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| Name | Class |
|---|---|
| Immune Tolerance Network (ITN) | NETWORK |
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ITN049AD (LEAP-On) Study is a continuation of the ITN032AD LEAP Study (NCT00329784).
Peanut Allergy, a recognized public health concern, is a common and potentially life-threatening food allergy for which there is no treatment. ITN032AD (LEAP) Study evaluated whether early exposure to peanut promotes tolerance and provides protection from developing peanut allergy in children who are allergic to eggs or who have severe eczema. ITN049AD (LEAP-On) Study will evaluate persistent tolerance to peanut by assessing the effect of twelve months of cessation of peanut consumption in LEAP Study participants who consumed peanut and those who avoided peanut over the previous five years.
This is a two-sample comparison employing all available study participants in both arms of the LEAP (NCT00329784) study at visit 72. After obtaining informed consent, LEAP participants who are evaluable for peanut allergy at age 60 months (V60) will be enrolled into this study, the LEAP-On (NCT01366846) Study. All LEAP-On participants will avoid peanut for an additional 12 months regardless of their previous allocation to the LEAP Study consumption arm (Group A) or the LEAP Study avoidance arm (Group B).
At V72, after 12 months of this new intervention, all participants will have skin prick testing (SPT), specific IgE and a repeat oral challenge to peanut to determine the frequency of peanut allergy in both groups. The LEAP Study decision table will be used to determine the presence of peanut allergy. Briefly, peanut allergy will be based on the presence of a positive oral peanut challenge with objective signs of allergy. Tolerance will be established on the basis of a negative oral peanut challenge (tolerating 5 g of peanut protein in the absence of symptoms). For participants who do not have an oral challenge or an oral challenge at V72 with a determinate outcome, the following criteria will be used to determine their outcome at V72:
Predictive values of peanut-specific IgE and/or SPT will not be used in the LEAP-On study because participants in the peanut consumption arm in the LEAP study are tolerating peanuts despite having high IgE and/or SPT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peanut avoidance after continuous peanut consumption | Experimental | These participants were the peanut consumption group of the ITN032AD (LEAP) study |
|
| Continued peanut avoidance | Experimental | These participants were the peanut avoidance group of the ITN032AD (LEAP) study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avoidance of peanut | Other | All participants will be assigned to peanut avoidance as per United Kingdom (UK) public health recommendations and will avoid exposure to peanut protein during the study until the last study visit when they will receive the Oral Food Challenge. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum | At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to not have peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA. | 72 months |
| Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group | At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA. | 72 months |
| Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum in the Per Protocol Population | At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within the Peanut Avoidance After Peanut Consumption Group | At 60 and 72 months of age, eligible participants were given an oral food challenge (intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 9.4g/13.7g (month 60/month 72) of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gideon Lack, MD | Evelina Children's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evelina Children's Hospital | London | SE1 7EH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25705822 | Background | Du Toit G, Roberts G, Sayre PH, Bahnson HT, Radulovic S, Santos AF, Brough HA, Phippard D, Basting M, Feeney M, Turcanu V, Sever ML, Gomez Lorenzo M, Plaut M, Lack G; LEAP Study Team. Randomized trial of peanut consumption in infants at risk for peanut allergy. N Engl J Med. 2015 Feb 26;372(9):803-13. doi: 10.1056/NEJMoa1414850. Epub 2015 Feb 23. | |
| 25956314 |
| Label | URL |
|---|---|
| LEAP Study informational website | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| LEAP-On (ITN049AD) | Individual Participant Data Set | View IPD |
ITN049AD (LEAP-On) is a continuation of the ITN032AD LEAP Study. The plan is to share data in: 1.) ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts; and 2.)TrialShare, a clinical trials research portal developed by the Immune Tolerance Network.
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In the LEAP trial, participants were stratified into strata based on a peanut allergen skin prick test (SPT). Participants were either SPT negative (0mm wheal) or SPT positive (1-4 mm wheal). Participants were then randomized into treatment groups within each stratum. This configuration was preserved in LEAP-On (this trial)
From among those who completed the LEAP study (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), 556 subjects were recruited between 26 May 2011 and 6 June 2014 at Evelina Children's Hospital in London, UK.
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| ID | Title | Description |
|---|---|---|
| FG000 | Negative Stratum - Continued Peanut Avoidance Group | Participants who had a negative response to a peanut allergen skin prick test (no measurable wheal) and were then randomized into the peanut avoidance group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial) |
| FG001 | Negative Stratum - Peanut Avoidance After Consumption Group | Participants who had a negative response to a peanut allergen skin prick test (no measurable wheal) and were then randomized into the peanut consumption group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial). |
| FG002 | Positive Stratum - Continued Peanut Avoidance Group | Participants who had a positive response to a peanut allergen skin prick test (a wheal measuring between 1 and 4 mm) and were then randomized into the peanut avoidance group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial). |
| FG003 | Positive Stratum - Peanut Avoidance After Peanut Consumption G | Participants who had a positive response to a peanut allergen skin prick test (a wheal measuring between 1 and 4 mm) and were then randomized into the peanut consumption group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat
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| ID | Title | Description |
|---|---|---|
| BG000 | Negative Stratum - Peanut Avoidance Group | Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum | At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to not have peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA. | Intent-to-treat with available data at 72 months | Posted | Count of Participants | Participants | 72 months |
|
4 years, 3 months
During active follow-up study ITN049AD
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Negative Stratum - Peanut Avoidance Group | Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic reaction | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Operations Program | DAIT/NIAID | 301-594-7669 | DAITClinicalTrialsGov@niaid.nih.gov |
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| ID | Term |
|---|---|
| D004485 | Eczema |
| D021181 | Egg Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| 72 months |
| Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group in the Per Protocol Population | At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA. | 72 months |
| 60 months and 72 months |
| Number of Peanut Avoidance After Peanut Consumption Group Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within in the Per Protocol Population | At 60 and 72 months of age, eligible participants were given an oral food challenge (intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 9.4g/13.7g (month 60/month 72) of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA. | 60 months and 72 months |
| Santos AF, Du Toit G, Lack G. Is the use of epinephrine a good marker of severity of allergic reactions during oral food challenges? J Allergy Clin Immunol Pract. 2015 May-Jun;3(3):429-30. doi: 10.1016/j.jaip.2014.12.009. No abstract available. |
| 25705823 | Background | Gruchalla RS, Sampson HA. Preventing peanut allergy through early consumption--ready for prime time? N Engl J Med. 2015 Feb 26;372(9):875-7. doi: 10.1056/NEJMe1500186. Epub 2015 Feb 23. No abstract available. |
| 26942922 | Result | Du Toit G, Sayre PH, Roberts G, Sever ML, Lawson K, Bahnson HT, Brough HA, Santos AF, Harris KM, Radulovic S, Basting M, Turcanu V, Plaut M, Lack G; Immune Tolerance Network LEAP-On Study Team. Effect of Avoidance on Peanut Allergy after Early Peanut Consumption. N Engl J Med. 2016 Apr 14;374(15):1435-43. doi: 10.1056/NEJMoa1514209. Epub 2016 Mar 4. |
| Immune Tolerance Network website | View source |
| National Institute of Allergy and Infectious Diseases (NIAID) website | View source |
| LEAP-On (ITN049AD) | Study protocol synopsis; datasets and figures from published NEJM 2016 article | View IPD |
| Communication Difficulties |
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| Scheduling Conflicts |
|
| Negative Stratum - Peanut Consumption Group |
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. |
| BG002 | Positive Stratum - Peanut Avoidance Group | Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation. |
| BG003 | Positive Stratum - Peanut Consumption Group | Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. |
| BG004 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Negative Stratum - Peanut Avoidance Group |
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation. |
| OG001 | Negative Stratum - Peanut Consumption Group | Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. |
| OG002 | Positive Stratum - Peanut Avoidance Group | Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation. |
| OG003 | Positive Stratum - Peanut Consumption Group | Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. |
|
|
|
| Primary | Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group | At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA. | Intent-to-treat with available data at 72 Months | Posted | Count of Participants | Participants | 72 months |
|
|
|
|
| Primary | Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum in the Per Protocol Population | At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy. | Per Protocol | Posted | Count of Participants | Participants | 72 months |
|
|
|
|
| Primary | Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group in the Per Protocol Population | At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA. | Per Protocol | Posted | Count of Participants | Participants | 72 months |
|
|
|
|
| Secondary | Number of Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within the Peanut Avoidance After Peanut Consumption Group | At 60 and 72 months of age, eligible participants were given an oral food challenge (intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 9.4g/13.7g (month 60/month 72) of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA. | Intent-to-treat | Posted | Count of Participants | Participants | 60 months and 72 months |
|
|
|
|
| Secondary | Number of Peanut Avoidance After Peanut Consumption Group Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within in the Per Protocol Population | At 60 and 72 months of age, eligible participants were given an oral food challenge (intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 9.4g/13.7g (month 60/month 72) of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA. | Per Protocol | Posted | Count of Participants | Participants | 60 months and 72 months |
|
|
|
|
| 12 |
| 235 |
| 206 |
| 235 |
| EG001 | Negative Stratum - Peanut Consumption Group | Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. | 7 | 228 | 182 | 228 |
| EG002 | Positive Stratum - Peanut Avoidance Group | Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation. | 3 | 47 | 45 | 47 |
| EG003 | Positive Stratum - Peanut Consumption Group | Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. | 2 | 46 | 38 | 46 |
| Abscess limb | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Eczema infected | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
Not provided
Not provided
| D006969 |
| Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| Chi-squared |
| 0.027 |
| Superiority or Other |