to pain. It is a single-item measure that is completed once daily, upon awakening, to accurately capture variability in sleep interference due to pain on a daily basis, thus minimizing recall bias. Patients are asked to select the number that best described how much their pain has interfered with their sleep during the last 24 hours on a scale from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). The subjects were to record the value that most closely corresponded to their sleep interference over the last 24 hours in the eDiary once daily, in the morning (when the first dose of investigational medication is taken), during the baseline and 4-week treatment periods.

Outcome measures

Outcome measures
Measure	ETX-018810 n=73 Participants Drug: ETX-018810 bid ETX-018810: Study Drug	Placebo n=73 Participants Matching Placebo bid Placebo: Placebo
Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4 Week 1	-0.87 score on a scale Standard Deviation 1.279	-0.81 score on a scale Standard Deviation 1.114
Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4 Week 2	-1.14 score on a scale Standard Deviation 1.576	-1.18 score on a scale Standard Deviation 1.366
Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4 Week 3	-1.41 score on a scale Standard Deviation 1.697	-1.51 score on a scale Standard Deviation 1.520
Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4 Week 4	-1.59 score on a scale Standard Deviation 1.676	-1.53 score on a scale Standard Deviation 1.706

SECONDARY outcome

Timeframe: Baseline to Week 4

The Brief Pain Inventory (BPI) interference score measures how much pain has interfered with seven daily activities scored on a scale from 0 (does not interfere) to 10 (completely interferes). It is scored as the mean of the seven interference items.

Outcome measures

Outcome measures
Measure	ETX-018810 n=73 Participants Drug: ETX-018810 bid ETX-018810: Study Drug	Placebo n=72 Participants Matching Placebo bid Placebo: Placebo
Change in BPI - Interference Scale From Baseline to Week 4	-1.68 score on a scale Standard Deviation 1.967	-1.94 score on a scale Standard Deviation 1.954

SECONDARY outcome

Timeframe: Baseline to Week 4

The Brief Pain Inventory (BPI) pain score is a composite of 4 items assessing pain severity (worst, least, average and right now). Subjects rate their pain in the last 24 hours on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). It is scored as the mean of the four pain items.

Outcome measures

Outcome measures
Measure	ETX-018810 n=73 Participants Drug: ETX-018810 bid ETX-018810: Study Drug	Placebo n=72 Participants Matching Placebo bid Placebo: Placebo
Change in the BPI - Pain Scale From Baseline to Week 4	-1.70 score on a scale Standard Deviation 1.974	-1.57 score on a scale Standard Deviation 1.588

SECONDARY outcome

Timeframe: Baseline to Week 4

The modified Roland-Morris Disability Questionnaire (RMDQ) is a self-administered, 24-question physical disability measurement assessment that evaluates the effect of back pain on functioning. Each question requires a "yes" or "no" answer; 1 point is scored for each positive response. The total scores are determined on a scale of 0 ("no disability") to 24 ("severe disability").

Outcome measures

Outcome measures
Measure	ETX-018810 n=73 Participants Drug: ETX-018810 bid ETX-018810: Study Drug	Placebo n=71 Participants Matching Placebo bid Placebo: Placebo
Change in the RMDQ From Baseline to Week 4	-2.10 score on a scale Standard Deviation 3.637	-2.31 score on a scale Standard Deviation 4.367

SECONDARY outcome

Timeframe: Treatment period: 4 weeks

The daily amount of acetaminophen (rescue medication) used (mg per day).

Outcome measures

Outcome measures
Measure	ETX-018810 n=72 Participants Drug: ETX-018810 bid ETX-018810: Study Drug	Placebo n=71 Participants Matching Placebo bid Placebo: Placebo
Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4	0 mg per day Interval -99.4 to 0.0	0 mg per day Interval -177.3 to 9.3

Adverse Events

ETX-018810

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ETX-018810 n=74 participants at risk Drug: ETX-018810 bid ETX-018810: Study Drug	Placebo n=74 participants at risk Matching Placebo bid Placebo: Placebo
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)

Other adverse events

Additional Information

Clinical Operations

Eliem Therapeutics

Phone: +1-888-506-2573

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the PI will provide the sponsor with a copy of any proposed communication at least 90 days in advance of the proposed submission or presentation date. Within this 90 day period, the sponsor will review the communication to determine whether it contains any sponsor Confidential Information, or whether the sponsor desires to file patent applications on subject matter contained therein, and to ensure the accuracy of the information.
Publication restrictions are in place

Restriction type: OTHER

Measure	ETX-018810 n=74 participants at risk Drug: ETX-018810 bid ETX-018810: Study Drug	Placebo n=74 participants at risk Matching Placebo bid Placebo: Placebo
Gastrointestinal disorders Nausea	2.7% 2/74 • Number of events 2 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Gastrointestinal disorders Abdominal discomfort	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Gastrointestinal disorders Abdominal pain	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Gastrointestinal disorders Diarrhoea	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Gastrointestinal disorders Dyspepsia	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Investigations Blood creatine phosphokinase increased	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Investigations Haematocrit decreased	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Investigations SARS-CoV-2 test positive	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Investigations Weight increased	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
General disorders Asthenia	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
General disorders Fatigue	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
General disorders Chest discomfort	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
General disorders Peripheral swelling	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Infections and infestations Nasopharyngitis	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Infections and infestations Otitis media	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Skin and subcutaneous tissue disorders Hyperhidrosis	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Skin and subcutaneous tissue disorders Rash	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Skin and subcutaneous tissue disorders Blister	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Metabolism and nutrition disorders Hyperglycaemia	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Nervous system disorders Dizziness	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Nervous system disorders Headache	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	4.1% 3/74 • Number of events 3 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Nervous system disorders Lethargy	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Nervous system disorders Restless legs syndrome	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Nervous system disorders Sciatica	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Nervous system disorders Somnolence	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Hepatobiliary disorders Hepatomegaly	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Psychiatric disorders Abnormal dreams	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/74 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)	1.4% 1/74 • Number of events 1 • 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)