Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis (EPIC)

This study has been completed.
Sponsor:
Collaborators:
Cystic Fibrosis Foundation
CF Therapeutics Development Network Coordinating Center
Information provided by (Responsible Party):
Bonnie Ramsey, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT00097773
First received: November 30, 2004
Last updated: January 28, 2014
Last verified: January 2014
Results First Received: June 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Cystic Fibrosis
Pulmonary Disease, Chronic Obstructive
Interventions: Drug: Tobramycin solution for inhalation (TOBI)
Drug: Oral placebo
Drug: Oral ciprofloxacin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was conducted from December 2004 to June 2009 from 55 Cystic Fibrosis Foundation accredited clinical centers throughout the US

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cycled TOBI and Oral Placebo Tobramycin solution for inhalation (TOBI) and oral placebo for six consecutive quarterly cycles
Cycled TOBI and Oral Ciprofloxacin Tobramycin solution for inhalation (TOBI) and oral ciprofloxacin for six consecutive quarterly cycles
Culture-Based TOBI and Oral Ciprofloxacin Tobramycin solution for inhalation (TOBI) and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
Culture-Based TOBI and Oral Placebo Tobramycin solution for inhalation (TOBI) and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)

Participant Flow:   Overall Study
    Cycled TOBI and Oral Placebo     Cycled TOBI and Oral Ciprofloxacin     Culture-Based TOBI and Oral Ciprofloxacin     Culture-Based TOBI and Oral Placebo  
STARTED     76     76     76     76  
COMPLETED     68     68     68     73  
NOT COMPLETED     8     8     8     3  
Lost to Follow-up                 2                 2                 0                 1  
Physician Decision                 2                 2                 3                 1  
Withdrawal by Subject                 3                 3                 3                 1  
Adverse Event                 0                 1                 0                 0  
Unknown                 1                 0                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat

Reporting Groups
  Description
Cycled TIS w/Placebo TOBI and oral placebo for six consecutive quarterly cycles
Cycled TIS w/Cipro TOBI and oral ciprofloxacin for six consecutive quarterly cycles
Culture-Based TIS w/Placebo TOBI and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
Culture-Based TIS w/Cipro TOBI and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
Total Total of all reporting groups

Baseline Measures
    Cycled TIS w/Placebo     Cycled TIS w/Cipro     Culture-Based TIS w/Placebo     Culture-Based TIS w/Cipro     Total  
Number of Participants  
[units: participants]
  76     76     76     76     304  
Age  
[units: participants]
         
<=18 years     76     76     76     76     304  
Between 18 and 65 years     0     0     0     0     0  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  5.8  ± 3.43     5.9  ± 3.28     6.0  ± 3.74     5.0  ± 3.58     5.7  ± 3.51  
Gender  
[units: participants]
         
Female     45     32     40     37     154  
Male     31     44     36     39     150  
Region of Enrollment  
[units: participants]
         
United States     76     76     76     76     304  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization   [ Time Frame: Measured over the 18 month study ]

2.  Secondary:   Proportion of Participants With a Pa Positive Culture   [ Time Frame: Week 10 (after initial treatment course for Pa) through Month 18 ]

3.  Secondary:   Number of Participants With a Pulmonary Exacerbation Requiring Oral, Inhaled, or Oral Antibiotics   [ Time Frame: Measured over the 18 month time period ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Randomization through Month 18
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Cycled TIS w/Placebo TOBI and oral placebo for six consecutive quarterly cycles
Cycled TIS w/Cipro TOBI and oral ciprofloxacin for six consecutive quarterly cycles
Culture-Based TIS w/Placebo TOBI and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (PA)
Culture-Based TIS w/Cipro TOBI and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for PA

Other Adverse Events
    Cycled TIS w/Placebo     Cycled TIS w/Cipro     Culture-Based TIS w/Placebo     Culture-Based TIS w/Cipro  
Total, other (not including serious) adverse events          
# participants affected / at risk     65/76     67/76     65/76     73/76  
Blood and lymphatic system disorders          
Lymphadenopathy * 1        
# participants affected / at risk     12/76 (15.79%)     8/76 (10.53%)     13/76 (17.11%)     11/76 (14.47%)  
# events     13     8     14     12  
Ear and labyrinth disorders          
Ear Pain * 1        
# participants affected / at risk     8/76 (10.53%)     9/76 (11.84%)     11/76 (14.47%)     17/76 (22.37%)  
# events     13     11     18     19  
Middle Ear Effusion * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)     6/76 (7.89%)  
# events     0     0     0     8  
Tympanic Membrane Disorder * 1        
# participants affected / at risk     6/76 (7.89%)     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)  
# events     6     0     0     0  
Eye disorders          
Conjunctivitis * 1        
# participants affected / at risk     0/76 (0.00%)     6/76 (7.89%)     10/76 (13.16%)     4/76 (5.26%)  
# events     0     6     10     5  
Eye Discharge * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)     4/76 (5.26%)  
# events     0     0     0     8  
Ocular Hyperaemia * 1        
# participants affected / at risk     0/76 (0.00%)     4/76 (5.26%)     4/76 (5.26%)     0/76 (0.00%)  
# events     0     5     4     0  
Gastrointestinal disorders          
Abdominal Discomfort * 1        
# participants affected / at risk     7/76 (9.21%)     5/76 (6.58%)     4/76 (5.26%)     0/76 (0.00%)  
# events     8     8     4     0  
Abdominal Distension * 1        
# participants affected / at risk     4/76 (5.26%)     0/76 (0.00%)     4/76 (5.26%)     4/76 (5.26%)  
# events     4     0     4     7  
Abdominal Pain * 1        
# participants affected / at risk     17/76 (22.37%)     12/76 (15.79%)     16/76 (21.05%)     12/76 (15.79%)  
# events     20     15     21     15  
Abdominal Pain Upper * 1        
# participants affected / at risk     14/76 (18.42%)     18/76 (23.68%)     15/76 (19.74%)     17/76 (22.37%)  
# events     22     34     35     30  
Constipation * 1        
# participants affected / at risk     6/76 (7.89%)     9/76 (11.84%)     13/76 (17.11%)     11/76 (14.47%)  
# events     8     15     14     13  
Diarrhoea * 1        
# participants affected / at risk     15/76 (19.74%)     22/76 (28.95%)     22/76 (28.95%)     26/76 (34.21%)  
# events     24     40     24     49  
Flatulence * 1        
# participants affected / at risk     4/76 (5.26%)     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)  
# events     4     0     0     0  
Frequent Bowel Movements * 1        
# participants affected / at risk     4/76 (5.26%)     0/76 (0.00%)     0/76 (0.00%)     5/76 (6.58%)  
# events     4     0     0     6  
Malabsorption * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)     5/76 (6.58%)  
# events     0     0     0     5  
Nausea * 1        
# participants affected / at risk     0/76 (0.00%)     12/76 (15.79%)     6/76 (7.89%)     7/76 (9.21%)  
# events     0     21     7     11  
Oral Pain * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)     4/76 (5.26%)  
# events     0     0     0     6  
Post-Tussive Vomiting * 1        
# participants affected / at risk     5/76 (6.58%)     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)  
# events     5     0     0     0  
Steatorrhoea * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)     4/76 (5.26%)  
# events     0     0     0     5  
Teething * 1        
# participants affected / at risk     4/76 (5.26%)     0/76 (0.00%)     0/76 (0.00%)     5/76 (6.58%)  
# events     5     0     0     5  
Toothache * 1        
# participants affected / at risk     0/76 (0.00%)     4/76 (5.26%)     0/76 (0.00%)     0/76 (0.00%)  
# events     0     6     0     0  
Vomiting * 1        
# participants affected / at risk     29/76 (38.16%)     30/76 (39.47%)     35/76 (46.05%)     37/76 (48.68%)  
# events     52     52     49     70  
General disorders          
Asthenia * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     4/76 (5.26%)     0/76 (0.00%)  
# events     0     0     4     0  
Chest Pain * 1        
# participants affected / at risk     6/76 (7.89%)     7/76 (9.21%)     6/76 (7.89%)     11/76 (14.47%)  
# events     8     8     8     15  
Chills * 1        
# participants affected / at risk     0/76 (0.00%)     4/76 (5.26%)     0/76 (0.00%)     0/76 (0.00%)  
# events     0     5     0     0  
Crepitations * 1        
# participants affected / at risk     0/76 (0.00%)     5/76 (6.58%)     0/76 (0.00%)     4/76 (5.26%)  
# events     0     6     0     4  
Exercise Tolerance Decreased * 1        
# participants affected / at risk     4/76 (5.26%)     6/76 (7.89%)     0/76 (0.00%)     0/76 (0.00%)  
# events     4     7     0     0  
Fatigue * 1        
# participants affected / at risk     11/76 (14.47%)     7/76 (9.21%)     13/76 (17.11%)     10/76 (13.16%)  
# events     19     9     21     14  
Irritability * 1        
# participants affected / at risk     4/76 (5.26%)     4/76 (5.26%)     0/76 (0.00%)     8/76 (10.53%)  
# events     4     5     0     11  
Pain * 1        
# participants affected / at risk     5/76 (6.58%)     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)  
# events     6     0     0     0  
Pyrexia * 1        
# participants affected / at risk     46/76 (60.53%)     45/76 (59.21%)     57/76 (75.00%)     57/76 (75.00%)  
# events     85     107     138     129  
Immune system disorders          
Seasonal Allergy * 1        
# participants affected / at risk     0/76 (0.00%)     4/76 (5.26%)     0/76 (0.00%)     0/76 (0.00%)  
# events     0     4     0     0  
Infections and infestations          
Conjunctivitis Infective * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     4/76 (5.26%)     0/76 (0.00%)  
# events     0     0     5     0  
Ear Infection * 1        
# participants affected / at risk     5/76 (6.58%)     12/76 (15.79%)     8/76 (10.53%)     17/76 (22.37%)  
# events     6     17     8     25  
Influenza * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     4/76 (5.26%)     0/76 (0.00%)  
# events     0     0     4     0  
Nasopharyngitis * 1        
# participants affected / at risk     4/76 (5.26%)     0/76 (0.00%)     0/76 (0.00%)     4/76 (5.26%)  
# events     6     0     0     6  
Otitis Media * 1        
# participants affected / at risk     17/76 (22.37%)     7/76 (9.21%)     21/76 (27.63%)     15/76 (19.74%)  
# events     24     7     33     23  
Pharyngitis Streptococcal * 1        
# participants affected / at risk     7/76 (9.21%)     9/76 (11.84%)     6/76 (7.89%)     11/76 (14.47%)  
# events     10     11     9     16  
Rhinitis * 1        
# participants affected / at risk     7/76 (9.21%)     10/76 (13.16%)     10/76 (13.16%)     6/76 (7.89%)  
# events     10     12     11     11  
Sinusitis * 1        
# participants affected / at risk     13/76 (17.11%)     13/76 (17.11%)     11/76 (14.47%)     22/76 (28.95%)  
# events     20     15     16     25  
Upper Respiratory Tract Infection * 1        
# participants affected / at risk     0/76 (0.00%)     5/76 (6.58%)     0/76 (0.00%)     4/76 (5.26%)  
# events     0     6     0     4  
Injury, poisoning and procedural complications          
Arthropod Bite * 1        
# participants affected / at risk     5/76 (6.58%)     5/76 (6.58%)     0/76 (0.00%)     0/76 (0.00%)  
# events     5     5     0     0  
Contusion * 1        
# participants affected / at risk     5/76 (6.58%)     5/76 (6.58%)     4/76 (5.26%)     6/76 (7.89%)  
# events     5     8     5     8  
Excoriation * 1        
# participants affected / at risk     4/76 (5.26%)     4/76 (5.26%)     0/76 (0.00%)     0/76 (0.00%)  
# events     5     4     0     0  
Procedural Pain * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)     4/76 (5.26%)  
# events     0     0     0     4  
Skin Laceration * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)     7/76 (9.21%)  
# events     0     0     0     7  
Sunburn * 1        
# participants affected / at risk     0/76 (0.00%)     5/76 (6.58%)     0/76 (0.00%)     0/76 (0.00%)  
# events     0     6     0     0  
Investigations          
Alanine Aminotransferase Increased * 1        
# participants affected / at risk     0/76 (0.00%)     4/76 (5.26%)     0/76 (0.00%)     0/76 (0.00%)  
# events     0     4     0     0  
Aspartate Aminotransferase Increased * 1        
# participants affected / at risk     0/76 (0.00%)     4/76 (5.26%)     0/76 (0.00%)     0/76 (0.00%)  
# events     0     4     0     0  
Breath Sounds Abnormal * 1        
# participants affected / at risk     9/76 (11.84%)     10/76 (13.16%)     10/76 (13.16%)     8/76 (10.53%)  
# events     13     15     13     8  
Chest X-Ray Abnormal * 1        
# participants affected / at risk     8/76 (10.53%)     7/76 (9.21%)     9/76 (11.84%)     8/76 (10.53%)  
# events     8     9     9     9  
Forced Expiratory Volume Decreased * 1        
# participants affected / at risk     11/76 (14.47%)     12/76 (15.79%)     9/76 (11.84%)     9/76 (11.84%)  
# events     16     15     10     11  
Increased Anteroposterior Chest Diameter * 1        
# participants affected / at risk     4/76 (5.26%)     5/76 (6.58%)     4/76 (5.26%)     0/76 (0.00%)  
# events     4     5     5     0  
Methicillin-Resistant Staphylococcal Aureus Test Positive * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)     4/76 (5.26%)  
# events     0     0     0     4  
Pulmonary Function Test Decreased * 1        
# participants affected / at risk     4/76 (5.26%)     5/76 (6.58%)     5/76 (6.58%)     9/76 (11.84%)  
# events     5     6     5     14  
Respiratory Rate Increased * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)     4/76 (5.26%)  
# events     0     0     0     4  
Sputum Abnormal * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     4/76 (5.26%)     0/76 (0.00%)  
# events     0     0     4     0  
Weight Decreased * 1        
# participants affected / at risk     7/76 (9.21%)     10/76 (13.16%)     6/76 (7.89%)     14/76 (18.42%)  
# events     9     12     6     17  
White Blood Cell Count Increased * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)     5/76 (6.58%)  
# events     0     0     0     5  
Metabolism and nutrition disorders          
Decreased Appetite * 1        
# participants affected / at risk     17/76 (22.37%)     9/76 (11.84%)     9/76 (11.84%)     20/76 (26.32%)  
# events     27     10     9     30  
Musculoskeletal and connective tissue disorders          
Arthralgia * 1        
# participants affected / at risk     14/76 (18.42%)     14/76 (18.42%)     14/76 (18.42%)     12/76 (15.79%)  
# events     17     25     18     14  
Back Pain * 1        
# participants affected / at risk     0/76 (0.00%)     7/76 (9.21%)     0/76 (0.00%)     5/76 (6.58%)  
# events     0     8     0     7  
Clubbing * 1        
# participants affected / at risk     7/76 (9.21%)     15/76 (19.74%)     7/76 (9.21%)     8/76 (10.53%)  
# events     7     16     8     9  
Muscle Spasms * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     5/76 (6.58%)     0/76 (0.00%)  
# events     0     0     6     0  
Musculoskeletal Pain * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     4/76 (5.26%)     0/76 (0.00%)  
# events     0     0     7     0  
Myalgia * 1        
# participants affected / at risk     4/76 (5.26%)     0/76 (0.00%)     6/76 (7.89%)     0/76 (0.00%)  
# events     4     0     6     0  
Neck Pain * 1        
# participants affected / at risk     0/76 (0.00%)     8/76 (10.53%)     0/76 (0.00%)     0/76 (0.00%)  
# events     0     8     0     0  
Pain in Extremity * 1        
# participants affected / at risk     7/76 (9.21%)     15/76 (19.74%)     10/76 (13.16%)     12/76 (15.79%)  
# events     8     27     16     14  
Nervous system disorders          
Dizziness * 1        
# participants affected / at risk     0/76 (0.00%)     5/76 (6.58%)     6/76 (7.89%)     4/76 (5.26%)  
# events     0     7     6     7  
Headache * 1        
# participants affected / at risk     38/76 (50.00%)     28/76 (36.84%)     24/76 (31.58%)     31/76 (40.79%)  
# events     72     69     47     75  
Lethargy * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)     6/76 (7.89%)  
# events     0     0     0     7  
Psychiatric disorders          
Decreased Activity * 1        
# participants affected / at risk     10/76 (13.16%)     5/76 (6.58%)     5/76 (6.58%)     7/76 (9.21%)  
# events     11     5     5     7  
Renal and urinary disorders          
Dysuria * 1        
# participants affected / at risk     4/76 (5.26%)     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)  
# events     5     0     0     0  
Respiratory, thoracic and mediastinal disorders          
Asthma * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)     4/76 (5.26%)  
# events     0     0     0     4  
Atelectasis * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     5/76 (6.58%)     0/76 (0.00%)  
# events     0     0     5     0  
Bronchial Wall Thickening * 1        
# participants affected / at risk     5/76 (6.58%)     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)  
# events     5     0     0     0  
Cough * 1        
# participants affected / at risk     62/76 (81.58%)     63/76 (82.89%)     65/76 (85.53%)     71/76 (93.42%)  
# events     202     240     224     282  
Dysphonia * 1        
# participants affected / at risk     11/76 (14.47%)     16/76 (21.05%)     12/76 (15.79%)     15/76 (19.74%)  
# events     16     28     26     22  
Dyspnoea * 1        
# participants affected / at risk     5/76 (6.58%)     8/76 (10.53%)     13/76 (17.11%)     7/76 (9.21%)  
# events     6     9     19     9  
Epistaxis * 1        
# participants affected / at risk     8/76 (10.53%)     7/76 (9.21%)     12/76 (15.79%)     8/76 (10.53%)  
# events     9     8     20     11  
Nasal Congestion * 1        
# participants affected / at risk     44/76 (57.89%)     38/76 (50.00%)     40/76 (52.63%)     48/76 (63.16%)  
# events     88     68     85     98  
Nasal Discomfort * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     4/76 (5.26%)     0/76 (0.00%)  
# events     0     0     4     0  
Nasal Mucosal Disorder * 1        
# participants affected / at risk     6/76 (7.89%)     7/76 (9.21%)     10/76 (13.16%)     6/76 (7.89%)  
# events     8     9     12     6  
Nasal Oedema * 1        
# participants affected / at risk     8/76 (10.53%)     8/76 (10.53%)     9/76 (11.84%)     12/76 (15.79%)  
# events     10     9     11     13  
Nasal Polyps * 1        
# participants affected / at risk     4/76 (5.26%)     8/76 (10.53%)     9/76 (11.84%)     7/76 (9.21%)  
# events     4     9     10     7  
Oropharyngeal Pain * 1        
# participants affected / at risk     19/76 (25.00%)     26/76 (34.21%)     24/76 (31.58%)     28/76 (36.84%)  
# events     31     51     36     59  
Pharyngeal Erythema * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     4/76 (5.26%)     5/76 (6.58%)  
# events     0     0     4     5  
Postnasal Drip † 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     5/76 (6.58%)     0/76 (0.00%)  
# events     0     0     5     0  
Productive Cough * 1        
# participants affected / at risk     17/76 (22.37%)     23/76 (30.26%)     22/76 (28.95%)     28/76 (36.84%)  
# events     23     40     38     48  
Rales * 1        
# participants affected / at risk     10/76 (13.16%)     13/76 (17.11%)     11/76 (14.47%)     12/76 (15.79%)  
# events     11     19     16     16  
Respiratory Tract Congestion * 1        
# participants affected / at risk     7/76 (9.21%)     17/76 (22.37%)     13/76 (17.11%)     13/76 (17.11%)  
# events     8     32     15     18  
Rhinorrhoea * 1        
# participants affected / at risk     41/76 (53.95%)     48/76 (63.16%)     47/76 (61.84%)     50/76 (65.79%)  
# events     100     123     119     139  
Rhonchi * 1        
# participants affected / at risk     6/76 (7.89%)     0/76 (0.00%)     0/76 (0.00%)     4/76 (5.26%)  
# events     6     0     0     4  
Sinus Congestion * 1        
# participants affected / at risk     5/76 (6.58%)     6/76 (7.89%)     0/76 (0.00%)     5/76 (6.58%)  
# events     7     6     0     6  
Sneezing * 1        
# participants affected / at risk     5/76 (6.58%)     6/76 (7.89%)     0/76 (0.00%)     5/76 (6.58%)  
# events     7     6     0     6  
Sputum Discolored * 1        
# participants affected / at risk     0/76 (0.00%)     4/76 (5.26%)     4/76 (5.26%)     0/76 (0.00%)  
# events     0     8     4     0  
Tachypnoea * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)     4/76 (5.26%)  
# events     0     0     0     4  
Tonsillar Hypertrophy * 1        
# participants affected / at risk     9/76 (11.84%)     4/76 (5.26%)     7/76 (9.21%)     5/76 (6.58%)  
# events     9     4     7     6  
Wheezing * 1        
# participants affected / at risk     18/76 (23.68%)     15/76 (19.74%)     12/76 (15.79%)     17/76 (22.37%)  
# events     24     24     16     22  
Skin and subcutaneous tissue disorders          
Dermatitis Contact * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)     5/76 (6.58%)  
# events     0     0     0     5  
Dermatitis Diaper * 1        
# participants affected / at risk     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)     10/76 (13.16%)  
# events     0     0     0     18  
Erythema * 1        
# participants affected / at risk     4/76 (5.26%)     0/76 (0.00%)     4/76 (5.26%)     0/76 (0.00%)  
# events     4     0     7     0  
Rash * 1        
# participants affected / at risk     11/76 (14.47%)     13/76 (17.11%)     16/76 (21.05%)     16/76 (21.05%)  
# events     15     18     21     19  
Urticaria * 1        
# participants affected / at risk     4/76 (5.26%)     0/76 (0.00%)     0/76 (0.00%)     0/76 (0.00%)  
# events     5     0     0     0  
Surgical and medical procedures          
Sinus Operation * 1        
# participants affected / at risk     0/76 (0.00%)     7/76 (9.21%)     0/76 (0.00%)     0/76 (0.00%)  
# events     0     7     0     0  
Events were collected by systematic assessment
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedRRA



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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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