Trial Outcomes & Findings for Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II (NCT NCT02911935)
NCT ID: NCT02911935
Last Updated: 2022-06-07
Results Overview
Episodes of wheezing were captured at each of the study telephone interviews and clinic visits using the question, "Has your child's chest sounded wheezy or whistling (with and without a cold)?". A new wheezing episode was defined if at least 7 days without wheezing had been reported since the previous episode.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
200 participants
Primary outcome timeframe
Follow up duration of 18-48 months
Results posted on
2022-06-07
Participant Flow
Participant milestones
| Measure |
Azithromycin
Participants received Azithromycin 10 mg/kg/d orally for 7 days and 5 mg/kg/d orally for additional 7 days
|
Placebo
Participants received Azithromycin placebo orally daily for 14 days
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
99
|
|
Overall Study
COMPLETED
|
96
|
92
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
Azithromycin
Participants received Azithromycin 10 mg/kg/d orally for 7 days and 5 mg/kg/d orally for additional 7 days
|
Placebo
Participants received Azithromycin placebo orally daily for 14 days
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
7
|
Baseline Characteristics
One participant in Placebo arm refused to provide race/ethnicity information
Baseline characteristics by cohort
| Measure |
Azithromycin
n=101 Participants
Participants orally received Azithromycin 10 mg/kg/d for 7 days and 5 mg/kg/d for additional 7 days
|
Placebo
n=99 Participants
Participants orally received Azithromycin placebo daily for 14 days
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.9 months
n=101 Participants
|
2.8 months
n=99 Participants
|
3.3 months
n=200 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=101 Participants
|
44 Participants
n=99 Participants
|
91 Participants
n=200 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=101 Participants
|
55 Participants
n=99 Participants
|
109 Participants
n=200 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · African American
|
19 Participants
n=101 Participants • One participant in Placebo arm refused to provide race/ethnicity information
|
21 Participants
n=98 Participants • One participant in Placebo arm refused to provide race/ethnicity information
|
40 Participants
n=199 Participants • One participant in Placebo arm refused to provide race/ethnicity information
|
|
Race/Ethnicity, Customized
Race and ethnicity · Caucasian
|
72 Participants
n=101 Participants • One participant in Placebo arm refused to provide race/ethnicity information
|
72 Participants
n=98 Participants • One participant in Placebo arm refused to provide race/ethnicity information
|
144 Participants
n=199 Participants • One participant in Placebo arm refused to provide race/ethnicity information
|
|
Race/Ethnicity, Customized
Race and ethnicity · More than one race
|
10 Participants
n=101 Participants • One participant in Placebo arm refused to provide race/ethnicity information
|
5 Participants
n=98 Participants • One participant in Placebo arm refused to provide race/ethnicity information
|
15 Participants
n=199 Participants • One participant in Placebo arm refused to provide race/ethnicity information
|
|
Region of Enrollment
United States
|
101 Participants
n=101 Participants
|
99 Participants
n=99 Participants
|
200 Participants
n=200 Participants
|
|
Birth weight
|
3.3 kg
STANDARD_DEVIATION 0.5 • n=101 Participants
|
3.4 kg
STANDARD_DEVIATION 0.5 • n=99 Participants
|
3.3 kg
STANDARD_DEVIATION 0.5 • n=200 Participants
|
|
Birth by cesarean section
|
29 Participants
n=101 Participants
|
28 Participants
n=99 Participants
|
57 Participants
n=200 Participants
|
|
Gestational age at birth
|
38.9 weeks
STANDARD_DEVIATION 1.2 • n=101 Participants
|
38.8 weeks
STANDARD_DEVIATION 1.2 • n=99 Participants
|
38.8 weeks
STANDARD_DEVIATION 1.2 • n=200 Participants
|
|
Maternal smoking during pregnancy
|
19 Participants
n=101 Participants
|
13 Participants
n=99 Participants
|
32 Participants
n=200 Participants
|
|
History of breast feeding
|
75 Participants
n=101 Participants
|
80 Participants
n=99 Participants
|
155 Participants
n=200 Participants
|
|
History of eczema
|
16 Participants
n=101 Participants
|
13 Participants
n=99 Participants
|
29 Participants
n=200 Participants
|
|
Food allergy diagnosis
|
3 Participants
n=101 Participants
|
5 Participants
n=99 Participants
|
8 Participants
n=200 Participants
|
|
Parental history of asthma
|
33 Participants
n=101 Participants
|
39 Participants
n=99 Participants
|
72 Participants
n=200 Participants
|
|
Parental history of other atopic diseases
|
60 Participants
n=101 Participants
|
69 Participants
n=99 Participants
|
129 Participants
n=200 Participants
|
|
Pet exposure
|
59 Participants
n=101 Participants
|
71 Participants
n=99 Participants
|
130 Participants
n=200 Participants
|
|
Tobacco smoke exposure
|
40 Participants
n=101 Participants
|
26 Participants
n=99 Participants
|
66 Participants
n=200 Participants
|
|
Duration of hospital stay
|
51 hours
n=101 Participants • Two patients with missing values were excluded from the analysis population.
|
56 hours
n=97 Participants • Two patients with missing values were excluded from the analysis population.
|
52 hours
n=198 Participants • Two patients with missing values were excluded from the analysis population.
|
|
Duration of oxygen requirement, if required
|
46 hours
n=57 Participants • The analysis population only included infants were supplemented with oxygen if they had oxygen saturation of less than 90% on room air.
|
48 hours
n=57 Participants • The analysis population only included infants were supplemented with oxygen if they had oxygen saturation of less than 90% on room air.
|
47 hours
n=114 Participants • The analysis population only included infants were supplemented with oxygen if they had oxygen saturation of less than 90% on room air.
|
|
Lowest oxygen saturation on room air
|
90.6 percentage of oxygen saturation
STANDARD_DEVIATION 4.4 • n=101 Participants • Three patients with missing values were excluded from the analysis population.
|
90.7 percentage of oxygen saturation
STANDARD_DEVIATION 5.2 • n=96 Participants • Three patients with missing values were excluded from the analysis population.
|
90.7 percentage of oxygen saturation
STANDARD_DEVIATION 4.8 • n=197 Participants • Three patients with missing values were excluded from the analysis population.
|
|
Need for BiPAP ventilation
|
8 Participants
n=101 Participants • Two patients with missing values were excluded from the analysis population.
|
5 Participants
n=97 Participants • Two patients with missing values were excluded from the analysis population.
|
13 Participants
n=198 Participants • Two patients with missing values were excluded from the analysis population.
|
|
Bronchiolitis severity score
|
5.3 Scores on a scale
STANDARD_DEVIATION 1.8 • n=101 Participants
|
5.2 Scores on a scale
STANDARD_DEVIATION 1.8 • n=99 Participants
|
5.2 Scores on a scale
STANDARD_DEVIATION 1.8 • n=200 Participants
|
|
Other nonstudy antibiotic (nonmacrolide) use
|
30 Participants
n=101 Participants
|
28 Participants
n=99 Participants
|
58 Participants
n=200 Participants
|
PRIMARY outcome
Timeframe: Follow up duration of 18-48 monthsPopulation: A total of 188 participants (96 in the azithromycin group and 92 in the placebo group) had at least one follow-up visit were included in the final primary outcome analysis.
Episodes of wheezing were captured at each of the study telephone interviews and clinic visits using the question, "Has your child's chest sounded wheezy or whistling (with and without a cold)?". A new wheezing episode was defined if at least 7 days without wheezing had been reported since the previous episode.
Outcome measures
| Measure |
Azithromycin
n=96 Participants
Participants orally received Azithromycin 10 mg/kg/d for 7 days and 5 mg/kg/d for additional 7 days
|
Placebo
n=92 Participants
Participants orally received Azithromycin placebo daily for 14 days
|
|---|---|---|
|
Number of Participants Who Experienced the Occurrence of a Third Episode of Post-RSV Wheezing (Recurrent Wheeze)
|
45 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Follow up duration of 18-48 monthsPopulation: A total of 188 participants (96 in the azithromycin group and 92 in the placebo group) had at least one follow-up visit were included in the analysis.
Physician asthma diagnosis were captured at each of the study telephone interviews and clinic visits using the question, "Has the doctor told you that your child has asthma?".
Outcome measures
| Measure |
Azithromycin
n=96 Participants
Participants orally received Azithromycin 10 mg/kg/d for 7 days and 5 mg/kg/d for additional 7 days
|
Placebo
n=92 Participants
Participants orally received Azithromycin placebo daily for 14 days
|
|---|---|---|
|
Number of Participants Who Had Physician Asthma Diagnosis
|
15 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Follow up duration of 18-48 monthsPopulation: A total of 188 participants (96 in the azithromycin group and 92 in the placebo group) had at least one follow-up visit were included in this analysis.
The number of days with respiratory symptoms were captured during clinic visits and by telephone interviews every other month using two questions, "Does your child have coughing, wheezing, shortness of breath or chest tightness during the daytime?", "If yes, estimate the number of days". We used a negative binomial regression analysis with an offset term to adjust for duration of follow-up to get the annualized rate estimate.
Outcome measures
| Measure |
Azithromycin
n=96 Participants
Participants orally received Azithromycin 10 mg/kg/d for 7 days and 5 mg/kg/d for additional 7 days
|
Placebo
n=92 Participants
Participants orally received Azithromycin placebo daily for 14 days
|
|---|---|---|
|
Annualized Number of Days With Respiratory Symptoms (Wheezing, Cough, or Shortness of Breath)
|
26.2 days per year
Interval 21.0 to 32.8
|
22.2 days per year
Interval 17.7 to 27.9
|
SECONDARY outcome
Timeframe: Follow up duration of 18-48 monthsPopulation: A total of 188 participants (96 in the azithromycin group and 92 in the placebo group) had at least one follow-up visit were included in this analysis.
The number of days with albuterol use were captured during clinic visits and by telephone interviews every other month using two questions, "Has your child taken Albuterol (also known as Ventolin, Pro-air, Proventil)?" and "please estimate # of days your child had albuterol treatments since the last visit". We used a negative binomial regression analysis with an offset term to adjust for duration of follow-up to get the annualized rate estimate.
Outcome measures
| Measure |
Azithromycin
n=96 Participants
Participants orally received Azithromycin 10 mg/kg/d for 7 days and 5 mg/kg/d for additional 7 days
|
Placebo
n=92 Participants
Participants orally received Azithromycin placebo daily for 14 days
|
|---|---|---|
|
Annualized Number of Days With Albuterol Use
|
4 days per year
Interval 2.4 to 6.6
|
3.3 days per year
Interval 2.0 to 5.4
|
SECONDARY outcome
Timeframe: Follow up duration of 18-48 monthsPopulation: A total of 188 participants (96 in the azithromycin group and 92 in the placebo group) had at least one follow-up visit were included in this analysis.
The number of oral corticosteroid courses were captured during clinic visits and by telephone interviews every other month using two questions, "Has your child taken Oral steroids (Prednisone, Prednisolone, Orapred, Dexamethasone)?" and "how many separate courses of steroids has your child had since the last visit?". We used a negative binomial regression analysis with an offset term to adjust for duration of follow-up to get the annualized rate estimate.
Outcome measures
| Measure |
Azithromycin
n=96 Participants
Participants orally received Azithromycin 10 mg/kg/d for 7 days and 5 mg/kg/d for additional 7 days
|
Placebo
n=92 Participants
Participants orally received Azithromycin placebo daily for 14 days
|
|---|---|---|
|
Annualized Number of Oral Corticosteroid Courses
|
0.23 courses per year
Interval 0.15 to 0.35
|
0.17 courses per year
Interval 0.1 to 0.27
|
SECONDARY outcome
Timeframe: Follow up duration of 18-48 monthsPopulation: A total of 188 participants (96 in the azithromycin group and 92 in the placebo group) had at least one follow-up visit were included in this analysis.
The number of antibiotic courses were captured during clinic visits and by telephone interviews every other month using two questions, "Has your child taken any antibiotics?" and "How many separate prescriptions has your child taken of an antibiotic(s)?". We used a negative binomial regression analysis with an offset term to adjust for duration of follow-up to get the annualized rate estimate.
Outcome measures
| Measure |
Azithromycin
n=96 Participants
Participants orally received Azithromycin 10 mg/kg/d for 7 days and 5 mg/kg/d for additional 7 days
|
Placebo
n=92 Participants
Participants orally received Azithromycin placebo daily for 14 days
|
|---|---|---|
|
Annualized Number of Antibiotic Courses
|
1.2 courses per year
Interval 0.95 to 1.4
|
1.3 courses per year
Interval 1.0 to 1.5
|
SECONDARY outcome
Timeframe: Follow up duration of 18-48 monthsSerious Adverse Event were captured during clinic visits and by telephone interviews every other month using designed SAE form.
Outcome measures
| Measure |
Azithromycin
n=101 Participants
Participants orally received Azithromycin 10 mg/kg/d for 7 days and 5 mg/kg/d for additional 7 days
|
Placebo
n=99 Participants
Participants orally received Azithromycin placebo daily for 14 days
|
|---|---|---|
|
Number of Participants Who Experienced Serious Adverse Events
|
15 Participants
|
16 Participants
|
Adverse Events
Azithromycin
Serious events: 15 serious events
Other events: 73 other events
Deaths: 0 deaths
Placebo
Serious events: 16 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azithromycin
n=101 participants at risk
Participants orally received azithromycin 10mg/kg/day for 7 days; then oral azithromycin 5mg/kg/day for 7 additional days
|
Placebo
n=99 participants at risk
Participants orally received placebo daily for 14 days.
|
|---|---|---|
|
Gastrointestinal disorders
Accidental drug ingestion
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Gastrointestinal disorders
Acute appendicitis
|
0.99%
1/101 • Number of events 1 • Follow up duration of 18-48 months
|
0.00%
0/99 • Follow up duration of 18-48 months
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
General disorders
ED visit for gastroenteritis
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Infections and infestations
High Fever
|
0.00%
0/101 • Follow up duration of 18-48 months
|
2.0%
2/99 • Number of events 2 • Follow up duration of 18-48 months
|
|
Musculoskeletal and connective tissue disorders
Hospitalization for bone fracutre
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for respiratory distress
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for wheezing
|
4.0%
4/101 • Number of events 5 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 2 • Follow up duration of 18-48 months
|
|
Nervous system disorders
Hospitalized for observation and video EEG
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Infections and infestations
Preseptal Cellulitis
|
0.99%
1/101 • Number of events 1 • Follow up duration of 18-48 months
|
0.00%
0/99 • Follow up duration of 18-48 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure/distress
|
0.99%
1/101 • Number of events 1 • Follow up duration of 18-48 months
|
0.00%
0/99 • Follow up duration of 18-48 months
|
|
General disorders
Scheduled surgery for bilateral myringotomy with tube insertion and bilateral Adenotonsillectomy
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Respiratory, thoracic and mediastinal disorders
Transferred to PICU during respiratory infection
|
0.99%
1/101 • Number of events 1 • Follow up duration of 18-48 months
|
3.0%
3/99 • Number of events 3 • Follow up duration of 18-48 months
|
|
Musculoskeletal and connective tissue disorders
Hospitalization with hematoma
|
0.99%
1/101 • Number of events 1 • Follow up duration of 18-48 months
|
0.00%
0/99 • Follow up duration of 18-48 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized after bronchoscopy
|
0.99%
1/101 • Number of events 1 • Follow up duration of 18-48 months
|
0.00%
0/99 • Follow up duration of 18-48 months
|
|
Infections and infestations
Hospitalized for a UTI and fever
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
General disorders
Hospitalized for dehydration
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized for observation following bronchoscopy, BAL and EGD with biopsies
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
General disorders
Hospitalized for planned right open pyeloplasty and observation
|
0.99%
1/101 • Number of events 1 • Follow up duration of 18-48 months
|
0.00%
0/99 • Follow up duration of 18-48 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized with respiratory infection
|
5.9%
6/101 • Number of events 6 • Follow up duration of 18-48 months
|
3.0%
3/99 • Number of events 4 • Follow up duration of 18-48 months
|
|
Gastrointestinal disorders
Hospitalized with bloody diarrhea
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Nervous system disorders
Hospitalized with questionable seizurelike activity
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized with pneumonia
|
0.99%
1/101 • Number of events 2 • Follow up duration of 18-48 months
|
0.00%
0/99 • Follow up duration of 18-48 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized for asthma exacerbation
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 3 • Follow up duration of 18-48 months
|
Other adverse events
| Measure |
Azithromycin
n=101 participants at risk
Participants orally received azithromycin 10mg/kg/day for 7 days; then oral azithromycin 5mg/kg/day for 7 additional days
|
Placebo
n=99 participants at risk
Participants orally received placebo daily for 14 days.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
2/101 • Number of events 2 • Follow up duration of 18-48 months
|
5.1%
5/99 • Number of events 5 • Follow up duration of 18-48 months
|
|
Blood and lymphatic system disorders
Abnormal Neutrophil Count
|
0.99%
1/101 • Number of events 1 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Blood and lymphatic system disorders
Abnormal platelet count
|
4.0%
4/101 • Number of events 4 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Infections and infestations
Acute Otitis Media
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Gastrointestinal disorders
GERD
|
0.99%
1/101 • Number of events 1 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Gastrointestinal disorders
Loose stool
|
3.0%
3/101 • Number of events 3 • Follow up duration of 18-48 months
|
2.0%
2/99 • Number of events 2 • Follow up duration of 18-48 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.9%
6/101 • Number of events 6 • Follow up duration of 18-48 months
|
5.1%
5/99 • Number of events 5 • Follow up duration of 18-48 months
|
|
Eye disorders
Blocked tear duct
|
0.99%
1/101 • Number of events 1 • Follow up duration of 18-48 months
|
0.00%
0/99 • Follow up duration of 18-48 months
|
|
General disorders
Blood in urine
|
0.99%
1/101 • Number of events 1 • Follow up duration of 18-48 months
|
0.00%
0/99 • Follow up duration of 18-48 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/101 • Follow up duration of 18-48 months
|
3.0%
3/99 • Number of events 3 • Follow up duration of 18-48 months
|
|
Blood and lymphatic system disorders
Decreased Neutrophil count
|
0.99%
1/101 • Number of events 1 • Follow up duration of 18-48 months
|
0.00%
0/99 • Follow up duration of 18-48 months
|
|
Gastrointestinal disorders
Diarrhea
|
29.7%
30/101 • Number of events 31 • Follow up duration of 18-48 months
|
21.2%
21/99 • Number of events 21 • Follow up duration of 18-48 months
|
|
Infections and infestations
Ear infection
|
13.9%
14/101 • Number of events 14 • Follow up duration of 18-48 months
|
14.1%
14/99 • Number of events 16 • Follow up duration of 18-48 months
|
|
Infections and infestations
Fever
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Nervous system disorders
Fussy
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Infections and infestations
Pink eye
|
0.99%
1/101 • Number of events 1 • Follow up duration of 18-48 months
|
0.00%
0/99 • Follow up duration of 18-48 months
|
|
General disorders
Pneumonia
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
8/101 • Number of events 9 • Follow up duration of 18-48 months
|
6.1%
6/99 • Number of events 7 • Follow up duration of 18-48 months
|
|
Respiratory, thoracic and mediastinal disorders
Severe obstructive sleep apnea
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Nervous system disorders
Sleep myoclonus
|
0.99%
1/101 • Number of events 1 • Follow up duration of 18-48 months
|
0.00%
0/99 • Follow up duration of 18-48 months
|
|
Infections and infestations
Strep infection
|
0.00%
0/101 • Follow up duration of 18-48 months
|
1.0%
1/99 • Number of events 1 • Follow up duration of 18-48 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
32.7%
33/101 • Number of events 33 • Follow up duration of 18-48 months
|
22.2%
22/99 • Number of events 23 • Follow up duration of 18-48 months
|
|
Gastrointestinal disorders
Vomiting
|
9.9%
10/101 • Number of events 10 • Follow up duration of 18-48 months
|
7.1%
7/99 • Number of events 7 • Follow up duration of 18-48 months
|
Additional Information
Dr. Avraham Beigelman
Washington University School of Medicine.
Phone: 314-454-2694
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place