Trial Outcomes & Findings for An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE) (NCT NCT02736409)

Results Overview

Relapse (Yes/No) was defined as meeting both the eosinophil histology relapse criterion and the dysphagia symptom relapse criterion. Eosinophil histology relapse was defined as an eosinophil count of greater than or equal to(\> or =) 15 per high-power field (eos/hpf) from at least 2 of 3 levels of the esophagus. Dysphagia symptom relapse was defined as having at least 4 days of dysphagia (with answer 'Yes' for question 2 in DSQ \[Dysphagia Symptom Questionnaire\]) in the 2-week period prior to the scheduled visit, as determined by the DSQ.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

219 participants

Primary outcome timeframe

Week 36

Results posted on

2025-02-19

Participant Flow

This study was conducted at 70 sites in United States from 01 April 2016 (first participant enrolled) to 12 November 2019 (last participant completed).

A total of 219 participants who completed the study SHP621-301 (NCT02605837) and consented to participate in the current study SHP621-302 (NCT02736409) were enrolled and received at least one dose of investigational product (IP), among which 174 participants completed this study .

Participant milestones

Participant milestones
Measure	Full Responder BOS-PBO Group Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Overall Study STARTED	23	25	106	65
Overall Study COMPLETED	19	22	80	53
Overall Study NOT COMPLETED	4	3	26	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Full Responder BOS-PBO Group Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Overall Study Withdrawal by Subject	4	2	17	3
Overall Study Non-Compliance with Study Drug	0	0	0	1
Overall Study Adverse Event	0	1	5	4
Overall Study Other	0	0	1	1
Overall Study Pregnancy	0	0	1	0
Overall Study Lost to Follow-up	0	0	2	1
Overall Study Physician Decision	0	0	0	2

Baseline Characteristics

An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Total n=219 Participants Total of all reporting groups
Age, Continuous	36.1 Years STANDARD_DEVIATION 11.66 • n=5 Participants	36.8 Years STANDARD_DEVIATION 14.09 • n=7 Participants	33.1 Years STANDARD_DEVIATION 12.02 • n=5 Participants	33.5 Years STANDARD_DEVIATION 12.61 • n=4 Participants	34.0 Years STANDARD_DEVIATION 12.40 • n=21 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	11 Participants n=7 Participants	42 Participants n=5 Participants	26 Participants n=4 Participants	86 Participants n=21 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	14 Participants n=7 Participants	64 Participants n=5 Participants	39 Participants n=4 Participants	133 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	25 Participants n=7 Participants	101 Participants n=5 Participants	62 Participants n=4 Participants	211 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	24 Participants n=7 Participants	95 Participants n=5 Participants	62 Participants n=4 Participants	203 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 36

Population: SHP621-301 (NCT02605837) BOS Full Responder FAS consisted of all randomized participants who were determined to be Full responders to the BOS treatment during the induction study SHP621-301 (NCT02605837) and who received at least 1 dose of IP in the SHP621-302 (NCT02736409) study.

Relapse (Yes/No) was defined as meeting both the eosinophil histology relapse criterion and the dysphagia symptom relapse criterion. Eosinophil histology relapse was defined as an eosinophil count of greater than or equal to(\> or =) 15 per high-power field (eos/hpf) from at least 2 of 3 levels of the esophagus. Dysphagia symptom relapse was defined as having at least 4 days of dysphagia (with answer 'Yes' for question 2 in DSQ \[Dysphagia Symptom Questionnaire\]) in the 2-week period prior to the scheduled visit, as determined by the DSQ.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Proportion of Participants Who Had Relapse During the Entire Week 36 Period	0.43 proportion of participants	0.24 proportion of participants	—	—

SECONDARY outcome

Timeframe: Week 36

Population: SHP621-301 (NCT02605837) BOS Non responder FAS included all randomized participants who did not respond or partially responded to assigned BOS treatment in the induction study SHP621-301 (NCT02605837) and who received at least 1 dose of IP in the SHP621-302 (NCT02736409) study.

Long-term response from SHP621-301 baseline defined: histologic response,defined as peak eosinophil count of less than or equal to(\< or =)6/HPF across all available esophageal levels at Week 36 and Dysphagia symptom response 1,defined as \>or= 30 percent(%) reduction in DSQ combined score(Questions \[Q\] 2+3) from baseline of SHP621-301 to Week 36.DSQcontain 4 questions,all participants used diary,responded to Q1(didyoueatsolid food),Q2(did food pass slowly or get stuck). If participant's answer to Q2 was No,diary ended for day. If participant answered Yes,he/she advanced to Q3(didyouhavetodoanything to make food go downorget relief), Q4(extent to which participant experienced pain while swallowing).DSQ combined score= (\[sum of points from Q2+3 in daily DSQ\]×14)/Number of diaries reported with non-missing data.Scale range was0-2 forQ2 and 0-4 forQ 3.Scale range for DSQ combined score was 0-84.Highervaluesrepresentingworseoutcome.Negative change from baseline indicates symptoms decreased.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=106 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Proportion of Participants With Long-term Treatment Response From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 36 of Current Study	0.13 proportion of participants	—	—	—

SECONDARY outcome

Timeframe: Week 36

Population: SHP621-301 (NCT02605837) BOS Non responder FAS included all randomized participants who did not respond or partially responded to assigned BOS treatment in the induction study SHP621-301 (NCT02605837) and who received at least 1 dose of IP in the SHP621-302 (NCT02736409) study.

Long-term response from baseline defined: histologic response, defined as peak eosinophil count of less than or equal to(\< or =) 6/HPF across all available esophageal levels at Week 36 and Dysphagia symptom response 1,defined as \>or= 30 percent(%) reduction in DSQ combined score (Questions \[Q\] 2+3) from baseline of SHP621-301 to Week 36.DSQcontain 4 questions,all participants used diary,responded to Q1(did you eat solid food),Q2(did food pass slowly or get stuck). If participant's answer to Q2 was No,diary ended for day. If participant answered Yes,he/she advanced to Q3(didyouhavetodoanything to make food go downorget relief), Q4(extent to which participant experienced pain while swallowing).DSQ combined score= (\[sum of points from Q2+3 in daily DSQ\]×14)/Number of diaries reported with non-missing data.Scale range was0-2 forQ2 and 0-4 forQ 3.Scale range for DSQ combined score was 0-84. Higher values representing worse outcome.Negative change from baseline indicates symptoms decreased.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=106 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Proportion of Participants With Long-term Treatment Response From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 36	0.06 proportion of participants	—	—	—

SECONDARY outcome

Timeframe: Week 12 and Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study.

Histology response was defined as a peak eosinophil count of \<or=6/HPF across all available levels at Week 12 and Week 36.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Proportion of Participants Who Had a Histologic Response (Eosinophil Count of Less Than or Equal to (<or=6)/High-Powered Field [HPF]) at Week 12 and Week 36 Week 12	0.04 proportion of participants	0.76 proportion of participants	0.27 proportion of participants	0.57 proportion of participants
Proportion of Participants Who Had a Histologic Response (Eosinophil Count of Less Than or Equal to (<or=6)/High-Powered Field [HPF]) at Week 12 and Week 36 Week 36	0.30 proportion of participants	0.52 proportion of participants	0.21 proportion of participants	0.38 proportion of participants

SECONDARY outcome

Timeframe: Baseline of SHP621-301 (NCT02605837), Week 12 and Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study.

Dysphagia symptom response with respect to the baseline of induction study (SHP621-301 \[NCT02605837\]) was defined as 30% reduction in DSQ combined score (questions 2+3) at Week 12 and Week 36 of current study from baseline of the induction study. DSQ contain 4 questions, all participants used a diary and responded to Q1 (did you eat solid food), Q2 (did food pass slowly or get stuck). If participant's answer to Q2 was No, then diary ended for that day. If participant answered Yes,he/she advanced to Q3 (did you have to do anything to make food go down or get relief) and Q4 (extent to which participant experienced pain while swallowing). DSQ combined score= (\[sum of points from Q2+3 in daily DSQ\] × 14)/Number of diaries reported with non-missing data. Scale range was 0-2 for Q2 and 0-4 for Q3. Scale range for DSQ combined score was 0-84. Higher values representing worse outcome. Negative change from baseline indicates symptoms decreased.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Proportion of Participants Who Had at Least a 30 Percent (%) Change in DSQ Combined Score From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 12 and Week 36 Week 12	0.74 proportion of participants	0.84 proportion of participants	0.47 proportion of participants	0.57 proportion of participants
Proportion of Participants Who Had at Least a 30 Percent (%) Change in DSQ Combined Score From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 12 and Week 36 Week 36	0.78 proportion of participants	0.84 proportion of participants	0.46 proportion of participants	0.58 proportion of participants

SECONDARY outcome

Timeframe: Baseline of Current Study (SHP621-302 [NCT02736409]), Week 12 and Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study.

Dysphagia symptom response with respect to the baseline of current study (SHP621-302 \[NCT02736409\]) was defined as 30% reduction in DSQ combined score (questions 2+3) at Week 12 and Week 36 from baseline of the current study. DSQ contain 4 questions, all participants used diary and responded to Q1 (did you eat solid food), Q2 (did food pass slowly or get stuck). If participant's answer to Q2 was "No", then diary ended for that day. If participant answered "Yes",he/she advanced to Q3 (did you have to do anything to make food go down or get relief) and Q4 (extent to which participant experienced pain while swallowing). DSQ combined score= (\[sum of points from Q2+3 in daily DSQ\] × 14)/Number of diaries reported with non-missing data. Scale range was 0-2 for Q2 and 0-4 for Q 3. Scale range for DSQ combined score was 0-84. Higher values representing a worse outcome. A Negative change from baseline indicates symptoms decreased.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Proportion of Participants Who Had at Least a 30 Percent (%) Change in DSQ Combined Score From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 12 and Week 36 Week 12	0.13 proportion of participants	0.44 proportion of participants	0.24 proportion of participants	0.43 proportion of participants
Proportion of Participants Who Had at Least a 30 Percent (%) Change in DSQ Combined Score From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 12 and Week 36 Week 36	0.39 proportion of participants	0.40 proportion of participants	0.25 proportion of participants	0.42 proportion of participants

SECONDARY outcome

Timeframe: Baseline of induction study (SHP621-301 [NCT02605837]), Week 12 and Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who had an evaluable Induction Study (SHP621-301 \[NCT02605837\]) baseline and assessment at specific category/time point.

Endoscopic findings with separate evaluations of the proximal and distal esophagus were recorded with respect to 5 categories: 1) exudates or plaques (grade 0-2); 2) fixed esophageal rings (grade 0-3); 3) edema (grade 0-2); 4) furrows (grade 0-2); and 5) strictures (grade 0-1). An endoscopy score for each category was calculated and summed for each anatomic location (proximal and distal). The minimum and maximum endoscopy score was 0 and 10 points respectively for each location (proximal and distal) and the total endoscopy score was the sum of the scores for the proximal and distal locations (maximum total score of 20 points respectively). The higher score indicated worse appearance. A negative change from baseline indicates that appearance improved.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Change From Induction Study (SHP621-301 [NCT02605837]) Baseline in Total Endoscopy Score at Week 12 and Week 36 of Current Study Week 12	-1.9 Score on scale Standard Error 0.51	-5.3 Score on scale Standard Error 0.69	-3.8 Score on scale Standard Error 0.43	-4.7 Score on scale Standard Error 0.46
Change From Induction Study (SHP621-301 [NCT02605837]) Baseline in Total Endoscopy Score at Week 12 and Week 36 of Current Study Week 36	-2.7 Score on scale Standard Error 0.60	-4.2 Score on scale Standard Error 0.84	-4.3 Score on scale Standard Error 0.47	-4.4 Score on scale Standard Error 0.46

SECONDARY outcome

Timeframe: Baseline of Current Study (SHP621-302 [NCT02736409]), Week 12 and Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who had an evaluable current Study (SHP621-302 \[NCT02736409\]) baseline and assessment at specific category/time point.

Endoscopic findings with separate evaluations of the proximal and distal esophagus were recorded with respect to 5 categories: 1) exudates or plaques (grade 0-2); 2) fixed esophageal rings (grade 0-3); 3) edema (grade 0-2); 4) furrows (grade 0-2); and 5) strictures (grade 0-1). An endoscopy score for each category was calculated and summed for each anatomic location (proximal and distal). The minimum and maximum endoscopy score was 0 and 10 points respectively for each location (proximal and distal) and the total endoscopy score was the sum of the scores for the proximal and distal locations (maximum total score of 20 points respectively). The higher score indicated worse appearance. A negative change from baseline indicates that appearance improved.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Change From Current Study (SHP621-302 [NCT02736409]) Baseline in Total Endoscopy Score at Week 12 and Week 36 Week 12	0.7 Score on scale Standard Error 0.67	-1.0 Score on scale Standard Error 0.69	-0.3 Score on scale Standard Error 0.28	-2.6 Score on scale Standard Error 0.46
Change From Current Study (SHP621-302 [NCT02736409]) Baseline in Total Endoscopy Score at Week 12 and Week 36 Week 36	0.2 Score on scale Standard Error 0.70	0.0 Score on scale Standard Error 0.70	-0.6 Score on scale Standard Error 0.34	-2.3 Score on scale Standard Error 0.57

SECONDARY outcome

Timeframe: Baseline of induction study (SHP621-301 [NCT02605837]), Week 12 and Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who had an evaluable Induction Study (SHP621-301 \[NCT02605837\]) baseline and assessment at specific category/time point.

Change from induction study (SHP621-301 \[NCT02605837\]) baseline in peak eosinophil count at Week 12 and Week 36 of current study was reported.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Change From Induction Study (SHP621-301 [NCT02605837]) Baseline in Peak Eosinophil Count at Week 12 and Week 36 of Current Study Week 12	-20.8 eosinophil count Standard Error 13.41	-60.1 eosinophil count Standard Error 9.26	-33.2 eosinophil count Standard Error 5.14	-70.3 eosinophil count Standard Error 7.74
Change From Induction Study (SHP621-301 [NCT02605837]) Baseline in Peak Eosinophil Count at Week 12 and Week 36 of Current Study Week 36	-59.8 eosinophil count Standard Error 13.24	-40.3 eosinophil count Standard Error 13.23	-33.2 eosinophil count Standard Error 5.50	-57.2 eosinophil count Standard Error 7.68

SECONDARY outcome

Timeframe: Baseline of Current Study (SHP621-302 [NCT02736409]), Week 12 and Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who had an evaluable current Study (SHP621-302 \[NCT02736409\]) baseline and assessment at specific category/time point.

Change from current study (SHP621-302 \[NCT02736409\]) baseline in peak eosinophil count at Week 12 and Week 36 was reported.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Change From Current Study (SHP621-302 [NCT02736409]) Baseline in Peak Eosinophil Count at Week 12 and Week 36 Week 12	66.0 eosinophil count Standard Error 11.52	7.5 eosinophil count Standard Error 3.56	7.6 eosinophil count Standard Error 3.95	-54.4 eosinophil count Standard Error 5.65
Change From Current Study (SHP621-302 [NCT02736409]) Baseline in Peak Eosinophil Count at Week 12 and Week 36 Week 36	25.5 eosinophil count Standard Error 7.83	26.9 eosinophil count Standard Error 11.18	6.8 eosinophil count Standard Error 4.63	-39.1 eosinophil count Standard Error 6.94

SECONDARY outcome

Timeframe: Week 12 and Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure at specific category.

Proportion of participants who had Peak Eosinophil Count less than (\<) 15/HPF at Week 12 and Week 36 were reported.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Proportion of Participants Who Had Peak Eosinophil Count Less Than (<) 15/High-Powered Field (HPF) at Week 12 and Week 36 Week 12	0.13 proportion of participants	0.76 proportion of participants	0.37 proportion of participants	0.63 proportion of participants
Proportion of Participants Who Had Peak Eosinophil Count Less Than (<) 15/High-Powered Field (HPF) at Week 12 and Week 36 Week 36	0.52 proportion of participants	0.60 proportion of participants	0.29 proportion of participants	0.42 proportion of participants

SECONDARY outcome

Timeframe: Week 12 and Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study.

Proportion of participants who had Peak Eosinophil Count less than or equal to (\< or =) 1/High-Powered Field (HPF) at Week 12 and Week 36 were reported.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Proportion of Participants Who Had Peak Eosinophil Count Less Than or Equal to (< or =) 1/High-Powered Field (HPF) at Week 12 and Week 36 Week 12	0.00 proportion of participants	0.60 proportion of participants	0.15 proportion of participants	0.42 proportion of participants
Proportion of Participants Who Had Peak Eosinophil Count Less Than or Equal to (< or =) 1/High-Powered Field (HPF) at Week 12 and Week 36 Week 36	0.13 proportion of participants	0.44 proportion of participants	0.14 proportion of participants	0.26 proportion of participants

SECONDARY outcome

Timeframe: Baseline of induction study (SHP621-301 [NCT02605837]), Week 12 and Week 36

Population: FAS included all randomized participants who received at least one dose of a SHP621-302 (NCT02736409) investigational product. Here the number of participants analyzed signifies participants who had an evaluable Induction Study (SHP621-301 \[NCT02605837\]) baseline and assessment at specific category/time point.

Change from induction study (SHP621-301 \[NCT02605837\]) baseline in peak eosinophil count for each available esophageal level (proximal, mid, distal) at Week 12 and Week 36 of current study were reported.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Change From Induction Study (SHP621-301 [NCT02605837]) Baseline in Peak Eosinophil Count for Each Available Esophageal Level (Proximal, Mid, and Distal) at Week 12 and Week 36 of Current Study Proximal: Week 36	-21.0 eosinophil count Standard Error 7.09	-19.6 eosinophil count Standard Error 6.43	-24.2 eosinophil count Standard Error 4.44	-42.3 eosinophil count Standard Error 7.03
Change From Induction Study (SHP621-301 [NCT02605837]) Baseline in Peak Eosinophil Count for Each Available Esophageal Level (Proximal, Mid, and Distal) at Week 12 and Week 36 of Current Study Mid: Week 12	-14.8 eosinophil count Standard Error 10.80	-53.4 eosinophil count Standard Error 9.85	-32.7 eosinophil count Standard Error 4.80	-53.8 eosinophil count Standard Error 6.16
Change From Induction Study (SHP621-301 [NCT02605837]) Baseline in Peak Eosinophil Count for Each Available Esophageal Level (Proximal, Mid, and Distal) at Week 12 and Week 36 of Current Study Mid: Week 36	-36.8 eosinophil count Standard Error 9.89	-47.7 eosinophil count Standard Error 9.21	-29.1 eosinophil count Standard Error 5.05	-40.8 eosinophil count Standard Error 7.01
Change From Induction Study (SHP621-301 [NCT02605837]) Baseline in Peak Eosinophil Count for Each Available Esophageal Level (Proximal, Mid, and Distal) at Week 12 and Week 36 of Current Study Proximal: Week 12	-9.2 eosinophil count Standard Error 13.96	-23.3 eosinophil count Standard Error 4.94	-24.0 eosinophil count Standard Error 4.38	-41.6 eosinophil count Standard Error 6.65
Change From Induction Study (SHP621-301 [NCT02605837]) Baseline in Peak Eosinophil Count for Each Available Esophageal Level (Proximal, Mid, and Distal) at Week 12 and Week 36 of Current Study Distal: Week 12	-17.1 eosinophil count Standard Error 12.11	-44.0 eosinophil count Standard Error 6.74	-23.0 eosinophil count Standard Error 5.17	-53.6 eosinophil count Standard Error 6.64
Change From Induction Study (SHP621-301 [NCT02605837]) Baseline in Peak Eosinophil Count for Each Available Esophageal Level (Proximal, Mid, and Distal) at Week 12 and Week 36 of Current Study Distal: Week 36	-51.2 eosinophil count Standard Error 13.69	-25.3 eosinophil count Standard Error 12.45	-26.4 eosinophil count Standard Error 5.38	-40.2 eosinophil count Standard Error 7.71

SECONDARY outcome

Timeframe: Baseline of Current Study (SHP621-302 [NCT02736409]), Week 12 and Week 36

Population: FAS included all randomized participants who received at least one dose of a SHP621-302 (NCT02736409) investigational product. Here the number of participants analyzed signifies participants who had an evaluable current Study (SHP621-302 \[NCT02736409\]) baseline and assessment at specific category/time point.

Change from current study (SHP621-302 \[NCT02736409\]) baseline in peak eosinophil count for each available esophageal level (proximal, mid, distal) at Week 12 and Week 36 were reported.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Change From Current Study (SHP621-302 [NCT02736409]) Baseline in Peak Eosinophil Count for Each Available Esophageal Level (Proximal, Mid, and Distal) at Week 12 and Week 36 Proximal: Week 12	26.5 eosinophil count Standard Error 10.44	2.8 eosinophil count Standard Error 2.14	6.5 eosinophil count Standard Error 2.92	-30.8 eosinophil count Standard Error 4.73
Change From Current Study (SHP621-302 [NCT02736409]) Baseline in Peak Eosinophil Count for Each Available Esophageal Level (Proximal, Mid, and Distal) at Week 12 and Week 36 Proximal: Week 36	10.0 eosinophil count Standard Error 3.95	6.9 eosinophil count Standard Error 4.68	6.8 eosinophil count Standard Error 3.25	-23.1 eosinophil count Standard Error 4.91
Change From Current Study (SHP621-302 [NCT02736409]) Baseline in Peak Eosinophil Count for Each Available Esophageal Level (Proximal, Mid, and Distal) at Week 12 and Week 36 Mid: Week 12	38.4 eosinophil count Standard Error 10.50	5.4 eosinophil count Standard Error 2.88	3.2 eosinophil count Standard Error 4.20	-41.4 eosinophil count Standard Error 5.55
Change From Current Study (SHP621-302 [NCT02736409]) Baseline in Peak Eosinophil Count for Each Available Esophageal Level (Proximal, Mid, and Distal) at Week 12 and Week 36 Mid: Week 36	17.9 eosinophil count Standard Error 7.72	12.5 eosinophil count Standard Error 6.81	7.3 eosinophil count Standard Error 4.50	-28.9 eosinophil count Standard Error 7.00
Change From Current Study (SHP621-302 [NCT02736409]) Baseline in Peak Eosinophil Count for Each Available Esophageal Level (Proximal, Mid, and Distal) at Week 12 and Week 36 Distal: Week 12	55.8 eosinophil count Standard Error 10.04	7.3 eosinophil count Standard Error 3.51	7.8 eosinophil count Standard Error 3.66	-41.6 eosinophil count Standard Error 5.09
Change From Current Study (SHP621-302 [NCT02736409]) Baseline in Peak Eosinophil Count for Each Available Esophageal Level (Proximal, Mid, and Distal) at Week 12 and Week 36 Distal: Week 36	21.3 eosinophil count Standard Error 6.47	24.2 eosinophil count Standard Error 10.50	4.4 eosinophil count Standard Error 4.03	-29.5 eosinophil count Standard Error 6.20

SECONDARY outcome

Timeframe: Baseline of induction study (SHP621-301 [NCT02605837]), Week 12 and Week 36

Population: FAS included all randomized participants who received at least one dose of a SHP621-302 (NCT02736409) investigational product. Here the number of participants analyzed signifies participants who had an evaluable Induction Study (SHP621-301 \[NCT02605837\]) baseline and assessment at specific category/time point.

Eight histopathologic epithelial features (basal layer hyperplasia, eosinophil peak, abscesses, surface layering, dilated intercellular spaces, surface alteration, dyskeratotic epithelial cells, lamina propria fibrosis) are scored on a 4-point scale (0=normal, 3=worst) for both the severity of the abnormality (i.e., grade) and the amount of tissue affected by the abnormality (i.e. stage). Thus each of the 3 levels had a minimum score of 0 and maximum possible score of 24, and a possible total grade or stage score of 72 for a maximum combined score of 144. Combined total score ratio (TSR) =(proximal TSR + mid TSR + distal TSR)/N, where N is the number of non missing sections for TSR. A negative change from baseline indicates that epithelial inflammation decreased.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Change From Induction Study (SHP621-301 [NCT02605837]) Baseline in the Histopathologic Epithelial Features Combined Total Score (Grade and Stage) at Week 12 an Week 36 of Current Study Combined Grade TSR: Week 12	-0.1 score on scale Standard Error 0.04	-0.2 score on scale Standard Error 0.03	-0.2 score on scale Standard Error 0.02	-0.3 score on scale Standard Error 0.02
Change From Induction Study (SHP621-301 [NCT02605837]) Baseline in the Histopathologic Epithelial Features Combined Total Score (Grade and Stage) at Week 12 an Week 36 of Current Study Combined Grade TSR: Week 36	-0.2 score on scale Standard Error 0.03	-0.2 score on scale Standard Error 0.04	-0.1 score on scale Standard Error 0.02	-0.2 score on scale Standard Error 0.03
Change From Induction Study (SHP621-301 [NCT02605837]) Baseline in the Histopathologic Epithelial Features Combined Total Score (Grade and Stage) at Week 12 an Week 36 of Current Study Combined Stage TSR: Week 12	-0.1 score on scale Standard Error 0.04	-0.2 score on scale Standard Error 0.03	-0.2 score on scale Standard Error 0.02	-0.2 score on scale Standard Error 0.02
Change From Induction Study (SHP621-301 [NCT02605837]) Baseline in the Histopathologic Epithelial Features Combined Total Score (Grade and Stage) at Week 12 an Week 36 of Current Study Combined Stage TSR: Week 36	-0.2 score on scale Standard Error 0.03	-0.2 score on scale Standard Error 0.03	-0.1 score on scale Standard Error 0.02	-0.2 score on scale Standard Error 0.02

SECONDARY outcome

Timeframe: Baseline of Current Study (SHP621-302 [NCT02736409]), Week 12 and Week 36

Population: FAS included all randomized participants who received at least one dose of a SHP621-302 (NCT02736409) investigational product. Here the number of participants analyzed signifies participants who had an evaluable current Study (SHP621-302 \[NCT02736409\]) baseline and assessment at specific category/time point.

Eight histopathologic epithelial features (basal layer hyperplasia, eosinophil peak, abscesses, surface layering, dilated intercellular spaces, surface alteration, dyskeratotic epithelial cells, lamina propria fibrosis) are scored on a 4-point scale (0=normal, 3=worst) for both the severity of the abnormality (i.e., grade) and the amount of tissue affected by the abnormality (i.e. stage). Thus each of the 3 levels had a minimum score of 0 and maximum possible score of 24, and a possible total grade or stage score of 72 for a maximum combined score of 144. Combined total score ratio (TSR) =(proximal TSR + mid TSR + distal TSR)/N, where N is the number of non missing sections for TSR. A negative change from baseline indicates that epithelial inflammation decreased.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Change From Current Study (SHP621-302 [NCT02736409]) Baseline in the Histopathologic Epithelial Features Combined Total Score (Grade and Stage) at Week 12 and Week 36 Combined Grade TSR: Week 12	0.2 score on scale Standard Error 0.05	0.0 score on scale Standard Error 0.02	0.0 score on scale Standard Error 0.01	-0.2 score on scale Standard Error 0.02
Change From Current Study (SHP621-302 [NCT02736409]) Baseline in the Histopathologic Epithelial Features Combined Total Score (Grade and Stage) at Week 12 and Week 36 Combined Grade TSR: Week 36	0.1 score on scale Standard Error 0.03	0.1 score on scale Standard Error 0.03	0.0 score on scale Standard Error 0.02	-0.2 score on scale Standard Error 0.03
Change From Current Study (SHP621-302 [NCT02736409]) Baseline in the Histopathologic Epithelial Features Combined Total Score (Grade and Stage) at Week 12 and Week 36 Combined Stage TSR: Week 12	0.2 score on scale Standard Error 0.05	0.0 score on scale Standard Error 0.02	0.0 score on scale Standard Error 0.01	-0.2 score on scale Standard Error 0.02
Change From Current Study (SHP621-302 [NCT02736409]) Baseline in the Histopathologic Epithelial Features Combined Total Score (Grade and Stage) at Week 12 and Week 36 Combined Stage TSR: Week 36	0.1 score on scale Standard Error 0.03	0.1 score on scale Standard Error 0.03	0.0 score on scale Standard Error 0.02	-0.2 score on scale Standard Error 0.03

SECONDARY outcome

Timeframe: Week 12 and Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study.

Dysphagia symptom response from the baseline of SHP621-301, was defined as \>or=50% reduction in DSQ combined score (questions \[Q\] 2+3) from baseline of the induction study at Week 12 and 36 of current study. DSQ contained 4Q, all participants used diary, and responded to Q1(did you eat solid food) and Q2(didfood passslowly or get stuck). If participant's answer to Q2 was 'No', then diary ended for that day. If a participant answered 'Yes', he/she advanced to Q3(did you have to do anything to make food go down or get relief) and 4(extent to which participant experienced pain while swallowing). DSQ combined score= (\[sum of points from Q2+3 in daily DSQ\]×14)/ Number of diaries reported with non-missing data. Scale range was 0-2 for Q2 and 0-4 for Q3, with higher values representing a worse outcome. Scale range for DSQ combined score was 0-84, with higher values representing a worse outcome. Anegative change from baseline indicates that symptoms decreased.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Proportion of Participants Who Had Greater Than or Equal to (>or=) 50 Percent (%) Reduction in DSQ Combined Score From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 12 and Week 36 Week 12	0.52 proportion of participants	0.80 proportion of participants	0.41 proportion of participants	0.52 proportion of participants
Proportion of Participants Who Had Greater Than or Equal to (>or=) 50 Percent (%) Reduction in DSQ Combined Score From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 12 and Week 36 Week 36	0.74 proportion of participants	0.76 proportion of participants	0.41 proportion of participants	0.57 proportion of participants

SECONDARY outcome

Timeframe: Week 12 and Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study.

Dysphagia symptom response from the baseline of SHP621-302, was defined as \>or=50% reduction in DSQ combined score (questions 2+3) from baseline of the induction study at Week 36 of current study. DSQ contained 4Q, all participants used diary, and responded to Q1 (did you eat solid food) and Q2 (did food pass slowly or get stuck). If participant's answer to Q2 was 'No', then diary ended for that day. If a participant answered 'Yes', he/she advanced to Q3 (did you have to do anything to make food go down or get relief) and 4(extent to which participant experienced pain while swallowing). DSQ combined score= (\[sum of points from Q2+3 in daily DSQ\]×14)/ Number of diaries reported with non-missing data. Scale range was 0-2 for Q2 and 0-4 for Q3, with higher values representing a worse outcome. Scale range for DSQ combined score was 0-84, with higher values representing a worse outcome. A negative change from baseline indicates that symptoms decreased.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Proportion of Participants Who Had Greater Than or Equal to (>or=) 50 Percent (%) Reduction in DSQ Combined Score From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 12 and Week 36 Week 12	0.13 proportion of participants	0.36 proportion of participants	0.19 proportion of participants	0.37 proportion of participants
Proportion of Participants Who Had Greater Than or Equal to (>or=) 50 Percent (%) Reduction in DSQ Combined Score From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 12 and Week 36 Week 36	0.30 proportion of participants	0.36 proportion of participants	0.19 proportion of participants	0.38 proportion of participants

SECONDARY outcome

Timeframe: Baseline of induction study (SHP621-301 [NCT02605837]), Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.

DSQ contain 4 questions (Q), all participants used a diary, responded to Q1 (did you eat solid food), Q2 (did food pass slowly or get stuck). If participant's answer to Q2 was 'No', then diary ended for that day. If participant answered 'Yes', he/she advanced to Q3 (did you have to do anything to make food go down or get relief), Q4 (extent to which participant experienced pain while swallowing). DSQ combined score= (\[sum of points from Q2+3 in daily DSQ\] × 14)/Number of diaries reported with non-missing data. Scale range was 0-2 for Q2 and 0-4 for Q3. Scale range for DSQ combined score was 0-84. Higher values representing a worse outcome. A Negative change from baseline indicates symptoms decreased.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=20 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=22 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=73 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=51 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Change in the DSQ Combined Score (Questions 2+3) From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 36 of Current Study	-19.40 score on scale Standard Error 3.627	-23.28 score on scale Standard Error 2.477	-15.35 score on scale Standard Error 1.673	-17.33 score on scale Standard Error 2.269

SECONDARY outcome

Timeframe: Baseline of Current Study (SHP621-302 [NCT02736409]), Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.

DSQ contain 4 questions, all participants used a diary, responded to Q1 (did you eat solid food), Q2 (did food pass slowly or get stuck). If participant's answer to Q2 was 'No', then diary ended for that day. If participant answered 'Yes', he/she advanced to Q3 (did you have to do anything to make food go down or get relief), Q4 (extent to which participant experienced pain while swallowing). DSQ combined score= (\[sum of points from Q2+3 in daily DSQ\] × 14)/Number of diaries reported with non-missing data. Scale range was 0-2 for Q2 and 0-4 for Q3. Scale range for DSQ combined score was 0-84. Higher values representing a worse outcome. A Negative change from baseline indicates symptoms decreased. Change in DSQ combined score (Questions 2+3) from baseline of current study at Week 36 was reported.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=20 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=22 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=73 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=46 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Change in the DSQ Combined Score (Questions 2+3) From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 36	-4.00 score on scale Standard Error 1.928	-3.84 score on scale Standard Error 1.682	-4.39 score on scale Standard Error 1.356	-10.24 score on scale Standard Error 2.183

SECONDARY outcome

Timeframe: Baseline of induction study (SHP621-301 [NCT02605837]), Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.

Percent change in DSQ combined score from Induction Study (SHP621-301 \[NCT02605837\]) baseline to current study (SHP621-302 \[NCT02736409\]) final treatment period (Week 36) was reported.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=20 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=22 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=73 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=51 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Percent Change in the DSQ Combined Score (Questions 2+3) From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 36 of Current Study	-79.56 percent change Standard Error 7.370	-79.77 percent change Standard Error 6.195	-55.82 percent change Standard Error 5.048	-61.44 percent change Standard Error 8.653

SECONDARY outcome

Timeframe: Baseline of Current Study (SHP621-302 [NCT02736409]), Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants whose baseline DSQ combined score was not zero. Percent change cannot be calculated if baseline DSQ combined score is zero.

Percent change in DSQ combined score from baseline to final treatment period (Week 36) of current study was reported.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=14 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=16 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=56 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=39 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Percent Change in the DSQ Combined Score (Questions 2+3) From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 36	-47.00 percent change Standard Error 15.371	-40.78 percent change Standard Error 19.216	-10.18 percent change Standard Error 16.050	-39.04 percent change Standard Error 21.413

SECONDARY outcome

Timeframe: Week 12 and Week 36

Population: FAS included all randomized participants who received at least one dose of a SHP621-302 (NCT02736409) investigational product.

Overall binary response I was defined as if participant had peak eosinophil count of \<=6/HPF across all esophagus levels and achieved a minimum of 30% reduction in DSQ combined score from baseline of the induction study (SHP621-301 \[NCT02605837\]) at Week 12 and Week 36. DSQ combined score= (\[sum of points from questions 2+3 in the daily DSQ\]×14)/ Number of diaries reported with non-missing data. Scale range was 0 - 2 for question 2 and 0 - 4 for question 3, with higher values representing a worse outcome. Scale range for DSQ combined score was 0 - 84, with higher values representing a worse outcome. A negative change from baseline indicates that symptoms decreased.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Proportion of Participants Who Had Overall Binary Response I From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 12 and Week 36 of Current Study Week 12	0.04 proportion of participants	0.64 proportion of participants	0.15 proportion of participants	0.42 proportion of participants
Proportion of Participants Who Had Overall Binary Response I From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 12 and Week 36 of Current Study Week 36	0.26 proportion of participants	0.48 proportion of participants	0.13 proportion of participants	0.28 proportion of participants

SECONDARY outcome

Timeframe: Week 12 and Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study.

Overall binary response I was defined as if participant had peak eosinophil count of \<=6/HPF across all esophagus levels and achieved a minimum of 30% reduction in DSQ combined score from baseline at Week 12 and Week 36. DSQ combined score= (\[sum of points from questions 2+3 in the daily DSQ\]×14)/ Number of diaries reported with non-missing data. Scale range was 0 - 2 for question 2 and 0 - 4 for question 3, with higher values representing a worse outcome. Scale range for DSQ combined score was 0 - 84, with higher values representing a worse outcome. A negative change from baseline indicates that symptoms decreased.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Proportion of Participants Who Had Overall Binary Response I From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 12 and Week 36 Week 12	0.00 proportion of participants	0.32 proportion of participants	0.05 proportion of participants	0.29 proportion of participants
Proportion of Participants Who Had Overall Binary Response I From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 12 and Week 36 Week 36	0.09 proportion of participants	0.20 proportion of participants	0.06 proportion of participants	0.17 proportion of participants

SECONDARY outcome

Timeframe: Week 12 and Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study.

Overall binary response II was defined as if participant had peak eosinophil count of \<=6/HPF across all esophagus levels and achieved a minimum of 50% reduction in DSQ combined score from baseline of the SHP621-301 study at Week 12 and Week 36. DSQ combined score= (\[sum of points from questions 2+3 in the daily DSQ\]×14)/ Number of diaries reported with non-missing data. Scale range was 0 - 2 for question 2 and 0 - 4 for question 3, with higher values representing a worse outcome. Scale range for DSQ combined score was 0 - 84, with higher values representing a worse outcome. A negative change from baseline indicates that symptoms decreased.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Proportion of Participants Who Had Overall Binary Response II From Induction Study SHP621-301 (NCT02605837) Baseline at Week 12 and Week 36 of Current Study Week 12	0.04 proportion of participants	0.64 proportion of participants	0.12 proportion of participants	0.38 proportion of participants
Proportion of Participants Who Had Overall Binary Response II From Induction Study SHP621-301 (NCT02605837) Baseline at Week 12 and Week 36 of Current Study Week 36	0.26 proportion of participants	0.44 proportion of participants	0.12 proportion of participants	0.28 proportion of participants

SECONDARY outcome

Timeframe: Week 12 and Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study.

Overall binary response II was defined as if participant had peak eosinophil count of \<=6/HPF across all esophagus levels and achieved a minimum of 30% reduction in DSQ combined score from baseline at Week 12 and Week 36. DSQ combined score= (\[sum of points from questions 2+3 in the daily DSQ\]×14)/ Number of diaries reported with non-missing data. Scale range was 0 - 2 for question 2 and 0 - 4 for question 3, with higher values representing a worse outcome. Scale range for DSQ combined score was 0 - 84, with higher values representing a worse outcome. A negative change from baseline indicates that symptoms decreased.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Proportion of Participants Who Had Overall Binary Response II From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 12 and Week 36 Week 12	0.00 proportion of participants	0.28 proportion of participants	0.04 proportion of participants	0.26 proportion of participants
Proportion of Participants Who Had Overall Binary Response II From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 12 and Week 36 Week 36	0.04 proportion of participants	0.20 proportion of participants	0.06 proportion of participants	0.17 proportion of participants

SECONDARY outcome

Timeframe: Baseline of induction study (SHP621-301 [NCT02605837]), Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.

DSQ contained 4 questions, all participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). DSQ + pain score was calculated by summing the scores of responses to questions 2, 3, and 4 by using following formula: DSQ + pain score= (\[sum of points from questions 2+3+4 in the daily DSQ\] ×14)/ Number of diaries reported with non-missing data. Scale range was 0 - 2 for question 2, 0 - 4 for question 3 and 0 - 4 for question 4, with higher values representing a worse outcome. Scale range for DSQ + pain score was 0 - 140, with higher values representing a worse outcome. A negative change from baseline indicates that symptoms decreased.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=20 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=22 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=73 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=51 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Change in the DSQ + Pain Score (Questions 2+3+4) From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 36 of Current Study	-25.86 score on scale Standard Error 5.023	-31.10 score on scale Standard Error 4.015	-21.25 score on scale Standard Error 2.299	-23.17 score on scale Standard Error 3.221

SECONDARY outcome

Timeframe: Baseline of Current Study (SHP621-302 [NCT02736409]), Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.

DSQ contained 4 questions, all participants used a diary, and responded to Questions (Q) 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Q2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Q3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). DSQ + pain score was calculated by summing the scores of responses to Questions 2, 3, and 4. Question 1 was excluded from the DSQ + pain score. DSQ + pain score=(Sum of points from questions 2+3+4 in the daily DSQ)\*14 Days/Number of dairies reported with non-missing data. Scale range was 0 - 2 for Q2, 0 - 4 for Q3 and 0 - 4 for Q4, with higher values representing a worse outcome. Scale range for DSQ + pain score was 0 - 140, with higher values representing a worse outcome. A negative change from baseline indicates that symptoms decreased.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=20 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=22 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=73 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=46 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Change in the DSQ+ Pain Score (Questions 2+3+4) From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 36	-5.67 score on scale Standard Error 2.704	-4.23 score on scale Standard Error 2.003	-5.59 score on scale Standard Error 1.825	-14.12 score on scale Standard Error 2.944

SECONDARY outcome

Timeframe: Baseline of induction study (SHP621-301 [NCT02605837]), Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.

DSQ contained 4 questions, all participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). DSQ pain score was calculated by summing the scores of responses to Question 4 only. DSQ pain score=(sum of points from questions 4 in the daily DSQ)\*14 days/Number of diaries reported with non-missing data. Scale range was 0 - 4 for question 4, with higher values representing a worse outcome. Scale range for DSQ pain score was 0 - 56, with higher values representing a worse outcome. A negative change from baseline indicates that symptoms decreased.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=20 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=22 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=73 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=51 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Change in the DSQ Pain Score (Question 4) From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 36 of Current Study	-6.46 score on scale Standard Error 1.667	-7.92 score on scale Standard Error 2.130	-5.90 score on scale Standard Error 0.907	-5.83 score on scale Standard Error 1.356

SECONDARY outcome

Timeframe: Baseline of Current Study (SHP621-302 [NCT02736409]), Week 36

Population: FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.

DSQ contained 4 questions, all participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). DSQ pain score was calculated by summing the scores of responses to Question 4 only. DSQ pain score=(sum of points from questions 4 in the daily DSQ)\*14 days/Number of diaries reported with non-missing data. Scale range was 0 - 4 for question 4, with higher values representing a worse outcome. Scale range for DSQ pain score was 0 - 56, with higher values representing a worse outcome. A negative change from baseline indicates that symptoms decreased.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=20 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=22 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=73 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=46 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Change in the DSQ Pain Score (Question 4) From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 36	-1.67 score on scale Standard Error 1.039	-0.39 score on scale Standard Error 0.495	-1.20 score on scale Standard Error 0.634	-3.88 score on scale Standard Error 1.101

SECONDARY outcome

Timeframe: From start of the study drug administration up to follow up (Week 40)

Population: Safety Set consisted of all participants who received at least 1 dose of investigational product.

An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs that started or deteriorated on or after the date of the first dose of double-blind IP in SHP621-302 and through the safety follow-up contact, or 31 days after the last dose of IP for participants who did not have a safety follow-up contact.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Number of Participants With Treatment Emergent Adverse Events (TEAE's)	14 Participants	21 Participants	72 Participants	49 Participants

SECONDARY outcome

Timeframe: Baseline of induction study (SHP621-301 [NCT02605837]), Week 36

Population: Safety set consisted of all participants who received at least 1 dose of investigational product. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.

The sites for DXA measurement were the lumber spine (L1-L4 preferred) and total body less head. DXA scans for bone mineral density (BMD) and body composition measurements were done only for adolescent participants aged 11-17 years based on the age group in the SHP621-301 study and were completed throughout the SHP621-302 study even if participants turned 18 years. Baseline of SHP621-301 is determined at Week 0 in the SHP621-301 study. Here in this outcome measure DXA measurement of L1-L4 were reported. Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=2 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=12 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=8 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Change in DXA (Dual-Energy X-ray Absorptiometry) Imaging Results (Location: Lumbar Spine [L1-L4]) From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 36 of Current Study	—	-0.185 Z score Standard Deviation 0.2475	0.020 Z score Standard Deviation 0.3637	0.100 Z score Standard Deviation 0.4247

SECONDARY outcome

Timeframe: Baseline of Current Study (SHP621-302 [NCT02736409]), Week 36

Population: Safety set consisted of all participants who received at least 1 dose of investigational product. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.

The sites for DXA measurement were the lumber spine (L1-L4 preferred) and total body less head. DXA scans for bone mineral density (BMD) and body composition measurements were done only for adolescent participants aged 11-17 years based on the age group in the SHP621-301 study and were completed throughout the SHP621-302 study even if participants turned 18 years. Here in this outcome measure DXA measurement of L1-L4 were reported. Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=2 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=12 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=8 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Change in DXA Imaging Results (Location: Lumbar Spine [L1-L4]) From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 36	—	-0.240 Z score Standard Deviation 0.7495	0.062 Z score Standard Deviation 0.4839	0.071 Z score Standard Deviation 0.4783

SECONDARY outcome

Timeframe: Baseline of induction study (SHP621-301 [NCT02605837]), Week 36

Population: Safety set consisted of all participants who received at least 1 dose of investigational product. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.

The sites for DXA measurement were the lumber spine (L1-L4 preferred) and total body less head. DXA scans for bone mineral density (BMD) and body composition measurements were done only for adolescent participants aged 11-17 years based on the age group in the SHP621-301 study and were completed throughout the SHP621-302 study even if participants turned 18 years. Baseline of SHP621-301 is determined at Week 0 in the SHP621-301 study. Here in this outcome measure DXA measurement of whole body (except head) were reported. Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=2 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=12 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=8 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Change in DXA Imaging Results (Location: Whole Body) From Baseline of Induction Study (SHP621-301 [NCT02605837]) at Week 36 of Current Study	—	0.190 Z score Standard Deviation 0.0424	-0.023 Z score Standard Deviation 0.4510	0.244 Z score Standard Deviation 0.5543

SECONDARY outcome

Timeframe: Baseline of Current Study (SHP621-302 [NCT02736409]), Week 36

Population: Safety set consisted of all participants who received at least 1 dose of investigational product. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.

The sites for DXA measurement were the lumber spine (L1-L4 preferred) and total body less head. DXA scans for bone mineral density (BMD) and body composition measurements were done only for adolescent participants aged 11-17 years based on the age group in the SHP621-301 study and were completed throughout the SHP621-302 study even if participants turned 18 years. Here in this outcome measure DXA measurement of whole body (except head) were reported. Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=2 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=12 Participants Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=8 Participants PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Change in DXA Imaging Results (Location: Whole Body) From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 36	—	0.065 Z score Standard Deviation 0.0636	-0.070 Z score Standard Deviation 0.4060	0.140 Z score Standard Deviation 0.4173

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12 and Week 36

Population: SHP621-301 (NCT02605837) BOS Full Responder FAS consisted of all randomized participants who were determined to be Full responders to the BOS treatment during the induction study SHP621-301 (NCT02605837) and who received at least 1 dose of IP in the SHP621-302 (NCT02736409) study.

Eosinophil histology relapse was defined as an eosinophil count of \>or=15 eos/HPF from at least 2 of 3 levels of the esophagus.

Outcome measures

Outcome measures
Measure	Full Responder BOS-PBO Group n=23 Participants Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 Participants Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Proportion of Participants Who Had a Histologic Response (Eosinophil Count of Greater Than or Equal to (>or=15)/High-Powered Field [HPF]) Before or at Week 12 and Before or at Week 36 Histologic Relapse before or at Week 12	0.65 proportion of participants	0.12 proportion of participants	—	—
Proportion of Participants Who Had a Histologic Response (Eosinophil Count of Greater Than or Equal to (>or=15)/High-Powered Field [HPF]) Before or at Week 12 and Before or at Week 36 Histologic Relapse before or at Week 36	0.78 proportion of participants	0.36 proportion of participants	—	—

Adverse Events

Full Responder BOS-PBO Group

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Full Responder BOS-BOS Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Non-Responder BOS-BOS Group

Serious events: 6 serious events

Other events: 26 other events

Deaths: 0 deaths

PBO-BOS Group

Serious events: 5 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Full Responder BOS-PBO Group n=23 participants at risk Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 participants at risk Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 participants at risk Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 participants at risk PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Musculoskeletal and connective tissue disorders Back pain	4.3% 1/23 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/25 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/106 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/65 • From start of the study drug administration up to follow up (Week 40)
General disorders Non-cardiac chest pain	0.00% 0/23 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/25 • From start of the study drug administration up to follow up (Week 40)	0.94% 1/106 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/65 • From start of the study drug administration up to follow up (Week 40)
Immune system disorders Anaphylactic reaction	0.00% 0/23 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/25 • From start of the study drug administration up to follow up (Week 40)	0.94% 1/106 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)	3.1% 2/65 • Number of events 2 • From start of the study drug administration up to follow up (Week 40)
Immune system disorders Anaphylactic shock	0.00% 0/23 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/25 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/106 • From start of the study drug administration up to follow up (Week 40)	1.5% 1/65 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)
Infections and infestations Appendicitis	0.00% 0/23 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/25 • From start of the study drug administration up to follow up (Week 40)	0.94% 1/106 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/65 • From start of the study drug administration up to follow up (Week 40)
Infections and infestations Herpes simplex	0.00% 0/23 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/25 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/106 • From start of the study drug administration up to follow up (Week 40)	1.5% 1/65 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)
Injury, poisoning and procedural complications Head injury	0.00% 0/23 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/25 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/106 • From start of the study drug administration up to follow up (Week 40)	1.5% 1/65 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/23 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/25 • From start of the study drug administration up to follow up (Week 40)	0.94% 1/106 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/65 • From start of the study drug administration up to follow up (Week 40)
Injury, poisoning and procedural complications Neck injury	0.00% 0/23 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/25 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/106 • From start of the study drug administration up to follow up (Week 40)	1.5% 1/65 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/23 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/25 • From start of the study drug administration up to follow up (Week 40)	0.94% 1/106 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/65 • From start of the study drug administration up to follow up (Week 40)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/23 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/25 • From start of the study drug administration up to follow up (Week 40)	0.94% 1/106 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/65 • From start of the study drug administration up to follow up (Week 40)

Other adverse events

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Publication restrictions are in place

Restriction type: OTHER

Measure	Full Responder BOS-PBO Group n=23 participants at risk Full responder BOS (Budesonide Oral Suspension)-PBO (Placebo) group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to double-blind placebo twice daily. Participants received 10 milliliter (mL) of 0.2 milligram per milliliter (mg/mL) placebo orally twice daily for 36 weeks.	Full Responder BOS-BOS Group n=25 participants at risk Full responder BOS-BOS group consisted of participants who were full responders at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who were randomized to remain on double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	Non-Responder BOS-BOS Group n=106 participants at risk Non-responder BOS-BOS group consisted of participants who were not full responders (ie, partial or non-responders) at the end of 12 weeks double-blind treatment with BOS in SHP621-301 (NCT02605837) and who continued to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.	PBO-BOS Group n=65 participants at risk PBO-BOS group consisted of participants who received placebo in SHP621-301 (NCT02605837) and were assigned to receive double-blind BOS 2 mg twice daily. Participants received 10 mL of 0.2 mg/mL BOS twice daily for 36 weeks.
Gastrointestinal disorders Diarrhoea	4.3% 1/23 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)	12.0% 3/25 • Number of events 3 • From start of the study drug administration up to follow up (Week 40)	1.9% 2/106 • Number of events 2 • From start of the study drug administration up to follow up (Week 40)	6.2% 4/65 • Number of events 5 • From start of the study drug administration up to follow up (Week 40)
Gastrointestinal disorders Dysphagia	8.7% 2/23 • Number of events 2 • From start of the study drug administration up to follow up (Week 40)	4.0% 1/25 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)	1.9% 2/106 • Number of events 2 • From start of the study drug administration up to follow up (Week 40)	1.5% 1/65 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)
Gastrointestinal disorders Gastritis	0.00% 0/23 • From start of the study drug administration up to follow up (Week 40)	16.0% 4/25 • Number of events 4 • From start of the study drug administration up to follow up (Week 40)	1.9% 2/106 • Number of events 2 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/65 • From start of the study drug administration up to follow up (Week 40)
Gastrointestinal disorders Nausea	8.7% 2/23 • Number of events 2 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/25 • From start of the study drug administration up to follow up (Week 40)	8.5% 9/106 • Number of events 11 • From start of the study drug administration up to follow up (Week 40)	6.2% 4/65 • Number of events 5 • From start of the study drug administration up to follow up (Week 40)
Gastrointestinal disorders Vomiting	0.00% 0/23 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/25 • From start of the study drug administration up to follow up (Week 40)	12.3% 13/106 • Number of events 18 • From start of the study drug administration up to follow up (Week 40)	1.5% 1/65 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)
General disorders Fatigue	8.7% 2/23 • Number of events 4 • From start of the study drug administration up to follow up (Week 40)	8.0% 2/25 • Number of events 3 • From start of the study drug administration up to follow up (Week 40)	1.9% 2/106 • Number of events 2 • From start of the study drug administration up to follow up (Week 40)	1.5% 1/65 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)
Immune system disorders Seasonal allergy	8.7% 2/23 • Number of events 2 • From start of the study drug administration up to follow up (Week 40)	4.0% 1/25 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)	0.94% 1/106 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/65 • From start of the study drug administration up to follow up (Week 40)
Infections and infestations Nasopharyngitis	13.0% 3/23 • Number of events 3 • From start of the study drug administration up to follow up (Week 40)	4.0% 1/25 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)	5.7% 6/106 • Number of events 7 • From start of the study drug administration up to follow up (Week 40)	4.6% 3/65 • Number of events 3 • From start of the study drug administration up to follow up (Week 40)
Infections and infestations Oesophageal candidiasis	0.00% 0/23 • From start of the study drug administration up to follow up (Week 40)	4.0% 1/25 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)	2.8% 3/106 • Number of events 3 • From start of the study drug administration up to follow up (Week 40)	7.7% 5/65 • Number of events 5 • From start of the study drug administration up to follow up (Week 40)
Infections and infestations Oropharyngeal candidiasis	0.00% 0/23 • From start of the study drug administration up to follow up (Week 40)	8.0% 2/25 • Number of events 2 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/106 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/65 • From start of the study drug administration up to follow up (Week 40)
Infections and infestations Sinusitis	8.7% 2/23 • Number of events 2 • From start of the study drug administration up to follow up (Week 40)	4.0% 1/25 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)	3.8% 4/106 • Number of events 5 • From start of the study drug administration up to follow up (Week 40)	4.6% 3/65 • Number of events 3 • From start of the study drug administration up to follow up (Week 40)
Infections and infestations Upper respiratory tract infection	4.3% 1/23 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)	12.0% 3/25 • Number of events 4 • From start of the study drug administration up to follow up (Week 40)	8.5% 9/106 • Number of events 9 • From start of the study drug administration up to follow up (Week 40)	3.1% 2/65 • Number of events 2 • From start of the study drug administration up to follow up (Week 40)
Infections and infestations Urinary tract infection	0.00% 0/23 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/25 • From start of the study drug administration up to follow up (Week 40)	0.94% 1/106 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)	6.2% 4/65 • Number of events 4 • From start of the study drug administration up to follow up (Week 40)
Investigations Blood cortisol decreased	0.00% 0/23 • From start of the study drug administration up to follow up (Week 40)	4.0% 1/25 • Number of events 1 • From start of the study drug administration up to follow up (Week 40)	2.8% 3/106 • Number of events 3 • From start of the study drug administration up to follow up (Week 40)	6.2% 4/65 • Number of events 5 • From start of the study drug administration up to follow up (Week 40)
Psychiatric disorders Mood swings	8.7% 2/23 • Number of events 2 • From start of the study drug administration up to follow up (Week 40)	0.00% 0/25 • From start of the study drug administration up to follow up (Week 40)	1.9% 2/106 • Number of events 2 • From start of the study drug administration up to follow up (Week 40)	4.6% 3/65 • Number of events 4 • From start of the study drug administration up to follow up (Week 40)