Trial Outcomes & Findings for Extension Study for Patients Entered Into Study Infacort 003 (NCT NCT02733367)

Last Updated: 2019-11-05

Results Overview

The primary endpoint was the nature and occurrence of serious adverse events (SAEs) and adverse events (AEs) observed throughout the study. AEs were recorded from the time of the first intake of Infacort until the final visit.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

18 participants

Primary outcome timeframe

29 months

Results posted on

2019-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	Infacort Infacort® granules Infacort®: Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg). This was a non-randomised, open-label, single-group study; all subjects who participated received Infacort. One subject was initially withdrawn from the study, but subsequently re-enrolled.
Overall Study STARTED	18
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Infacort Infacort® granules Infacort®: Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg). This was a non-randomised, open-label, single-group study; all subjects who participated received Infacort. One subject was initially withdrawn from the study, but subsequently re-enrolled.
Overall Study Withdrawal by Subject	6

Baseline Characteristics

Extension Study for Patients Entered Into Study Infacort 003

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infacort n=18 Participants Infacort® granules Infacort®: Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg). This was a non-randomised, open-label, single-group study; all subjects who participated received Infacort. One subject was initially withdrawn from the study, but subsequently re-enrolled.
Age, Categorical <=18 years	18 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	1021.6 days STANDARD_DEVIATION 650.84 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Germany	18 participants n=5 Participants
Body Mass Index	17.02 kg/m^2 STANDARD_DEVIATION 2.083 • n=5 Participants
Body Surface Area	0.582 m^2 STANDARD_DEVIATION 0.1803 • n=5 Participants

PRIMARY outcome

Timeframe: 29 months

Outcome measures

Outcome measures
Measure	Infacort n=18 Participants Infacort® granules Infacort®: Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg). This was a non-randomised, open-label, single-group study; all subjects who participated received Infacort. One subject was initially withdrawn from the study, but subsequently re-enrolled.
Incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Treatment-Emergent Adverse Events (TEAE) - Overall	193 adverse events
Incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Serious TEAEs	9 adverse events
Incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Severe TEAEs	0 adverse events
Incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Moderate TEAEs	42 adverse events
Incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Mild TEAEs	151 adverse events

SECONDARY outcome

Timeframe: 29 months

Population: Reference data for growth velocity is only available for patients \<=6 years old at time of assessment. Therefore n=2 \& not 4 for C1 at Month 11. Subject 001 was re-enrolled so no Visit 10 data available and, therefore, n=1 for C1 at Month 23.

Growth velocity standard deviation score (SDS). Body height/length (cm) was obtained at each visit by specially trained paediatric endocrine nurses or physicians using standard calibrated auxological methods.

Outcome measures

Outcome measures
Measure	Infacort n=10 Participants Infacort® granules Infacort®: Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg). This was a non-randomised, open-label, single-group study; all subjects who participated received Infacort. One subject was initially withdrawn from the study, but subsequently re-enrolled.
Growth Velocity visit 6 - 11th Month	0.6343 Standard Deviation Score Standard Deviation 2.51996
Growth Velocity Visit 10 - 23rd Month	0.9214 Standard Deviation Score Standard Deviation 1.88757

SECONDARY outcome

Timeframe: 29 months

Population: The reason why n=14 at Visit 1 is because of no result for Subjects 005, 010, 017 \& 018. N=12 at Final Visit due to 12 completers.

Cortisol levels measured from dried blood spots. The dried blood spots were analysed for multi-steroids, including cortisol (all subjects). Blood spot absolute laboratory values for the safety population are presented. A dried blood spot sample was collected at the initial and final visits, every month for the first 2 months of the study and thereafter every 6 months (unless required after 3 months).

Outcome measures

Outcome measures
Measure	Infacort n=17 Participants Infacort® granules Infacort®: Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg). This was a non-randomised, open-label, single-group study; all subjects who participated received Infacort. One subject was initially withdrawn from the study, but subsequently re-enrolled.
Cortisol Levels Visit 1	43.329 nmol/L Standard Deviation 48.3217
Cortisol Levels Final Visit	22.022 nmol/L Standard Deviation 27.1323

SECONDARY outcome

Timeframe: 29 months

Population: 'Count of Participants' data below represents the number of subjects that exhibited a change from baseline in their Tanner Development Stage.

The Tanner Development Stage was assessed as an additional analysis in this study. All assessments (breast, genitalia, and pubic hair) were Grade 1 (pre-pubertal) at baseline, with only 1 subject (in Cohort 2) showing a change during the study. Subject 018 showed progression to Grade 2 in the pubic hair category (sparse, pigmented hair mainly on labia).

Outcome measures

Outcome measures
Measure	Infacort n=18 Participants Infacort® granules Infacort®: Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg). This was a non-randomised, open-label, single-group study; all subjects who participated received Infacort. One subject was initially withdrawn from the study, but subsequently re-enrolled.
Number of Participants Exhibiting a Change in Tanner Development Stage	1 Participants

Adverse Events

Infacort

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Infacort n=18 participants at risk Infacort® granules Infacort®: Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg). This was a non-randomised, open-label, single-group study; all subjects who participated received Infacort. One subject was initially withdrawn from the study, but subsequently re-enrolled.
Gastrointestinal disorders Vomiting	5.6% 1/18 • Number of events 2 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Erysipelas	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Gastroenteritis	11.1% 2/18 • Number of events 4 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Urinary Tract Infection	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Pyelonephritis acute	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.

Other adverse events

Other adverse events
Measure	Infacort n=18 participants at risk Infacort® granules Infacort®: Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg). This was a non-randomised, open-label, single-group study; all subjects who participated received Infacort. One subject was initially withdrawn from the study, but subsequently re-enrolled.
Injury, poisoning and procedural complications Thermal burn	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Injury, poisoning and procedural complications Tooth injury	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Injury, poisoning and procedural complications Venomous sting	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Injury, poisoning and procedural complications Injury	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Injury, poisoning and procedural complications Scar	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Vascular disorders Secondary hypertension	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Injury, poisoning and procedural complications Laceration	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Surgical and medical procedures Genitourinary operation	11.1% 2/18 • Number of events 2 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Surgical and medical procedures Circumcision	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Investigations Body temperature increased	11.1% 2/18 • Number of events 6 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Nervous system disorders Headache	5.6% 1/18 • Number of events 3 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Nervous system disorders Paraesthesia	5.6% 1/18 • Number of events 2 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
General disorders Pyrexia	55.6% 10/18 • Number of events 45 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Gastrointestinal disorders Abdominal pain	5.6% 1/18 • Number of events 7 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Gastrointestinal disorders Abdominal pain upper	5.6% 1/18 • Number of events 4 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Gastrointestinal disorders Constipation	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Gastrointestinal disorders Dental caries	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Gastrointestinal disorders Diarrhoea	11.1% 2/18 • Number of events 6 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Gastrointestinal disorders Nausea	5.6% 1/18 • Number of events 3 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Gastrointestinal disorders Vomiting	33.3% 6/18 • Number of events 12 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Reproductive system and breast disorders Vulval disorder	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Skin and subcutaneous tissue disorders Eczema	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Skin and subcutaneous tissue disorders Urticaria	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Skin and subcutaneous tissue disorders Dermatitis allergic	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Musculoskeletal and connective tissue disorders Synovitis	5.6% 1/18 • Number of events 2 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Musculoskeletal and connective tissue disorders Scoliosis	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Bronchitis	11.1% 2/18 • Number of events 6 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Conjunctivitis	27.8% 5/18 • Number of events 6 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Enterovirus infection	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Gastroenteritis	44.4% 8/18 • Number of events 11 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Gastroenteritis viral	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Hand-foot-and-mouth disease	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Influenza	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Laryngitis	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Molluscum contagiosum	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Oral candidiasis	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Otitis media	5.6% 1/18 • Number of events 2 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Otitis media viral	16.7% 3/18 • Number of events 3 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Pharyngitis	11.1% 2/18 • Number of events 2 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Pharyngotonsilitis	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Respiratory tract infection	11.1% 2/18 • Number of events 2 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Rhinitis	11.1% 2/18 • Number of events 2 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Roseola	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Tonsilitis	16.7% 3/18 • Number of events 3 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Viral infection	33.3% 6/18 • Number of events 6 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Viral upper respiratory tract infection	38.9% 7/18 • Number of events 21 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Scarlet fever	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.
Infections and infestations Upper respiratory tract infection	5.6% 1/18 • Number of events 1 • Adverse events were recorded from the time of the first intake of Infacort in this study until the final study visit (i.e. 29 months). Details of any adverse events were collected, including date of onset, end date, frequency, severity, seriousness, relationship to Infacort, action taken, and outcome. Any adverse event was followed, whenever possible, until it returned to the baseline condition or became stable with no further change expected.

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