Trial Outcomes & Findings for MEA112997 Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects (NCT NCT01691859)

NCT ID: NCT01691859

Last Updated: 2023-06-28

Results Overview

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product (MP), whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. As Treated (AT) Population consisted of participants who received at least one dose of open label mepolizumab. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 347 participants
• Primary outcome timeframe: Baseline (Week 0) to Week 240
• Results posted on: 2023-06-28

Participant Flow

This was a multi-center, open-label, long term safety study of mepolizumab in 347 asthmatic participants who participated in the MEA112997 trial and were found eligible for this study after screening and run in phase. The study was conducted at 65 centers in 13 countries from 28 Sep 2012 to 31 May 2017.

A total of 362 participants were screened; 4 participants were screen failures (did not meet the inclusion/exclusion criteria); 11 participants were withdrawn during the run-in period (4 did not meet the continuation criteria, 4 withdrawal by participant and 3 following physician decision).

Participant milestones

Measure	Mepolizumab 100 mg Participants received 100 milligram (mg) of mepolizumab injected subcutaneously (SC) once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Overall Study STARTED	347
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	347

Reasons for withdrawal

Measure	Mepolizumab 100 mg Participants received 100 milligram (mg) of mepolizumab injected subcutaneously (SC) once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Overall Study Adverse Event	19
Overall Study Lack of Efficacy	11
Overall Study Protocol Violation	4
Overall Study Product commercially available	221
Overall Study Study closed/terminated	50
Overall Study Lost to Follow-up	5
Overall Study Physician Decision	6
Overall Study Withdrawal by Subject	31

Baseline Characteristics

MEA112997 Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects

Baseline characteristics by cohort

Measure	Mepolizumab 100 mg n=347 Participants Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Age, Continuous	52.2 Years STANDARD_DEVIATION 10.73 • n=5 Participants
Sex: Female, Male Female	224 Participants n=5 Participants
Sex: Female, Male Male	123 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	8 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	14 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	7 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	311 Participants n=5 Participants
Race/Ethnicity, Customized Asian & Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) to Week 240

Population: AT Population.

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product (MP), whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. As Treated (AT) Population consisted of participants who received at least one dose of open label mepolizumab. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days.

Outcome measures

Measure	Mepolizumab 100 mg n=347 Participants Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Number of Participants Who Experienced On-treatment Adverse Events (AE) and On-treatment Serious Adverse Events (SAE) AE	326 Participants
Number of Participants Who Experienced On-treatment Adverse Events (AE) and On-treatment Serious Adverse Events (SAE) SAE	79 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 240

Population: AT Population.

Systemic and local site reactions following mepolizumab dosing as identified by the investigator and the number of participants who experienced systemic and/or local site reactions are presented. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days.

Outcome measures

Measure	Mepolizumab 100 mg n=347 Participants Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Number of Participants Who Experienced On-treatment Systemic (i.e., Allergic/Immunoglobulin E [IgE]-Mediated and Non-allergic) and On-treatment Local Site Reactions Systemic reactions	9 Participants
Number of Participants Who Experienced On-treatment Systemic (i.e., Allergic/Immunoglobulin E [IgE]-Mediated and Non-allergic) and On-treatment Local Site Reactions Local site reactions	42 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 240

Population: AT Population.

Twelve-lead ECGs were performed at Screening and every 24 weeks during the treatment period. ECG measurements were made after the participant had rested in the supine position for 5 minutes. Collection shortly after a meal or during sleep was avoided as QT prolongation can occur at these times. Baseline was the last available ECG prior to mepolizumab dosing. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.

Outcome measures

Measure	Mepolizumab 100 mg n=347 Participants Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B]) Week 24, n=330	4.2 Milliseconds Standard Deviation 18.57
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B]) Week 48, n=319	3.2 Milliseconds Standard Deviation 17.19
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B]) Week 72, n=307	-0.5 Milliseconds Standard Deviation 16.76
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B]) Week 96, n=293	1.3 Milliseconds Standard Deviation 17.92
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B]) Week 124, n=292	1.5 Milliseconds Standard Deviation 19.69
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B]) Week 148, n=275	1.6 Milliseconds Standard Deviation 17.84
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B]) Week 176, n=201	0.6 Milliseconds Standard Deviation 18.02
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B]) Week 200, n=149	3.3 Milliseconds Standard Deviation 17.02
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B]) Week 228, n=32	1.5 Milliseconds Standard Deviation 20.95
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B]) Follow up, n=270	2.5 Milliseconds Standard Deviation 18.71

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 240

Population: AT Population.

Twelve-lead ECGs were performed at Screening and every 24 weeks during the treatment period. ECG measurements were made after the participant had rested in the supine position for 5 minutes. Collection shortly after a meal or during sleep was avoided as QT prolongation can occur at these times. Baseline was the last available ECG prior to mepolizumab dosing. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.

Outcome measures

Measure	Mepolizumab 100 mg n=347 Participants Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F]) Week 24, n=330	5.1 Milliseconds Standard Deviation 17.00
Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F]) Week 48, n=319	4.1 Milliseconds Standard Deviation 15.72
Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F]) Week 72, n=307	0.2 Milliseconds Standard Deviation 15.11
Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F]) Week 96, n=293	2.2 Milliseconds Standard Deviation 15.37
Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F]) Week 124, n=292	3.2 Milliseconds Standard Deviation 16.77
Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F]) Week 148, n=275	2.9 Milliseconds Standard Deviation 15.49
Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F]) Week 176, n=201	2.0 Milliseconds Standard Deviation 15.97
Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F]) Week 200, n=149	4.3 Milliseconds Standard Deviation 14.52
Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F]) Week 228, n=32	0.4 Milliseconds Standard Deviation 15.81
Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F]) Follow up, n=270	3.9 Milliseconds Standard Deviation 16.39

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 240

Population: AT Population.

Twelve-lead ECGs were performed at Screening and every 24 weeks during the treatment period. ECG measurements were made after the participant had rested in the supine position for 5 minutes. Collection shortly after a meal or during sleep was avoided as QT prolongation can occur at these times. Baseline was the last available ECG prior to mepolizumab dosing. Change from Baseline was post-Baseline values minus Baseline values. Number of participants with a maximum change from Baseline for QTc(F) and QTc(B) at any time post Baseline are presented. Only those participants who provided ECG data at baseline and post-baseline were analyzed.

Outcome measures

Measure	Mepolizumab 100 mg n=342 Participants Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B) QTc(F): < -60	0 Participants
Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B) QTc(F): >= -60 - < -30	1 Participants
Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B) QTc(F): >= -30 - < 0	31 Participants
Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B) QTc(F): >= 0 - < 30	252 Participants
Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B) QTc(F): >= 30 - < 60	55 Participants
Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B) QTc(F): >= 60	3 Participants
Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B) QTc(B): < -60	0 Participants
Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B) QTc(B): >= -60 - < -30	1 Participants
Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B) QTc(B): >= -30 - < 0	36 Participants
Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B) QTc(B): >= 0 - < 30	228 Participants
Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B) QTc(B): >= 30 - < 60	69 Participants
Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B) QTc(B): >= 60	8 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 240

Population: AT Population.

Clinical chemistry analytes with laboratory ranges defining values of potential clinical concern included sodium, potassium, calcium, phosphate, serum glucose and alanine aminotransferase. Number of participants with clinical chemistry abnormalities of potential clinical concern anytime post baseline are presented. Only those participants who provided lab data post-baseline were analyzed represented by n=X in the category titles.

Outcome measures

Measure	Mepolizumab 100 mg n=346 Participants Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Number of Participants With Clinical Chemistry Data of Potential Clinical Concern Potassium high, n=346	1 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Concern Serum glucose high, n=346	1 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Concern Serum glucose low, n=346	7 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 240

Population: AT Population.

Hematology parameters with laboratory ranges defining values of potential clinical concern included hemoglobin, hematocrit, platelet count, white blood cell count. Number of participants with clinical hematology abnormalities of potential clinical concern anytime post baseline are presented, which only included participants with low hemoglobin values. Only those participants who provided lab data post-baseline were analyzed.

Outcome measures

Measure	Mepolizumab 100 mg n=346 Participants Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Number of Participants With Hematology Data of Potential Clinical Concern	1 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 240

Population: AT Population.

Vital signs included sitting pulse rate and sitting blood pressure (diastolic and systolic). Measurements were done pre injection with the participant sitting, having rested in this position for at least 5 minutes before each reading. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.

Outcome measures

Measure	Mepolizumab 100 mg n=347 Participants Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 4, n=346	-1.0 Millimeters of mercury (mmHg) Standard Deviation 8.71
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 8, n=345	-1.5 Millimeters of mercury (mmHg) Standard Deviation 8.85
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 12, n=342	-0.7 Millimeters of mercury (mmHg) Standard Deviation 9.67
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 16, n=341	-1.6 Millimeters of mercury (mmHg) Standard Deviation 9.27
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 20, n=338	-1.6 Millimeters of mercury (mmHg) Standard Deviation 9.17
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 24, n=336	-0.7 Millimeters of mercury (mmHg) Standard Deviation 9.27
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 28, n=332	-1.3 Millimeters of mercury (mmHg) Standard Deviation 8.90
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 32, n=333	-1.0 Millimeters of mercury (mmHg) Standard Deviation 9.62
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 36, n=329	-1.8 Millimeters of mercury (mmHg) Standard Deviation 8.95
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 40, n=329	-1.2 Millimeters of mercury (mmHg) Standard Deviation 9.33
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 44, n=326	-1.1 Millimeters of mercury (mmHg) Standard Deviation 10.00
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 48, n=325	-0.7 Millimeters of mercury (mmHg) Standard Deviation 9.67
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 52, n=322	-1.1 Millimeters of mercury (mmHg) Standard Deviation 9.85
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 56, n=320	-1.3 Millimeters of mercury (mmHg) Standard Deviation 9.67
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 60, n=318	-0.9 Millimeters of mercury (mmHg) Standard Deviation 9.56
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 64, n=318	-1.0 Millimeters of mercury (mmHg) Standard Deviation 9.29
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 68, n=317	-1.1 Millimeters of mercury (mmHg) Standard Deviation 9.94
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 72, n=312	-1.5 Millimeters of mercury (mmHg) Standard Deviation 9.67
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 76, n=313	-1.1 Millimeters of mercury (mmHg) Standard Deviation 10.06
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 80, n=311	-1.6 Millimeters of mercury (mmHg) Standard Deviation 10.23
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 84, n=310	-1.7 Millimeters of mercury (mmHg) Standard Deviation 10.51
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 88, n=310	-1.4 Millimeters of mercury (mmHg) Standard Deviation 10.45
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 92, n=311	-1.0 Millimeters of mercury (mmHg) Standard Deviation 9.89
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 96, n=303	-1.2 Millimeters of mercury (mmHg) Standard Deviation 9.81
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 100, n=300	-0.3 Millimeters of mercury (mmHg) Standard Deviation 9.40
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 104, n=301	-1.0 Millimeters of mercury (mmHg) Standard Deviation 9.69
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 108, n=300	-0.9 Millimeters of mercury (mmHg) Standard Deviation 10.28
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 112, n=299	-0.9 Millimeters of mercury (mmHg) Standard Deviation 9.78
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 116, n=297	-0.7 Millimeters of mercury (mmHg) Standard Deviation 9.56
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 120, n=295	-0.8 Millimeters of mercury (mmHg) Standard Deviation 9.41
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 124, n=294	-1.3 Millimeters of mercury (mmHg) Standard Deviation 10.52
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 128, n=293	-1.2 Millimeters of mercury (mmHg) Standard Deviation 10.08
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 132, n=289	-1.0 Millimeters of mercury (mmHg) Standard Deviation 10.48
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 136, n=288	-0.7 Millimeters of mercury (mmHg) Standard Deviation 10.42
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 140, n=287	-0.6 Millimeters of mercury (mmHg) Standard Deviation 9.90
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 144, n=290	-0.9 Millimeters of mercury (mmHg) Standard Deviation 9.83
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 148, n=287	0.1 Millimeters of mercury (mmHg) Standard Deviation 10.22
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 152, n=284	-0.9 Millimeters of mercury (mmHg) Standard Deviation 10.17
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 156, n=275	-0.4 Millimeters of mercury (mmHg) Standard Deviation 10.44
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 160, n=265	-0.6 Millimeters of mercury (mmHg) Standard Deviation 9.93
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 164, n=242	-1.7 Millimeters of mercury (mmHg) Standard Deviation 10.83
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 168, n=232	-1.3 Millimeters of mercury (mmHg) Standard Deviation 10.46
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 172, n=226	-1.2 Millimeters of mercury (mmHg) Standard Deviation 10.18
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 176, n=212	-1.6 Millimeters of mercury (mmHg) Standard Deviation 9.84
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 180, n=200	-1.6 Millimeters of mercury (mmHg) Standard Deviation 10.42
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 184, n=184	-1.3 Millimeters of mercury (mmHg) Standard Deviation 9.94
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 188, n=180	-1.4 Millimeters of mercury (mmHg) Standard Deviation 9.81
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 192, n=176	-1.1 Millimeters of mercury (mmHg) Standard Deviation 10.25
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 196, n=175	-1.5 Millimeters of mercury (mmHg) Standard Deviation 10.18
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 200, n=172	-0.4 Millimeters of mercury (mmHg) Standard Deviation 10.07
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 204, n=169	-1.1 Millimeters of mercury (mmHg) Standard Deviation 10.25
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 208, n=157	-1.8 Millimeters of mercury (mmHg) Standard Deviation 9.48
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 212, n=146	-1.3 Millimeters of mercury (mmHg) Standard Deviation 9.53
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 216, n=130	-0.2 Millimeters of mercury (mmHg) Standard Deviation 9.55
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 220, n=67	-1.6 Millimeters of mercury (mmHg) Standard Deviation 10.85
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 224, n=54	-1.9 Millimeters of mercury (mmHg) Standard Deviation 11.97
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 228, n=37	-0.2 Millimeters of mercury (mmHg) Standard Deviation 9.60
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Week 232, n=5	4.6 Millimeters of mercury (mmHg) Standard Deviation 5.86
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Diastolic Blood Pressure: Follow-up, n=306	-0.7 Millimeters of mercury (mmHg) Standard Deviation 10.03
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 4, n=346	0.2 Millimeters of mercury (mmHg) Standard Deviation 10.79
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 8, n=345	-0.7 Millimeters of mercury (mmHg) Standard Deviation 12.57
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 12, n=342	-0.3 Millimeters of mercury (mmHg) Standard Deviation 12.59
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 16, n=341	-0.5 Millimeters of mercury (mmHg) Standard Deviation 13.60
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 20, n=338	-1.8 Millimeters of mercury (mmHg) Standard Deviation 13.31
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 24, n=336	-0.8 Millimeters of mercury (mmHg) Standard Deviation 13.93
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 28, n=332	-0.6 Millimeters of mercury (mmHg) Standard Deviation 13.61
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 32, n=333	-1.0 Millimeters of mercury (mmHg) Standard Deviation 14.24
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 36, n=329	-0.7 Millimeters of mercury (mmHg) Standard Deviation 14.19
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 40, n=329	-0.6 Millimeters of mercury (mmHg) Standard Deviation 14.11
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 44, n=326	-0.9 Millimeters of mercury (mmHg) Standard Deviation 14.87
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 48, n=325	-0.1 Millimeters of mercury (mmHg) Standard Deviation 13.59
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 52, n=322	-0.3 Millimeters of mercury (mmHg) Standard Deviation 13.63
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 56, n=320	-0.3 Millimeters of mercury (mmHg) Standard Deviation 14.33
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 60, n=318	-0.0 Millimeters of mercury (mmHg) Standard Deviation 14.21
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 64, n=318	-0.2 Millimeters of mercury (mmHg) Standard Deviation 13.99
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 68, n=317	-1.1 Millimeters of mercury (mmHg) Standard Deviation 14.83
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 72, n=312	-1.8 Millimeters of mercury (mmHg) Standard Deviation 13.16
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 76, n=313	-0.8 Millimeters of mercury (mmHg) Standard Deviation 14.44
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 80, n=311	-1.1 Millimeters of mercury (mmHg) Standard Deviation 14.49
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 84, n=310	-1.9 Millimeters of mercury (mmHg) Standard Deviation 14.47
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 88, n=310	-1.7 Millimeters of mercury (mmHg) Standard Deviation 14.94
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 92, n=311	-0.3 Millimeters of mercury (mmHg) Standard Deviation 15.16
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 96, n=303	0.1 Millimeters of mercury (mmHg) Standard Deviation 14.32
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 100, n=300	0.7 Millimeters of mercury (mmHg) Standard Deviation 14.71
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 104, n=301	0.3 Millimeters of mercury (mmHg) Standard Deviation 14.81
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 108, n=300	0.5 Millimeters of mercury (mmHg) Standard Deviation 15.15
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 112, n=299	-0.4 Millimeters of mercury (mmHg) Standard Deviation 14.83
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 116, n=297	0.4 Millimeters of mercury (mmHg) Standard Deviation 14.31
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 120, n=295	0.5 Millimeters of mercury (mmHg) Standard Deviation 14.37
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 124, n=294	0.7 Millimeters of mercury (mmHg) Standard Deviation 14.80
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 128, n=293	0.7 Millimeters of mercury (mmHg) Standard Deviation 14.68
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 132, n=289	0.7 Millimeters of mercury (mmHg) Standard Deviation 14.51
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 136, n=288	0.9 Millimeters of mercury (mmHg) Standard Deviation 16.81
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 140, n=287	0.3 Millimeters of mercury (mmHg) Standard Deviation 15.48
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 144, n=290	1.1 Millimeters of mercury (mmHg) Standard Deviation 15.79
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 148, n=287	1.8 Millimeters of mercury (mmHg) Standard Deviation 13.59
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 152, n=284	0.2 Millimeters of mercury (mmHg) Standard Deviation 15.53
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 156, n=275	0.8 Millimeters of mercury (mmHg) Standard Deviation 14.56
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 160, n=265	1.1 Millimeters of mercury (mmHg) Standard Deviation 15.34
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 164, n=242	0.6 Millimeters of mercury (mmHg) Standard Deviation 15.51
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 168, n=232	0.1 Millimeters of mercury (mmHg) Standard Deviation 14.87
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 172, n=226	-0.8 Millimeters of mercury (mmHg) Standard Deviation 15.67
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 176, n=212	0.4 Millimeters of mercury (mmHg) Standard Deviation 13.78
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 180, n=200	0.6 Millimeters of mercury (mmHg) Standard Deviation 15.32
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 184, n=184	-0.5 Millimeters of mercury (mmHg) Standard Deviation 16.36
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 188, n=180	-1.0 Millimeters of mercury (mmHg) Standard Deviation 15.54
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 192, n=176	-1.2 Millimeters of mercury (mmHg) Standard Deviation 16.60
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 196, n=175	-0.8 Millimeters of mercury (mmHg) Standard Deviation 14.76
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 200, n=172	-0.1 Millimeters of mercury (mmHg) Standard Deviation 15.28
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 204, n=169	-0.4 Millimeters of mercury (mmHg) Standard Deviation 15.64
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 208, n=157	-1.0 Millimeters of mercury (mmHg) Standard Deviation 16.92
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 212, n=146	0.5 Millimeters of mercury (mmHg) Standard Deviation 14.98
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 216, n=130	0.4 Millimeters of mercury (mmHg) Standard Deviation 15.52
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 220, n=67	-4.2 Millimeters of mercury (mmHg) Standard Deviation 20.86
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 224, n=54	-3.8 Millimeters of mercury (mmHg) Standard Deviation 17.87
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 228, n=37	-3.6 Millimeters of mercury (mmHg) Standard Deviation 15.15
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Week 232, n=5	-0.8 Millimeters of mercury (mmHg) Standard Deviation 6.30
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure Sitting Systolic Blood Pressure: Follow-up, n=306	-0.0 Millimeters of mercury (mmHg) Standard Deviation 14.92

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 240

Population: AT Population.

Vital signs included sitting pulse rate and blood pressure (diastolic and systolic). Measurements were done pre injection with the participant sitting, having rested in this position for at least 5 minutes before each reading. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.

Outcome measures

Measure	Mepolizumab 100 mg n=347 Participants Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 4, n=346	-0.3 Beats per minute Standard Deviation 8.94
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 8, n=345	1.0 Beats per minute Standard Deviation 9.98
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 12, n=342	0.0 Beats per minute Standard Deviation 9.52
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 16, n=341	-0.1 Beats per minute Standard Deviation 10.08
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 20, n=338	-0.3 Beats per minute Standard Deviation 9.44
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 24, n=337	-1.6 Beats per minute Standard Deviation 9.83
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 28, n=332	-0.2 Beats per minute Standard Deviation 9.58
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 32, n=333	-0.2 Beats per minute Standard Deviation 9.74
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 36, n=329	-0.6 Beats per minute Standard Deviation 9.60
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 40, n=329	-0.2 Beats per minute Standard Deviation 9.56
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 44, n=327	-0.4 Beats per minute Standard Deviation 9.80
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 48, n=325	-1.6 Beats per minute Standard Deviation 9.65
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 52, n=322	0.1 Beats per minute Standard Deviation 9.56
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 56, n=320	-0.3 Beats per minute Standard Deviation 9.79
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 60, n=318	-0.8 Beats per minute Standard Deviation 9.54
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 64, n=318	-0.9 Beats per minute Standard Deviation 9.63
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 68, n=317	-1.2 Beats per minute Standard Deviation 9.51
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 72, n=312	-1.8 Beats per minute Standard Deviation 10.07
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 76, n=313	-1.2 Beats per minute Standard Deviation 9.65
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 80, n=311	-0.5 Beats per minute Standard Deviation 10.08
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 84, n=310	-1.2 Beats per minute Standard Deviation 9.80
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 88, n=310	-0.6 Beats per minute Standard Deviation 10.12
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 92, n=311	-0.6 Beats per minute Standard Deviation 9.36
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 96, n=303	-1.7 Beats per minute Standard Deviation 10.61
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 100, n=300	-0.5 Beats per minute Standard Deviation 9.81
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 104, n=301	-0.9 Beats per minute Standard Deviation 10.45
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 108, n=300	-0.8 Beats per minute Standard Deviation 10.04
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 112, n=299	-0.5 Beats per minute Standard Deviation 9.60
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 116, n=297	-1.5 Beats per minute Standard Deviation 9.33
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 120, n=294	-1.2 Beats per minute Standard Deviation 10.27
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 124, n=294	-2.5 Beats per minute Standard Deviation 10.27
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 128, n=293	-1.2 Beats per minute Standard Deviation 10.00
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 132, n=289	-0.7 Beats per minute Standard Deviation 9.20
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 136, n=288	-0.6 Beats per minute Standard Deviation 10.55
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 140, n=287	-0.6 Beats per minute Standard Deviation 9.71
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 144, n=290	-0.7 Beats per minute Standard Deviation 9.72
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 148, n=287	-1.8 Beats per minute Standard Deviation 9.82
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 152, n=284	-0.9 Beats per minute Standard Deviation 10.45
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 156, n=275	-0.8 Beats per minute Standard Deviation 9.83
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 160, n=265	-0.5 Beats per minute Standard Deviation 10.42
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 164, n=242	-1.1 Beats per minute Standard Deviation 11.07
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 168, n=232	-0.5 Beats per minute Standard Deviation 11.25
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 172, n=226	-1.0 Beats per minute Standard Deviation 9.80
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 176, n=212	-2.9 Beats per minute Standard Deviation 9.57
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 180, n=200	-0.5 Beats per minute Standard Deviation 10.01
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 184, n=184	-1.3 Beats per minute Standard Deviation 9.89
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 188, n=180	-1.3 Beats per minute Standard Deviation 10.38
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 192, n=176	-1.6 Beats per minute Standard Deviation 10.37
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 196, n=175	-1.2 Beats per minute Standard Deviation 9.79
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 200, n=172	-2.3 Beats per minute Standard Deviation 11.03
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 204, n=169	-1.9 Beats per minute Standard Deviation 10.67
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 208, n=157	-0.6 Beats per minute Standard Deviation 10.64
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 212, n=146	-0.4 Beats per minute Standard Deviation 10.09
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 216, n=130	-1.4 Beats per minute Standard Deviation 10.49
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 220, n=67	-0.0 Beats per minute Standard Deviation 11.13
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 224, n=54	-1.4 Beats per minute Standard Deviation 13.19
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 228, n=37	-2.4 Beats per minute Standard Deviation 10.57
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Week 232, n=5	-2.0 Beats per minute Standard Deviation 16.63
Mean Change From Baseline in Vital Signs-Sitting Pulse Rate Sitting Pulse Rate: Follow-up, n=306	-1.5 Beats per minute Standard Deviation 10.72

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 240

Population: AT Population.

Exacerbations were defined as worsening of asthma which required use of systemic corticosteroids and/or hospitalization and/or Emergency Department visits. Data is presented as mean which is exacerbation rate/year. Exacerbation data are performed using a negative binomial model with covariates of region, annualized rate of exacerbations in the interval between MEA112997 and MEA115666 (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.

Outcome measures

Measure	Mepolizumab 100 mg n=347 Participants Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Annualized Rate of On-treatment Exacerbations	0.68 Exacerbations per year Interval 0.6 to 0.78

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 240

Population: AT Population.

The ACQ-5 is a five-item questionnaire, which was developed as a measure of participant' asthma control that was completed by the participant. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze). The ACQ consists of 5 questions that are scored on a 7 point scale from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ score was derived as mean of five questions: ACQ score = Question 1 (Q1)+Q2+Q3+Q4+Q5 divided by 5 where Q1, Q2,... Q5 are the scores of Q1, Q2, ..., Q5, respectively. The total score ranged from zero (no impairment/limitation) which indicated best condition to six (total impairment/ limitation) which indicated worst asthma. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.

Outcome measures

Measure	Mepolizumab 100 mg n=347 Participants Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 12, n=341	-0.47 Scores on a Scale Standard Deviation 0.991
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 24, n=335	-0.55 Scores on a Scale Standard Deviation 1.037
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 36, n=327	-0.56 Scores on a Scale Standard Deviation 1.088
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 48, n=324	-0.55 Scores on a Scale Standard Deviation 1.098
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 60, n=317	-0.58 Scores on a Scale Standard Deviation 1.126
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 72, n=311	-0.51 Scores on a Scale Standard Deviation 1.054
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 84, n=308	-0.54 Scores on a Scale Standard Deviation 1.090
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 96, n=301	-0.44 Scores on a Scale Standard Deviation 1.171
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 112, n=297	-0.51 Scores on a Scale Standard Deviation 1.228
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 124, n=293	-0.66 Scores on a Scale Standard Deviation 1.216
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 136, n=287	-0.58 Scores on a Scale Standard Deviation 1.215
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 148, n=286	-0.54 Scores on a Scale Standard Deviation 1.070
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 164, n=240	-0.59 Scores on a Scale Standard Deviation 1.221
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 176, n=211	-0.49 Scores on a Scale Standard Deviation 1.179
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 188, n=178	-0.40 Scores on a Scale Standard Deviation 1.310
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 200, n=171	-0.45 Scores on a Scale Standard Deviation 1.119
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 216, n=130	-0.42 Scores on a Scale Standard Deviation 1.161
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Week 228, n=37	-0.47 Scores on a Scale Standard Deviation 1.502
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Follow-up, n=301	-0.53 Scores on a Scale Standard Deviation 1.193

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 240

Population: AT Population.

FEV1 is forced expiratory volume in the first second. The volume of air that can be forced out in one second after taking a deep breath, an important measure of pulmonary function. Forced expiratory volume (FEV) measures how much air a person can exhale during a forced breath. FEV1 was measured by clinic spirometry. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.

Outcome measures

Measure	Mepolizumab 100 mg n=347 Participants Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Week 12, n=340	124 Milliliters (mL) Standard Deviation 346.9
Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Week 24, n=334	144 Milliliters (mL) Standard Deviation 335.0
Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Week 48, n=325	98 Milliliters (mL) Standard Deviation 395.2
Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Week 72, n=312	91 Milliliters (mL) Standard Deviation 405.5
Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Week 96, n=301	51 Milliliters (mL) Standard Deviation 385.8
Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Week 124, n=292	85 Milliliters (mL) Standard Deviation 395.5
Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Week 148, n=281	17 Milliliters (mL) Standard Deviation 370.2
Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Week 176, n=210	45 Milliliters (mL) Standard Deviation 352.2
Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Week 200, n=171	8 Milliliters (mL) Standard Deviation 375.7
Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Week 228, n=37	-23 Milliliters (mL) Standard Deviation 331.9

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 240

Population: AT Population.

Immunogenicity testing included two types of assays: a binding antibody assay (anti-drug antibody; ADA) and a neutralizing antibody (NAb) assay for participants who were tested positive in the ADA assay. Blood samples were collected for the determination of anti-mepolizumab antibodies, just prior to administration of mepolizumab. Samples that test positive for anti-mepolizumab antibodies were further tested for the presence of neutralizing antibody. Number of participants with positive highest value post-Baseline have been presented. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.

Outcome measures

Measure	Mepolizumab 100 mg n=347 Participants Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Number of Participants With Positive Anti-mepolizumab Binding Antibodies (ADA) and Neutralizing Antibodies (NAb) Positive ADA result, n=346	27 Participants
Number of Participants With Positive Anti-mepolizumab Binding Antibodies (ADA) and Neutralizing Antibodies (NAb) Positive NAb result, n=27	0 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 240

Population: AT Population.

Lack of efficacy referred to failure of expected pharmacological action of Mepolizumab. Number of participants who withdrew due to lack of efficacy are presented.

Outcome measures

Measure	Mepolizumab 100 mg n=347 Participants Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Number of Participants Who Withdrew Due to Lack of Efficacy	11 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 240

Population: AT Population.

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Number of participants requiring hospitalization due to an on-treatment serious adverse event including asthma exacerbations are presented. On-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days.

Outcome measures

Measure	Mepolizumab 100 mg n=347 Participants Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Number of Participants Requiring Hospitalizations Due to Adverse Events Including Asthma Exacerbations	71 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 240

Population: AT Population.

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Number of participants who withdrew due to AE are presented.

Outcome measures

Measure	Mepolizumab 100 mg n=347 Participants Participants received 100 mg of mepolizumab injected SC once every 4 weeks until participant withdrawal or mepolizumab becomes commercially available in the relevant participating country. Participants remained on standard of care asthma therapy, which was adjusted during the study, at the discretion of their physician.
Number of Participants Who Withdrew Due to AE	19 Participants

Adverse Events

Mepolizumab

Serious events: 79 serious events

Other events: 314 other events

Deaths: 6 deaths

Serious adverse events

Measure	Mepolizumab n=347 participants at risk Subjects will receive 100 mg of mepolizumab (in 1ml polypropylene syringe) injected subcutaneously (SC) approximately every 4 weeks.
Renal and urinary disorders Renal colic	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Renal and urinary disorders Urinary incontinence	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Reproductive system and breast disorders Cervical polyp	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Reproductive system and breast disorders Rectocele	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Blood and lymphatic system disorders Lymphocytosis	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Endocrine disorders Basedow's disease	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Endocrine disorders Thyroid mass	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Metabolism and nutrition disorders Obesity	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Respiratory, thoracic and mediastinal disorders Asthma	9.5% 33/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Pneumonia	1.7% 6/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Cellulitis	0.58% 2/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Respiratory tract infection	0.58% 2/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Abscess limb	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Anal abscess	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Gastroenteritis	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Herpes zoster	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Influenza	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Lower respiratory tract infection	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Myelitis	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Postoperative wound infection	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Pyelonephritis	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Staphylococcal infection	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Streptococcal infection	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Urinary tract infection	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Abdominal pain	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Abdominal pain upper	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Chronic gastritis	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Colitis	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Constipation	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Diverticulum intestinal	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Faecaloma	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Gastric polyps	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Incarcerated inguinal hernia	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Inguinal hernia	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Large intestinal obstruction	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Umbilical hernia	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Musculoskeletal and connective tissue disorders Bursitis	0.58% 2/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.58% 2/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Musculoskeletal and connective tissue disorders Back pain	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Cardiac disorders Acute myocardial infarction	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Cardiac disorders Angina unstable	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Cardiac disorders Atrial fibrillation	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Cardiac disorders Atrial flutter	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Cardiac disorders Atrial tachycardia	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Cardiac disorders Cardiac failure acute	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Cardiac disorders Myocardial infarction	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Injury, poisoning and procedural complications Comminuted fracture	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Injury, poisoning and procedural complications Femur fracture	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Injury, poisoning and procedural complications Joint dislocation	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Injury, poisoning and procedural complications Ligament rupture	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Injury, poisoning and procedural complications Ligament sprain	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Injury, poisoning and procedural complications Tendon rupture	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Nervous system disorders Epilepsy	0.58% 2/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Nervous system disorders Sciatica	0.58% 2/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Nervous system disorders Cerebral haemorrhage	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Nervous system disorders Dizziness	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Nervous system disorders Peroneal nerve palsy	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Nervous system disorders Spinal claudication	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Nervous system disorders Syncope	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.58% 2/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
General disorders Chills	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
General disorders Non-cardiac chest pain	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
General disorders Sudden death	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Hepatobiliary disorders Cholelithiasis	0.58% 2/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Hepatobiliary disorders Cholestasis	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Hepatobiliary disorders Hepatocellular injury	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Vascular disorders Hypertension	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Vascular disorders Hypertensive crisis	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Vascular disorders Thrombophlebitis superficial	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Immune system disorders Anaphylactic reaction	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Immune system disorders Anaphylactic shock	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Investigations Blood glucose increased	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Investigations Hepatic enzyme increased	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Renal and urinary disorders Bladder prolapse	0.29% 1/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.

Other adverse events

Measure	Mepolizumab n=347 participants at risk Subjects will receive 100 mg of mepolizumab (in 1ml polypropylene syringe) injected subcutaneously (SC) approximately every 4 weeks.
Infections and infestations Viral upper respiratory tract infection	48.7% 169/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Upper respiratory tract infection	23.3% 81/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Bronchitis	21.0% 73/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Sinusitis	16.4% 57/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Influenza	12.4% 43/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Respiratory tract infection	11.0% 38/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Lower respiratory tract infection	8.9% 31/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Gastroenteritis	7.8% 27/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Pharyngitis	6.9% 24/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Urinary tract infection	6.9% 24/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Rhinitis	6.6% 23/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Respiratory tract infection viral	5.8% 20/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Viral infection	5.2% 18/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Ear infection	4.3% 15/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Acute sinusitis	4.0% 14/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Cystitis	3.7% 13/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Nasopharyngitis	3.7% 13/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Infections and infestations Oral candidiasis	3.7% 13/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Respiratory, thoracic and mediastinal disorders Asthma	19.9% 69/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	10.4% 36/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.8% 27/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Respiratory, thoracic and mediastinal disorders Cough	6.3% 22/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Respiratory, thoracic and mediastinal disorders Productive cough	3.5% 12/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	3.5% 12/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Respiratory, thoracic and mediastinal disorders Dysphonia	3.2% 11/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.2% 11/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Musculoskeletal and connective tissue disorders Back pain	18.2% 63/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 58/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Musculoskeletal and connective tissue disorders Pain in extremity	11.5% 40/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Musculoskeletal and connective tissue disorders Osteoarthritis	5.8% 20/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Musculoskeletal and connective tissue disorders Myalgia	5.2% 18/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.0% 14/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Nervous system disorders Headache	28.5% 99/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Nervous system disorders Dizziness	6.6% 23/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Nervous system disorders Sciatica	4.6% 16/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Diarrhoea	7.5% 26/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Toothache	6.3% 22/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Abdominal pain	4.9% 17/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Nausea	4.9% 17/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Abdominal pain upper	4.3% 15/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Gastrooesophageal reflux disease	4.0% 14/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Dyspepsia	3.5% 12/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Gastrointestinal disorders Vomiting	3.2% 11/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
General disorders Injection site reaction	12.1% 42/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
General disorders Fatigue	3.5% 12/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Injury, poisoning and procedural complications Laceration	4.3% 15/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Injury, poisoning and procedural complications Contusion	3.7% 13/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Injury, poisoning and procedural complications Ligament sprain	3.2% 11/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Vascular disorders Hypertension	9.2% 32/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Eye disorders Cataract	4.0% 14/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Immune system disorders Hypersensitivity	3.7% 13/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Skin and subcutaneous tissue disorders Rash	3.5% 12/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.
Metabolism and nutrition disorders Hypercholesterolaemia	3.2% 11/347 • The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks) AE and SAE were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER