Trial Outcomes & Findings for Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis (NCT NCT01008410)

NCT ID: NCT01008410

Last Updated: 2019-08-14

Results Overview

Remission was a combined assessment of clinical and endoscopic variables, defined as an endoscopy score of less than or equal to (\<=) 1, a rectal bleeding score of 0, and an improvement or no change from baseline in stool frequency subscales of the Modified Mayo Disease Activity Index (MMDAI) at the end of 6 weeks of treatment. MMDAI was used to assess the overall disease activity for each participant. MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment (PGA) and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Stool frequency MMDAI subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Endoscopy MMDAI subscore ranged from 0-3, where 0 indicated normal or inactive disease and 3 indicated severe disease (spontaneous bleeding, ulceration).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 265 participants
• Primary outcome timeframe: Week 6
• Results posted on: 2019-08-14

Participant Flow

Participant milestones

Measure	Budesonide Participants who were diagnosed with active mild to moderate ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS), received 2 milligrams (mg)/25 milliliter (mL) of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.	Placebo Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
Overall Study STARTED	133	132
Overall Study Received at Least 1 Dose of Study Drug	133	132
Overall Study COMPLETED	108	116
Overall Study NOT COMPLETED	25	16

Reasons for withdrawal

Measure	Budesonide Participants who were diagnosed with active mild to moderate ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS), received 2 milligrams (mg)/25 milliliter (mL) of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.	Placebo Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
Overall Study Adverse Event	13	7
Overall Study Withdrawal by Subject	6	2
Overall Study Lost to Follow-up	1	0
Overall Study Noncompliance	1	0
Overall Study Low Cortisol	2	0
Overall Study Lack of Efficacy	2	6
Overall Study Met Exclusion Criterion	0	1

Baseline Characteristics

Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

Baseline characteristics by cohort

Measure	Budesonide n=133 Participants Participants who were diagnosed with active mild to moderate (UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.	Placebo n=132 Participants Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.	Total n=265 Participants Total of all reporting groups
Age, Continuous	43.2 years STANDARD_DEVIATION 13.94 • n=5 Participants	41.4 years STANDARD_DEVIATION 13.24 • n=7 Participants	42.4 years STANDARD_DEVIATION 13.60 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	80 Participants n=7 Participants	152 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	52 Participants n=7 Participants	113 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	113 Participants n=5 Participants	110 Participants n=7 Participants	223 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	5 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	115 Participants n=5 Participants	123 Participants n=7 Participants	238 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 6

Population: ITT population included all randomized participants. Missing data was imputed using last observation carried forward (LOCF) method.

Remission was a combined assessment of clinical and endoscopic variables, defined as an endoscopy score of less than or equal to (<=) 1, a rectal bleeding score of 0, and an improvement or no change from baseline in stool frequency subscales of the Modified Mayo Disease Activity Index (MMDAI) at the end of 6 weeks of treatment. MMDAI was used to assess the overall disease activity for each participant. MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment (PGA) and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Stool frequency MMDAI subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Endoscopy MMDAI subscore ranged from 0-3, where 0 indicated normal or inactive disease and 3 indicated severe disease (spontaneous bleeding, ulceration).

Outcome measures

Measure	Budesonide n=133 Participants Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.	Placebo n=132 Participants Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
Percentage of Participants Who Achieved Remission	38.3 percentage of participants	25.8 percentage of participants

SECONDARY outcome

Timeframe: Week 6

Population: ITT population included all randomized participants.

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices:stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Missing data was imputed using LOCF method.

Outcome measures

Measure	Budesonide n=133 Participants Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.	Placebo n=132 Participants Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6	46.6 percentage of participants	28.0 percentage of participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, and 6

Population: ITT population included all randomized participants.

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Percentage of participants who were rectal bleeding responder at scheduled assessments were reported. Rectal bleeding responders were defined as those participants who achieved a rectal bleeding MMDAI subscale score of 0 during the treatment period. Missing data was imputed using LOCF method.

Outcome measures

Measure	Budesonide n=133 Participants Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.	Placebo n=132 Participants Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
Number of Scheduled Assessments With Rectal Bleeding Responder Classification Responder at 1 Assessment	12.0 percentage of participants	13.6 percentage of participants
Number of Scheduled Assessments With Rectal Bleeding Responder Classification Responder at 2 Assessment	18.8 percentage of participants	13.6 percentage of participants
Number of Scheduled Assessments With Rectal Bleeding Responder Classification Responder at 3 Assessment	21.1 percentage of participants	10.6 percentage of participants
Number of Scheduled Assessments With Rectal Bleeding Responder Classification Responder at 4 Assessment	6.0 percentage of participants	1.5 percentage of participants

SECONDARY outcome

Timeframe: Week 6

Population: ITT population included all randomized participants.

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Endoscopy subscale ranged from 0-3, where 0 = normal or inactive disease, 1 = mild disease, 2 = moderate disease and 3 = severe disease (spontaneous bleeding, ulceration). Percentage of participants with normal or mild disease have been presented in this outcome measure. Missing data was imputed using LOCF method.

Outcome measures

Measure	Budesonide n=133 Participants Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.	Placebo n=132 Participants Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
Percentage of Participants Who Achieved an Endoscopy MMDAI Subscale Score of 0 or 1 at End of Week 6	55.6 percentage of participants	43.2 percentage of participants

SECONDARY outcome

Timeframe: Week 6

Population: ITT population included all randomized participants.

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Bowel frequency (BF) subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal disease and 3 indicated severe disease. Missing data was imputed using LOCF method.

Outcome measures

Measure	Budesonide n=133 Participants Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.	Placebo n=132 Participants Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
Percentage of Participants Who Achieved a Score of 0 for Rectal Bleeding Subscale and a Combined Score of <=2 for Bowel Frequency and Physician's Global Assessment (PGA) in the MMDAI Subscales at End of Week 6	41.4 percentage of participants	25.8 percentage of participants

SECONDARY outcome

Timeframe: Week 6

Population: ITT population included all randomized participants.

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. Physician global assessment (PGA) subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method.

Outcome measures

Measure	Budesonide n=133 Participants Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.	Placebo n=132 Participants Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
Percentage of Participants Who Achieved an MMDAI Total Score of <= 3 With Greater Than or Equal to (>=2) Points of Improvement From Baseline at the End of Week 6	45.9 percentage of participants	30.3 percentage of participants

SECONDARY outcome

Timeframe: Week 6

Population: ITT population included all randomized participants.

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Endoscopy subscore ranged from 0-3, where 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern), 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 = severe disease (spontaneous bleeding, ulceration). Missing data was imputed using LOCF method.

Outcome measures

Measure	Budesonide n=133 Participants Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.	Placebo n=132 Participants Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Endoscopy Subscale Score at End of Week 6	57.1 percentage of participants	47.7 percentage of participants

SECONDARY outcome

Timeframe: Week 6

Population: ITT population included all randomized participants.

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, and 3 indicated blood alone passed. Missing data was imputed using LOCF method.

Outcome measures

Measure	Budesonide n=133 Participants Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.	Placebo n=132 Participants Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score at End of Week 6	70.7 percentage of participants	53.0 percentage of participants

SECONDARY outcome

Timeframe: Week 6

Population: ITT population included all randomized participants.

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method.

Outcome measures

Measure	Budesonide n=133 Participants Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.	Placebo n=132 Participants Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
Percentage of Participants Who Achieved >=3 Point Improvement From Baseline in the MMDAI Total Score Including Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score and MMDAI Endoscopy Subscale at End of Week 6	52.6 percentage of participants	37.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: ITT population included all randomized participants.

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method.

Outcome measures

Measure	Budesonide n=133 Participants Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.	Placebo n=132 Participants Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores Bowel frequency score: Baseline	1.8 unit on a scale Standard Deviation 0.87	1.9 unit on a scale Standard Deviation 0.93
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores Bowel frequency score: Change at Week 6	-0.7 unit on a scale Standard Deviation 0.98	-0.5 unit on a scale Standard Deviation 0.85
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores Rectal Bleeding score:Baseline	2.1 unit on a scale Standard Deviation 0.38	2.1 unit on a scale Standard Deviation 0.36
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores Rectal Bleeding score: Change at Week 6	-1.2 unit on a scale Standard Deviation 0.95	-0.8 unit on a scale Standard Deviation 0.93
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores PGA score:Baseline	1.8 unit on a scale Standard Deviation 0.43	1.8 unit on a scale Standard Deviation 0.41
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores PGA score: Change at Week 6	-0.8 unit on a scale Standard Deviation 0.79	-0.5 unit on a scale Standard Deviation 0.78
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores Endoscopy score:Baseline	2.1 unit on a scale Standard Deviation 0.30	2.1 unit on a scale Standard Deviation 0.29
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores Endoscopy score: Change at Week 6	-0.8 unit on a scale Standard Deviation 0.76	-0.5 unit on a scale Standard Deviation 0.74
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores Total score:Baseline	7.8 unit on a scale Standard Deviation 1.23	7.9 unit on a scale Standard Deviation 1.28
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores Total score: Change at Week 6	-3.5 unit on a scale Standard Deviation 2.80	-2.4 unit on a scale Standard Deviation 2.74

Adverse Events

Budesonide

Serious events: 2 serious events

Other events: 66 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Measure	Budesonide n=134 participants at risk Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.	Placebo n=131 participants at risk Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Immune system disorders Hypersensitivity	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 0/72 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	1.2% 1/80 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Vascular disorders Arterial thrombosis limb	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.

Other adverse events

Measure	Budesonide n=134 participants at risk Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.	Placebo n=131 participants at risk Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
Musculoskeletal and connective tissue disorders Back pain	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Infections and infestations Herpes zoster	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Haemorrhoids	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	1.5% 2/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Proctitis ulcerative	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	3.1% 4/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Investigations Blood bilirubin increased	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	1.5% 2/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Tongue geographic	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Nervous system disorders Syncope	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Flatulence	1.5% 2/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Abdominal pain	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	1.5% 2/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Infections and infestations Upper respiratory tract infection	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	2.3% 3/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Infections and infestations Acute sinusitis	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Infections and infestations Vulvovaginal mycotic infection	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Injury, poisoning and procedural complications Concussion	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Anorectal discomfort	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Nervous system disorders Dizziness	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	1.5% 2/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Colitis ulcerative	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	1.5% 2/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
General disorders Oedema peripheral	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	1.5% 2/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Infections and infestations Urinary tract infection	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	1.5% 2/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Reproductive system and breast disorders Nipple pain	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Infections and infestations Pharyngitis streptococcal	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Infections and infestations Pharyngitis	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Constipation	1.5% 2/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	1.5% 2/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	1.5% 2/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Abdominal tenderness	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	1.5% 2/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Proctalgia	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Abdominal pain upper	3.0% 4/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Nausea	3.0% 4/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Gastrointestinal sounds abnormal	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Mouth ulceration	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Abdominal discomfort	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Rectal prolapse	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Vomiting	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Dry mouth	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Anal pruritus	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Infections and infestations Bronchitis	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Infections and infestations Nasopharyngitis	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Infections and infestations Gastroenteritis viral	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Infections and infestations Acute tonsillitis	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Infections and infestations Viral upper respiratory tract infection	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Infections and infestations Influenza	1.5% 2/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Blood and lymphatic system disorders Anaemia	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Blood and lymphatic system disorders Iron deficiency anaemia	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	2.3% 3/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Musculoskeletal and connective tissue disorders Myalgia	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Musculoskeletal and connective tissue disorders Pain in extremity	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Musculoskeletal and connective tissue disorders Muscle tightness	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Sinus congestion	1.5% 2/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Cough	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Nervous system disorders Lethargy	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Nervous system disorders Paraesthesia	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Nervous system disorders Sciatica	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
General disorders Non-cardiac chest pain	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
General disorders Fatigue	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
General disorders Application site pain	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Vascular disorders Hypotension	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Infections and infestations Cellulitis	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Eye disorders Eye swelling	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Eye disorders Conjunctivitis	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Investigations Alanine aminotransferase increased	1.5% 2/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Investigations Aspartate aminotransferase increased	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Investigations Blood alkaline phosphatase increased	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Investigations Blood potassium increased	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Investigations Blood cortisol decreased	18.7% 25/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Investigations Blood glucose abnormal	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Investigations ACTH stimulation test abnormal	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Endocrine disorders Adrenal insufficiency	5.2% 7/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	1.5% 2/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Skin and subcutaneous tissue disorders Ingrown hair	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Skin and subcutaneous tissue disorders Rash	1.5% 2/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Skin and subcutaneous tissue disorders Purpura senile	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Metabolism and nutrition disorders Hypercalcaemia	1.5% 2/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Metabolism and nutrition disorders Hyperglycaemia	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Metabolism and nutrition disorders Hypochloraemia	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Metabolism and nutrition disorders Hyponatraemia	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Hepatobiliary disorders Hyperbilirubinaemia	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	1.5% 2/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Nervous system disorders Headache	3.0% 4/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.76% 1/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Injury, poisoning and procedural complications Ligament rupture	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Injury, poisoning and procedural complications Limb injury	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Psychiatric disorders Depression	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Psychiatric disorders Sleep disorder	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Psychiatric disorders Insomnia	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Reproductive system and breast disorders Vaginal haemorrhage	1.4% 1/72 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/80 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Reproductive system and breast disorders Sexual dysfunction	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.
Gastrointestinal disorders Diarrhoea	0.75% 1/134 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.	0.00% 0/131 • From start of study drug up to Week 8 Safety population included all randomized participants who were administered at least one dose of the study drug. 1 participant was randomized to placebo, but received both placebo and budesonide during study. This participant was analyzed in placebo group in all efficacy analyses and is summarized in budesonide group in all safety analyses.

Additional Information

Director of Clinical Operations

Bausch Health Companies

Email: Lindsey.Mathew@bauschhealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
• Publication restrictions are in place

Restriction type: OTHER