Efficacy and Safety of Budesonide Foam for Participants W... | NCT01008410

NCT01008410

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Budesonide	Experimental	Participants who were diagnosed with active mild to moderate UP or UPS, will receive 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.	Drug: Budesonide
Placebo	Placebo Comparator	Participants who were diagnosed with active mild to moderate UP or UPS will receive 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.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Budesonide	Drug	Budesonide will be administered as per the dose and schedule specified in the respective arm.	Budesonide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Achieved Remission	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).	Week 6

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Voluntarily sign written informed consent.
Male or non-pregnant and non-lactating females.
Confirmed diagnosis (by endoscopy procedure) of active, mild to moderate UP or UPS, with disease extending at least 5 centimeters (cm) but no further than 40 cm from the anal verge.
Must possess a baseline Modified Mayo Disease Activity Index (MMDAI) score between 5 and 10.

Exclusion Criteria:

History or current diagnosis of Crohn's disease and indeterminate colitis.
Prior gastrointestinal surgery except appendectomy and hernia.
Concomitant active gastrointestinal disease or distortion of intestinal anatomy.
History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic or known gallbladder disease.
Uncontrolled, previously diagnosed type 1 or 2 diabetes mellitus.
Uncontrolled abnormal thyroid function.
Unstable significant cardiovascular, endocrine, neurologic or pulmonary disease.
Hemoglobin levels less than (<) 7.5 grams /deciliter (g/dL).
History of sclerosing cholangitis, cirrhosis, or hepatic impairment.
Renal disease manifested by greater than (>) 2.0 milligrams/deciliter (mg/dL) serum creatinine.
History of avascular hip necrosis, active tuberculosis, ocular herpes simplex or ocular varicella zoster, malignant disease, and human immunodeficiency virus (HIV) or hepatitis B or C.
Adrenal insufficiency.
Active systemic or cutaneous infection or toxic megacolon, fistula, perforation or abscess.
History of uncontrolled psychiatric disorders or seizure disorders.
History of asthma requiring ongoing use of inhaled steroids.
Recent history of drug or alcohol abuse.
Positive stool test for bacterial pathogens, Clostridium difficile toxin, or ovum and parasites.
Vaccination within 28 days prior to randomization.
Allergies to budesonide or to any other items used in its preparation.
Participation in another clinical trial in the past 30 days.
Pregnant or at risk of pregnancy.
Taking a prohibited medication. Some medications to treat UP/UPS are prohibited during participation in the study, including laxatives and anti-diarrhea medications; however, oral 5-ASA agents at doses up to 4.8 g/day and daily fiber supplements are allowed. Other medications (e.g., antibiotics, anti-seizure and anti-coagulant medicines) are also prohibited.

Contacts/Locations Module

Name	Affiliation	Role
Study Director	Bausch Health Companies

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27416045	Derived	Bosworth BP, Sandborn WJ, Rubin DT, Harper JR. Baseline Oral 5-ASA Use and Efficacy and Safety of Budesonide Foam in Patients with Ulcerative Proctitis and Ulcerative Proctosigmoiditis: Analysis of 2 Phase 3 Studies. Inflamm Bowel Dis. 2016 Aug;22(8):1881-6. doi: 10.1097/MIB.0000000000000860.
25644096	Derived

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Peripheral Nervous System Agents

Physiological Effects of Drugs

Pharmacologic Actions

Anti-Asthmatic Agents

Respiratory System Agents

Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Inflammatory Agents

Masking Info

Intent-to-treat (ITT) population included all randomized participants.

Arm/Group Information

ID	Title	Description
BG000	Budesonide	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.
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00043.2± 13.94 BG00141.4± 13.24 BG00242.4± 13.60

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00072 BG00180 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00020 BG00122 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0012 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Who Achieved Remission

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).

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

Posted

Number

percentage of participants

Week 6

ID	Title	Description
OG000	Budesonide	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.
OG001	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.

Units	Counts
Participants	OG000133 OG001132

Title

Denominators

Categories

Title	Measurements
	OG00038.3 OG00125.8

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The logistic regression test was used to test for a difference in the percentages between the 2 treatment arms after adjusting for analysis center (country).	Regression, Logistic		0.0324	Threshold for significance at 0.05 level.													Superiority

Secondary

Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6

ITT population included all randomized participants.

Posted

Number

percentage of participants

Week 6

ID	Title	Description
OG000	Budesonide	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.
OG001	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.

Units	Counts

Secondary

Number of Scheduled Assessments With Rectal Bleeding Responder Classification

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.

ITT population included all randomized participants.

Posted

Number

percentage of participants

Weeks 1, 2, 4, and 6

ID	Title	Description
OG000	Budesonide	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.
OG001	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.

Secondary

Percentage of Participants Who Achieved an Endoscopy MMDAI Subscale Score of 0 or 1 at End of Week 6

ITT population included all randomized participants.

Posted

Number

percentage of participants

Week 6

ID	Title	Description
OG000	Budesonide	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.
OG001	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.

Secondary

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

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.

ITT population included all randomized participants.

Posted

Number

percentage of participants

Week 6

ID	Title	Description
OG000	Budesonide	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.
OG001	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.

Secondary

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

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.

ITT population included all randomized participants.

Posted

Number

percentage of participants

Week 6

ID	Title	Description
OG000	Budesonide	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.
OG001	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.

Secondary

Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Endoscopy Subscale Score at End of Week 6

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.

ITT population included all randomized participants.

Posted

Number

percentage of participants

Week 6

ID	Title	Description
OG000	Budesonide	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.
OG001	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.

Secondary

Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score at End of Week 6

ITT population included all randomized participants.

Posted

Number

percentage of participants

Week 6

ID	Title	Description
OG000	Budesonide	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.
OG001	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.

Secondary

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

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.

ITT population included all randomized participants.

Posted

Number

percentage of participants

Week 6

ID	Title	Description
OG000	Budesonide	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.
OG001	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.

Secondary

Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores

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.

ITT population included all randomized participants.

Posted

Mean

Standard Deviation

unit on a scale

Baseline, Week 6

ID	Title	Description
OG000	Budesonide	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.
OG001	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Budesonide	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.	0	134	2	134	66	134
EG001	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.	0	131	3	131	47	131

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Hypersensitivity	Immune system disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA v13.0	Systematic Assessment	This is a gender-specific AE. Only female participants were at risk.	EG0000 affected72 at risk EG0011 affected80 at risk
Arterial thrombosis limb	Vascular disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0011 affected131 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Herpes zoster	Infections and infestations	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0012 affected131 at risk
Proctitis ulcerative	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0014 affected131 at risk
Blood bilirubin increased	Investigations	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0012 affected131 at risk
Tongue geographic	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Syncope	Nervous system disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Flatulence	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0002 affected134 at risk EG0010 affected131 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0012 affected131 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0013 affected131 at risk
Acute sinusitis	Infections and infestations	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Anorectal discomfort	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Dizziness	Nervous system disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0012 affected131 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0012 affected131 at risk
Oedema peripheral	General disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0012 affected131 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Urinary tract infection	Infections and infestations	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0012 affected131 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Nipple pain	Reproductive system and breast disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Pharyngitis	Infections and infestations	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Constipation	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0002 affected134 at risk EG0010 affected131 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0012 affected131 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0012 affected131 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0012 affected131 at risk
Proctalgia	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0011 affected131 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0004 affected134 at risk EG0010 affected131 at risk
Nausea	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0004 affected134 at risk EG0011 affected131 at risk
Gastrointestinal sounds abnormal	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Vomiting	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Dry mouth	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Anal pruritus	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Bronchitis	Infections and infestations	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Nasopharyngitis	Infections and infestations	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Gastroenteritis viral	Infections and infestations	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Acute tonsillitis	Infections and infestations	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0011 affected131 at risk
Influenza	Infections and infestations	MedDRA v13.0	Systematic Assessment		EG0002 affected134 at risk EG0011 affected131 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0013 affected131 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0011 affected131 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Systematic Assessment		EG0002 affected134 at risk EG0010 affected131 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0011 affected131 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Lethargy	Nervous system disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Paraesthesia	Nervous system disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Sciatica	Nervous system disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Non-cardiac chest pain	General disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Fatigue	General disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Application site pain	General disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Hypotension	Vascular disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Cellulitis	Infections and infestations	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0011 affected131 at risk
Eye swelling	Eye disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Conjunctivitis	Eye disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Alanine aminotransferase increased	Investigations	MedDRA v13.0	Systematic Assessment		EG0002 affected134 at risk EG0011 affected131 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0011 affected131 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Blood potassium increased	Investigations	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Blood cortisol decreased	Investigations	MedDRA v13.0	Systematic Assessment		EG00025 affected134 at risk EG0010 affected131 at risk
Blood glucose abnormal	Investigations	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
ACTH stimulation test abnormal	Investigations	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA v13.0	Systematic Assessment		EG0007 affected134 at risk EG0012 affected131 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Ingrown hair	Skin and subcutaneous tissue disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v13.0	Systematic Assessment		EG0002 affected134 at risk EG0010 affected131 at risk
Purpura senile	Skin and subcutaneous tissue disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA v13.0	Systematic Assessment		EG0000 affected134 at risk EG0011 affected131 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v13.0	Systematic Assessment		EG0002 affected134 at risk EG0010 affected131 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0012 affected131 at risk
Headache	Nervous system disorders	MedDRA v13.0	Systematic Assessment		EG0004 affected134 at risk EG0011 affected131 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Depression	Psychiatric disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Sleep disorder	Psychiatric disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Insomnia	Psychiatric disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA v13.0	Systematic Assessment	This is a gender-specific AE. Only female participants were at risk.	EG0001 affected72 at risk EG0010 affected80 at risk
Sexual dysfunction	Reproductive system and breast disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v13.0	Systematic Assessment		EG0001 affected134 at risk EG0010 affected131 at risk

ID	Term
D011349	Proctitis
D011350	Proctocolitis
D014456	Ulcer
D003092	Colitis
D003093	Colitis, Ulcerative
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D012002	Rectal Diseases
D007410	Intestinal Diseases
D003108	Colonic Diseases
D012810	Sigmoid Diseases
D010335	Pathologic Processes
D015212	Inflammatory Bowel Diseases

ID	Term
D019819	Budesonide

Units	Counts
Participants	OG000133 OG001132

Units	Counts
Participants	OG000133 OG001132

Units	Counts
Participants	OG000133 OG001132

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds