Trial Outcomes & Findings for Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea (NCT NCT01143272)
NCT ID: NCT01143272
Last Updated: 2016-07-18
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
477 participants
Primary outcome timeframe
29 months
Results posted on
2016-07-18
Participant Flow
Participant milestones
| Measure |
Saccharomyces Boulardii
Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule
|
Microcristallin Cellulose
Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
246
|
231
|
|
Overall Study
COMPLETED
|
246
|
231
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea
Baseline characteristics by cohort
| Measure |
Saccharomyces Boulardii
n=246 Participants
Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule
|
Microcristallin Cellulose
n=231 Participants
Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo
|
Total
n=477 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 17.8 • n=7 Participants
|
58.4 years
STANDARD_DEVIATION 17.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
140 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
246 participants
n=5 Participants
|
231 participants
n=7 Participants
|
477 participants
n=5 Participants
|
|
Body height
|
171.8 cm
STANDARD_DEVIATION 9.4 • n=5 Participants
|
171.7 cm
STANDARD_DEVIATION 10.0 • n=7 Participants
|
171.7 cm
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Body weight
|
83.1 kg
STANDARD_DEVIATION 17.0 • n=5 Participants
|
83.0 kg
STANDARD_DEVIATION 18.1 • n=7 Participants
|
83.0 kg
STANDARD_DEVIATION 17.5 • n=5 Participants
|
|
Body mass index
|
28.1 kg/m^2
STANDARD_DEVIATION 5.2 • n=5 Participants
|
28.1 kg/m^2
STANDARD_DEVIATION 5.6 • n=7 Participants
|
28.1 kg/m^2
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
C-reactive protein (CRP)
|
71.0 mg/L
STANDARD_DEVIATION 89.3 • n=5 Participants
|
72.2 mg/L
STANDARD_DEVIATION 98.9 • n=7 Participants
|
71.6 mg/L
STANDARD_DEVIATION 93.9 • n=5 Participants
|
|
Leukocyte count
|
10.3 10^9 cells/L
STANDARD_DEVIATION 4.6 • n=5 Participants
|
11.4 10^9 cells/L
STANDARD_DEVIATION 6.7 • n=7 Participants
|
10.8 10^9 cells/L
STANDARD_DEVIATION 5.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 29 monthsOutcome measures
| Measure |
Saccharomyces Boulardii
n=246 Participants
Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule
|
Microcristallin Cellulose
n=231 Participants
Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo
|
|---|---|---|
|
Total Number of Antibiotic-associated Diarrhea Episodes
|
21 Episodes
|
19 Episodes
|
SECONDARY outcome
Timeframe: 29 monthsOutcome measures
| Measure |
Saccharomyces Boulardii
n=246 Participants
Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule
|
Microcristallin Cellulose
n=231 Participants
Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo
|
|---|---|---|
|
Total Number of Clostridium Difficile-associated Diarrhea Episodes
|
2 episodes
|
2 episodes
|
SECONDARY outcome
Timeframe: 29 monthsOutcome measures
| Measure |
Saccharomyces Boulardii
n=246 Participants
Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule
|
Microcristallin Cellulose
n=231 Participants
Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo
|
|---|---|---|
|
Total Number of Antibiotic-associated Diarrhea Episodes Without Evidence of Clostridium Difficile (Toxins)
|
19 episodes
|
17 episodes
|
SECONDARY outcome
Timeframe: 29 monthsOutcome measures
| Measure |
Saccharomyces Boulardii
n=246 Participants
Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule
|
Microcristallin Cellulose
n=231 Participants
Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo
|
|---|---|---|
|
Incidence Density of Antibiotic-associated Diarrhea
|
0.78 cases per year
|
0.64 cases per year
|
SECONDARY outcome
Timeframe: 29 monthsOutcome measures
| Measure |
Saccharomyces Boulardii
n=246 Participants
Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule
|
Microcristallin Cellulose
n=231 Participants
Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo
|
|---|---|---|
|
Average Duration of Antibiotic-associated Diarrhoea and Clostridium Difficile-associated Diarrhea
|
4.48 days
Standard Deviation 4.13
|
4.26 days
Standard Deviation 3.85
|
SECONDARY outcome
Timeframe: 29 monthsOutcome measures
| Measure |
Saccharomyces Boulardii
n=246 Participants
Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule
|
Microcristallin Cellulose
n=231 Participants
Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo
|
|---|---|---|
|
Average Number of Bowel Movements in Patients With Antibiotic-associated Diarrhoea and Clostridium Difficile-associated Diarrhea
|
4.48 bowel movements per day
Standard Deviation 3.82
|
4.07 bowel movements per day
Standard Deviation 3.13
|
SECONDARY outcome
Timeframe: 29 monthsOutcome measures
| Measure |
Saccharomyces Boulardii
n=246 Participants
Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule
|
Microcristallin Cellulose
n=231 Participants
Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo
|
|---|---|---|
|
Total Number of Discontinuation or Change of Initially Prescribed Antibiotic
|
14 participants
|
7 participants
|
Adverse Events
Saccharomyces Boulardii
Serious events: 9 serious events
Other events: 9 other events
Deaths: 0 deaths
Microcristallin Cellulose
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Saccharomyces Boulardii
n=245 participants at risk
Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule
|
Microcristallin Cellulose
n=222 participants at risk
Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Duodenal perforation
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
General disorders
Sudden cardiac death
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Infections and infestations
Sepsis
|
0.82%
2/245 • Number of events 2
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Renal and urinary disorders
Renal failure
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.45%
1/222 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Infections and infestations
Pulmonary empyema
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/245
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.45%
1/222 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/245
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.45%
1/222 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
Other adverse events
| Measure |
Saccharomyces Boulardii
n=245 participants at risk
Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule
|
Microcristallin Cellulose
n=222 participants at risk
Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Placebo: Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.45%
1/222 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/245
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.45%
1/222 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Gastrointestinal disorders
Nausea
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.90%
2/222 • Number of events 2
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Gastrointestinal disorders
Vomiting
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.45%
1/222 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Gastrointestinal disorders
Flatulence
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Gastrointestinal disorders
Glossodynia
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Gastrointestinal disorders
Malaise
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Investigations
Blood pressure increased
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.41%
1/245 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.82%
2/245 • Number of events 2
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.00%
0/222
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/245
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.45%
1/222 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/245
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.45%
1/222 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Investigations
Body temperature increased
|
0.00%
0/245
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.45%
1/222 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/245
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
0.45%
1/222 • Number of events 1
Ten participants did not take trial drug and were excluded from the safety analysis population. Therefore, the numbers of participants at risk are 245 and 222, while the numbers in the participant flow are 246 and 231.
|
Additional Information
Stephan Ehrhardt
Johns Hopkins Bloomberg School of Public Health
Phone: 410-502-3872
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place