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| ID | Type | Description | Link |
|---|---|---|---|
| B1851044 |
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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
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The purpose of the study is to expand the understanding of the safety profile of 13vPnC in routine use following licensure and introduction of the vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window).Relative risk in inpatient health care setting for pre-dose 1 assessed by comparing incidence rate of reported events in inpatient setting/1000 person-months occurring within 30 days after Dose 1(30-day risk window) with self-control period occurring during 30 days before Dose 1(pre-vaccination 30-day self-control window).Relative risk,exact 2-sided 90 percent (%) confidence intervals (CIs) reported. Medically attended events documented retrospectively according to International Classification of Diseases, ninth Revision (ICD-9) coding.Medical attended event acute bronchiolitis due to Respiratory Syncytial Virus (RSV) has been represented as acute bronchiolitis due to RSV and acute pyelonephritis without renal medullary necrosis(RMN) lesion has been represented as acute pyelonephritis without RMN lesion in measure categories below.Results reported for events reported in either of the windows. | 30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1) |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for pre-dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | 30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1) |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined |
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Inclusion Criteria:
Exclusion Criteria:
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60,000 infants total: at least 43,000 infants who receive all 3 primary series doses of 13vPnC plus 15,000 additional infants who receive less than 3 doses of 13vPnC
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern California Kaiser Permanente | Oakland | California | 94612 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 13vPnC | Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.
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| ID | Title | Description |
|---|---|---|
| BG000 | 13vPnC | Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3. |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient | Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window).Relative risk in inpatient health care setting for pre-dose 1 assessed by comparing incidence rate of reported events in inpatient setting/1000 person-months occurring within 30 days after Dose 1(30-day risk window) with self-control period occurring during 30 days before Dose 1(pre-vaccination 30-day self-control window).Relative risk,exact 2-sided 90 percent (%) confidence intervals (CIs) reported. Medically attended events documented retrospectively according to International Classification of Diseases, ninth Revision (ICD-9) coding.Medical attended event acute bronchiolitis due to Respiratory Syncytial Virus (RSV) has been represented as acute bronchiolitis due to RSV and acute pyelonephritis without renal medullary necrosis(RMN) lesion has been represented as acute pyelonephritis without RMN lesion in measure categories below.Results reported for events reported in either of the windows. | Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period. | Posted | Number | 90% Confidence Interval | ratio | 30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1) |
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Adverse events (AEs) and serious adverse events (SAEs) were not planned to be collected as this was a non-interventional, observational study, consisting of secondary analysis of de-identified electronic health care database and coded data which did not meet the criteria for reportable AEs.
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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 | 13vPnC | Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for pre-dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. |
| 30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1) |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% (CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1) |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1) |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1) |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2) |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2) |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 2 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows. | 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2) |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3) |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and its corresponding exact 2-sided 90% confidence CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3) |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window). Relative risk in inpatient and emergency department health care setting for Dose 3 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows. | 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3) |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in inpatient health care setting for primary series was assessed by comparing the combined incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | 30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series) |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | 30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series) |
| Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in in inpatient and emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in both the settings per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | 30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series) |
| days |
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| Sex: Female, Male | Count of Participants | Participants |
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| Primary | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for pre-dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period. | Posted | Number | 90% Confidence Interval | ratio | 30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1) |
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| Primary | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for pre-dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period. | Posted | Number | 90% Confidence Interval | ratio | 30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1) |
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| Primary | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% (CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period. | Posted | Number | 90% Confidence Interval | ratio | 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1) |
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| Primary | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period. | Posted | Number | 90% Confidence Interval | ratio | 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1) |
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| Primary | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period. | Posted | Number | 90% Confidence Interval | ratio | 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1) |
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| Primary | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period. | Posted | Number | 90% Confidence Interval | ratio | 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2) |
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| Primary | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period. | Posted | Number | 90% Confidence Interval | ratio | 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2) |
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| Primary | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 2 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows. | Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period. | Posted | Number | 90% Confidence Interval | ratio | 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2) |
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| Primary | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period. | Posted | Number | 90% Confidence Interval | ratio | 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3) |
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| Primary | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and its corresponding exact 2-sided 90% confidence CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period. | Posted | Number | 90% Confidence Interval | ratio | 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3) |
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| Primary | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined | Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window). Relative risk in inpatient and emergency department health care setting for Dose 3 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows. | Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period. | Posted | Number | 90% Confidence Interval | ratio | 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3) |
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| Primary | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in inpatient health care setting for primary series was assessed by comparing the combined incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period. | Posted | Number | 90% Confidence Interval | ratio | 30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series) |
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|
|
|
| Primary | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period. | Posted | Number | 90% Confidence Interval | ratio | 30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series) |
|
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|
|
| Primary | Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined | Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in in inpatient and emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in both the settings per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows. | Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period. | Posted | Number | 90% Confidence Interval | ratio | 30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series) |
|
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|
|
| 0 |
| 0 |
| 0 |
| 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D007239 | Infections |
|
| Acute pyelonephritis without RMN lesion |
|
| Adverse drug reaction |
|
| Alkalosis |
|
| Apnea |
|
| Apparent life threatening event infant |
|
| Asthma with acute exacerbation |
|
| Asthma, unspecified, unspecified status |
|
| Bronchiolitis |
|
| Bronchitis |
|
| Bronchospasm |
|
| Candidiasis of mouth |
|
| Constipation |
|
| Croup |
|
| Dehydration |
|
| Dermatitis |
|
| Dyspnea |
|
| Failure to thrive |
|
| Fever |
|
| Fussy infant |
|
| Gastroenteritis |
|
| Hematoma |
|
| Methicillin susceptible Staphylococcus aureus |
|
| Nausea and vomiting |
|
| Neonatal candida infection |
|
| Other diseases of nasal cavity and sinuses |
|
| Other specified cardiac dysrhythmias |
|
| Pneumonia |
|
| Primary apnea of newborn |
|
| Rash |
|
| Respiratory syncytial virus |
|
| Single seizure |
|
| Stomatitis |
|
| Stridor |
|
| Subconjunctival hemorrhage |
|
| Umbilical hernia without obstruction/gangrene |
|
| Unspecified septicemia |
|
| Urinary tract infection |
|
| Urticaria |
|
| Vaccines adverse reaction |
|
| Viral syndrome |
|
| Weakness |
|
| Wheezing |
|
| mid-p exact binomial method |
| <0.01 |
| No |
| Superiority or Other |
| Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.04 | No | Superiority or Other |
| Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.99 | No | Superiority or Other |
| Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.61 | No | Superiority or Other |
| Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.42 | No | Superiority or Other |
| Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.71 | No | Superiority or Other |
| Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.36 | No | Superiority or Other |
| Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.37 | No | Superiority or Other |
| Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.19 | No | Superiority or Other |
| Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.77 | No | Superiority or Other |
| Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.07 | No | Superiority or Other |
| Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.41 | No | Superiority or Other |
| Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.63 | No | Superiority or Other |
| Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.04 | No | Superiority or Other |
| Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.75 | No | Superiority or Other |
| Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.99 | No | Superiority or Other |
| Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.01 | No | Superiority or Other |
| Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.12 | No | Superiority or Other |
| Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.83 | No | Superiority or Other |
| Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.12 | No | Superiority or Other |
| Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.26 | No | Superiority or Other |
| Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.83 | No | Superiority or Other |
| Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.98 | No | Superiority or Other |
| Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.06 | No | Superiority or Other |
| Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.63 | No | Superiority or Other |
| Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.74 | No | Superiority or Other |
| Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.66 | No | Superiority or Other |
| Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.13 | No | Superiority or Other |
| Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.13 | No | Superiority or Other |
| Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.53 | No | Superiority or Other |
| Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.62 | No | Superiority or Other |
| Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.77 | No | Superiority or Other |
|
| Acute otitis media |
|
| Acute pyelonephritis without RMN lesion |
|
| Adverse drug reaction |
|
| Alkalosis |
|
| Apnea |
|
| Apparent life threatening event infant |
|
| Asthma with acute exacerbation |
|
| Asthma, unspecified, unspecified status |
|
| Bronchiolitis |
|
| Bronchitis |
|
| Bronchospasm |
|
| Candidiasis of mouth |
|
| Cellulitis and abscess of trunk |
|
| Constipation |
|
| Croup |
|
| Dehydration |
|
| Dermatitis |
|
| Dyspnea |
|
| Failure to thrive |
|
| Fever |
|
| Fussy infant |
|
| Gastroenteritis |
|
| Hematoma |
|
| Hypopotassemia |
|
| Lipoma of other specified sites |
|
| Methicillin susceptible Staphylococcus aureus |
|
| Nausea and vomiting |
|
| Neonatal bradycardia |
|
| Neonatal candida infection |
|
| Other diseases of nasal cavity and sinuses |
|
| Other specified cardiac dysrhythmias |
|
| Pilonidal cyst without mention of abscess |
|
| Pneumonia |
|
| Primary apnea of newborn |
|
| Rash |
|
| Respiratory syncytial virus |
|
| Retinopathy of prematurity stage 2 |
|
| Single seizure |
|
| Stomatitis |
|
| Stridor |
|
| Subconjunctival hemorrhage |
|
| Umbilical hernia without obstruction/gangrene |
|
| Unspecified bacterial pneumonia |
|
| Unspecified septicemia |
|
| Urinary tract infection |
|
| Urticaria |
|
| Vaccines adverse reaction |
|
| Viral syndrome |
|
| Weakness |
|
| Wheezing |
|
| mid-p exact binomial method |
| <0.01 |
| No |
| Superiority or Other |
| Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.99 | No | Superiority or Other |
| Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.63 | No | Superiority or Other |
| Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.20 | No | Superiority or Other |
| Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.99 | No | Superiority or Other |
| Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.79 | No | Superiority or Other |
| Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.09 | No | Superiority or Other |
| Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.03 | No | Superiority or Other |
| Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.40 | No | Superiority or Other |
| Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.07 | No | Superiority or Other |
| Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.67 | No | Superiority or Other |
| Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.36 | No | Superiority or Other |
| Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.98 | No | Superiority or Other |
| Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.03 | No | Superiority or Other |
| Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.04 | No | Superiority or Other |
| Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.33 | No | Superiority or Other |
| Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.71 | No | Superiority or Other |
| Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.02 | No | Superiority or Other |
| Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.13 | No | Superiority or Other |
| Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.99 | No | Superiority or Other |
| Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.67 | No | Superiority or Other |
| Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.77 | No | Superiority or Other |
| Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.61 | No | Superiority or Other |
| Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.33 | No | Superiority or Other |
| Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.05 | No | Superiority or Other |
| Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.38 | No | Superiority or Other |
| Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.71 | No | Superiority or Other |
| Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.97 | No | Superiority or Other |
| Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.26 | No | Superiority or Other |
| Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.63 | No | Superiority or Other |
| Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.23 | No | Superiority or Other |
| Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.85 | No | Superiority or Other |
| Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.02 | No | Superiority or Other |
| Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.13 | No | Superiority or Other |
| Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.13 | No | Superiority or Other |
| Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.09 | No | Superiority or Other |
| Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.99 | No | Superiority or Other |
| Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.77 | No | Superiority or Other |
| Acute febrile mucocutaneous lymph node syndrome |
|
| Acute otitis media |
|
| Acute pyelonephritis without RMN lesion |
|
| Alkalosis |
|
| Apnea |
|
| Apparent life threatening event infant |
|
| Asthma, unspecified, unspecified status |
|
| Bronchiolitis |
|
| Bronchitis |
|
| Candidiasis of mouth |
|
| Cellulitis and abscess of trunk |
|
| Constipation |
|
| Croup |
|
| Dehydration |
|
| Dermatitis |
|
| Dyspnea |
|
| Failure to thrive |
|
| Fever |
|
| Fussy infant |
|
| Gastroenteritis |
|
| Hypopotassemia |
|
| Lipoma of other specified sites |
|
| Methicillin susceptible Staphylococcus aureus |
|
| Nausea and vomiting |
|
| Neonatal bradycardia |
|
| Other diseases of nasal cavity and sinuses |
|
| Other specified cardiac dysrhythmias |
|
| Pilonidal cyst without mention of abscess |
|
| Pneumonia |
|
| Primary apnea of newborn |
|
| Rash |
|
| Respiratory syncytial virus |
|
| Retinopathy of prematurity stage 2 |
|
| Single seizure |
|
| Stridor |
|
| Umbilical hernia without obstruction/gangrene |
|
| Unspecified bacterial pneumonia |
|
| Unspecified septicemia |
|
| Urinary tract infection |
|
| Viral syndrome |
|
| Weakness |
|
| mid-p exact binomial method |
| <0.01 |
| No |
| Superiority or Other |
| Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.95 | No | Superiority or Other |
| Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.91 | No | Superiority or Other |
| Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.86 | No | Superiority or Other |
| Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.02 | No | Superiority or Other |
| Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.13 | No | Superiority or Other |
| Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.11 | No | Superiority or Other |
| Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.04 | No | Superiority or Other |
| Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.05 | No | Superiority or Other |
| Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.42 | No | Superiority or Other |
| Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.33 | No | Superiority or Other |
| Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.88 | No | Superiority or Other |
| Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.79 | No | Superiority or Other |
| Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.57 | No | Superiority or Other |
| Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.24 | No | Superiority or Other |
| Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
| Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.42 | No | Superiority or Other |
| Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.23 | No | Superiority or Other |
| Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.57 | No | Superiority or Other |
| Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.15 | No | Superiority or Other |
| Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.08 | No | Superiority or Other |
| Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.46 | No | Superiority or Other |
| Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.88 | No | Superiority or Other |
| Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.04 | No | Superiority or Other |
| Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.93 | No | Superiority or Other |
| Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.95 | No | Superiority or Other |
| Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.38 | No | Superiority or Other |
| Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.90 | No | Superiority or Other |
| Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.11 | No | Superiority or Other |
| Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.08 | No | Superiority or Other |
| Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.09 | No | Superiority or Other |
| Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.34 | No | Superiority or Other |
| Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.92 | No | Superiority or Other |
| Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
|
| Adverse drug reaction |
|
| Alkalosis |
|
| Apnea |
|
| Apparent life threatening event infant |
|
| Asthma with acute exacerbation |
|
| Asthma, unspecified, unspecified status |
|
| Bronchiolitis |
|
| Bronchitis |
|
| Bronchospasm |
|
| Candidiasis of mouth |
|
| Constipation |
|
| Croup |
|
| Dehydration |
|
| Dermatitis |
|
| Dyspnea |
|
| Failure to thrive |
|
| Fever |
|
| Fussy infant |
|
| Gastroenteritis |
|
| Hand, foot and mouth disease |
|
| Hematoma |
|
| Nausea and vomiting |
|
| Neonatal candida infection |
|
| Other diseases of nasal cavity and sinuses |
|
| Other specified cardiac dysrhythmias |
|
| Pneumonia |
|
| Rash |
|
| Respiratory syncytial virus |
|
| Single seizure |
|
| Stridor |
|
| Subconjunctival hemorrhage |
|
| Umbilical hernia without obstruction/gangrene |
|
| Unspecified septicemia |
|
| Urinary tract infection |
|
| Urticaria |
|
| Vaccines adverse reaction |
|
| Viral syndrome |
|
| Weakness |
|
| Wheezing |
|
| mid-p exact binomial method |
| 0.49 |
| No |
| Superiority or Other |
| Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.15 | No | Superiority or Other |
| Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.11 | No | Superiority or Other |
| Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.01 | No | Superiority or Other |
| Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.05 | No | Superiority or Other |
| Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.95 | No | Superiority or Other |
| Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.35 | No | Superiority or Other |
| Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.68 | No | Superiority or Other |
| Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.51 | No | Superiority or Other |
| Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.35 | No | Superiority or Other |
| Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.01 | No | Superiority or Other |
| Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.30 | No | Superiority or Other |
| Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.02 | No | Superiority or Other |
| Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.45 | No | Superiority or Other |
| Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.66 | No | Superiority or Other |
| Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.95 | No | Superiority or Other |
| Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.17 | No | Superiority or Other |
| Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.68 | No | Superiority or Other |
| Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.23 | No | Superiority or Other |
| Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.12 | No | Superiority or Other |
| Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.92 | No | Superiority or Other |
| Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.09 | No | Superiority or Other |
| Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.87 | No | Superiority or Other |
| Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.68 | No | Superiority or Other |
| Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.91 | No | Superiority or Other |
| Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.03 | No | Superiority or Other |
| Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
|
| Acute otitis media |
|
| Acute pyelonephritis without RMN lesion |
|
| Adverse drug reaction |
|
| Alkalosis |
|
| Apnea |
|
| Apparent life threatening event infant |
|
| Asthma with acute exacerbation |
|
| Asthma, unspecified, unspecified status |
|
| Bronchiolitis |
|
| Bronchitis |
|
| Bronchospasm |
|
| Candidiasis of mouth |
|
| Cellulitis and abscess of trunk |
|
| Constipation |
|
| Croup |
|
| Dehydration |
|
| Dermatitis |
|
| Dyspnea |
|
| Failure to thrive |
|
| Fever |
|
| Fussy infant |
|
| Gastroenteritis |
|
| Hand, foot and mouth disease |
|
| Hematoma |
|
| Hypopotassemia |
|
| Lipoma of other specified sites |
|
| Methicillin susceptible Staphylococcus aureus |
|
| Nausea and vomiting |
|
| Neonatal bradycardia |
|
| Neonatal candida infection |
|
| Other diseases of nasal cavity and sinuses |
|
| Other specified cardiac dysrhythmias |
|
| Pilonidal cyst without mention of abscess |
|
| Pneumonia |
|
| Primary apnea of newborn |
|
| Rash |
|
| Respiratory syncytial virus |
|
| Retinopathy of prematurity stage 2 |
|
| Single seizure |
|
| Stridor |
|
| Subconjunctival hemorrhage |
|
| Umbilical hernia without obstruction/gangrene |
|
| Unspecified bacterial pneumonia |
|
| Unspecified septicemia |
|
| Urinary tract infection |
|
| Urticaria |
|
| Vaccines adverse reaction |
|
| Viral syndrome |
|
| Weakness |
|
| Wheezing |
|
| mid-p exact binomial method |
| 0.02 |
| No |
| Superiority or Other |
| Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.95 | No | Superiority or Other |
| Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.28 | No | Superiority or Other |
| Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.86 | No | Superiority or Other |
| Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.02 | No | Superiority or Other |
| Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.10 | No | Superiority or Other |
| Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.06 | No | Superiority or Other |
| Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.19 | No | Superiority or Other |
| Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.18 | No | Superiority or Other |
| Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.68 | No | Superiority or Other |
| Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.35 | No | Superiority or Other |
| Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.05 | No | Superiority or Other |
| Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.42 | No | Superiority or Other |
| Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.29 | No | Superiority or Other |
| Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.11 | No | Superiority or Other |
| Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 1.00 | No | Superiority or Other |
| Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.16 | No | Superiority or Other |
| Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.19 | No | Superiority or Other |
| Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.40 | No | Superiority or Other |
| Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.33 | No | Superiority or Other |
| Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.95 | No | Superiority or Other |
| Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.57 | No | Superiority or Other |
| Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.15 | No | Superiority or Other |
| Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.08 | No | Superiority or Other |
| Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.68 | No | Superiority or Other |
| Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.15 | No | Superiority or Other |
| Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.06 | No | Superiority or Other |
| Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.04 | No | Superiority or Other |
| Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.96 | No | Superiority or Other |
| Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.13 | No | Superiority or Other |
| Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.67 | No | Superiority or Other |
| Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.65 | No | Superiority or Other |
| Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.10 | No | Superiority or Other |
| Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.08 | No | Superiority or Other |
| Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.08 | No | Superiority or Other |
| Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.91 | No | Superiority or Other |
| Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.05 | No | Superiority or Other |
| Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
|
| Acute otitis media |
|
| Acute pyelonephritis without RMN lesion |
|
| Alkalosis |
|
| Apnea |
|
| Apparent life threatening event infant |
|
| Asthma with acute exacerbation |
|
| Asthma, unspecified, unspecified status |
|
| Bronchiolitis |
|
| Bronchitis |
|
| Bronchospasm |
|
| Cellulitis and abscess of trunk |
|
| Constipation |
|
| Croup |
|
| Dehydration |
|
| Dermatitis |
|
| Dyspnea |
|
| Failure to thrive |
|
| Fever |
|
| Fussy infant |
|
| Gastroenteritis |
|
| Hypopotassemia |
|
| Lipoma of other specified sites |
|
| Methicillin susceptible Staphylococcus aureus |
|
| Nausea and vomiting |
|
| Other diseases of nasal cavity and sinuses |
|
| Other specified cardiac dysrhythmias |
|
| Pilonidal cyst without mention of abscess |
|
| Pneumonia |
|
| Primary apnea of newborn |
|
| Rash |
|
| Retinopathy of prematurity stage 2 |
|
| Single seizure |
|
| Stridor |
|
| Umbilical hernia without obstruction/gangrene |
|
| Unspecified bacterial pneumonia |
|
| Unspecified septicemia |
|
| Urinary tract infection |
|
| Urticaria |
|
| Viral syndrome |
|
| Weakness |
|
| mid-p exact binomial method |
| 0.87 |
| No |
| Superiority or Other |
| Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.96 | No | Superiority or Other |
| Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.33 | No | Superiority or Other |
| Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.23 | No | Superiority or Other |
| Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.19 | No | Superiority or Other |
| Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.96 | No | Superiority or Other |
| Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.66 | No | Superiority or Other |
| Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.28 | No | Superiority or Other |
| Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.96 | No | Superiority or Other |
| Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.96 | No | Superiority or Other |
| Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.41 | No | Superiority or Other |
| Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.80 | No | Superiority or Other |
| Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.98 | No | Superiority or Other |
| Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.51 | No | Superiority or Other |
| Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.92 | No | Superiority or Other |
| Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.76 | No | Superiority or Other |
| Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.91 | No | Superiority or Other |
| Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.23 | No | Superiority or Other |
| Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.95 | No | Superiority or Other |
| Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.34 | No | Superiority or Other |
| Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.41 | No | Superiority or Other |
| Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.07 | No | Superiority or Other |
| Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.69 | No | Superiority or Other |
| Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.40 | No | Superiority or Other |
| Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
| Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
| Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.96 | No | Superiority or Other |
| Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.96 | No | Superiority or Other |
| Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.80 | No | Superiority or Other |
| Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Acute otitis media |
|
| Adverse drug reaction |
|
| Apnea |
|
| Apparent life threatening event infant |
|
| Asthma with acute exacerbation |
|
| Asthma, unspecified, unspecified status |
|
| Bronchiolitis |
|
| Bronchitis |
|
| Bronchospasm |
|
| Candidiasis of mouth |
|
| Constipation |
|
| Croup |
|
| Dehydration |
|
| Dermatitis |
|
| Dyspnea |
|
| Failure to thrive |
|
| Fever |
|
| Fussy infant |
|
| Gastroenteritis |
|
| Hand, foot and mouth disease |
|
| Hematoma |
|
| Nausea and vomiting |
|
| Neonatal candida infection |
|
| Other diseases of nasal cavity and sinuses |
|
| Pneumonia |
|
| Rash |
|
| Respiratory syncytial virus |
|
| Single seizure |
|
| Stomatitis |
|
| Stridor |
|
| Subconjunctival hemorrhage |
|
| Umbilical hernia without obstruction/gangrene |
|
| Unspecified septicemia |
|
| Urinary tract infection |
|
| Urticaria |
|
| Vaccines adverse reaction |
|
| Viral syndrome |
|
| Weakness |
|
| Wheezing |
|
| mid-p exact binomial method |
| 0.04 |
| No |
| Superiority or Other |
| Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.01 | No | Superiority or Other |
| Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.95 | No | Superiority or Other |
| Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.23 | No | Superiority or Other |
| Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.34 | No | Superiority or Other |
| Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.87 | No | Superiority or Other |
| Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.35 | No | Superiority or Other |
| Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.84 | No | Superiority or Other |
| Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.64 | No | Superiority or Other |
| Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.95 | No | Superiority or Other |
| Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.41 | No | Superiority or Other |
| Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.51 | No | Superiority or Other |
| Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.95 | No | Superiority or Other |
| Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.13 | No | Superiority or Other |
| Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.70 | No | Superiority or Other |
| Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
| Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.33 | No | Superiority or Other |
| Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.90 | No | Superiority or Other |
| Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.67 | No | Superiority or Other |
| Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.07 | No | Superiority or Other |
| Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.38 | No | Superiority or Other |
| Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.34 | No | Superiority or Other |
| Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.54 | No | Superiority or Other |
| Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.57 | No | Superiority or Other |
| Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.70 | No | Superiority or Other |
| Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.03 | No | Superiority or Other |
| Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
|
| Acute otitis media |
|
| Acute pyelonephritis without RMN lesion |
|
| Adverse drug reaction |
|
| Alkalosis |
|
| Apnea |
|
| Apparent life threatening event infant |
|
| Asthma with acute exacerbation |
|
| Asthma, unspecified, unspecified status |
|
| Bronchiolitis |
|
| Bronchitis |
|
| Bronchospasm |
|
| Candidiasis of mouth |
|
| Cellulitis and abscess of trunk |
|
| Constipation |
|
| Croup |
|
| Dehydration |
|
| Dermatitis |
|
| Dyspnea |
|
| Failure to thrive |
|
| Fever |
|
| Fussy infant |
|
| Gastroenteritis |
|
| Hand, foot and mouth disease |
|
| Hematoma |
|
| Hypopotassemia |
|
| Lipoma of other specified sites |
|
| Methicillin susceptible Staphylococcus aureus |
|
| Nausea and vomiting |
|
| Neonatal candida infection |
|
| Other diseases of nasal cavity and sinuses |
|
| Other specified cardiac dysrhythmias |
|
| Pilonidal cyst without mention of abscess |
|
| Pneumonia |
|
| Primary apnea of newborn |
|
| Rash |
|
| Respiratory syncytial virus |
|
| Retinopathy of prematurity stage 2 |
|
| Single seizure |
|
| Stomatitis |
|
| Stridor |
|
| Subconjunctival hemorrhage |
|
| Umbilical hernia without obstruction/gangrene |
|
| Unspecified bacterial pneumonia |
|
| Unspecified septicemia |
|
| Urinary tract infection |
|
| Urticaria |
|
| Vaccines adverse reaction |
|
| Viral syndrome |
|
| Weakness |
|
| Wheezing |
|
| mid-p exact binomial method |
| 0.22 |
| No |
| Superiority or Other |
| Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.96 | No | Superiority or Other |
| Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.95 | No | Superiority or Other |
| Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.05 | No | Superiority or Other |
| Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.15 | No | Superiority or Other |
| Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.58 | No | Superiority or Other |
| Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.57 | No | Superiority or Other |
| Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.39 | No | Superiority or Other |
| Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.87 | No | Superiority or Other |
| Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.51 | No | Superiority or Other |
| Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.95 | No | Superiority or Other |
| Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.96 | No | Superiority or Other |
| Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.71 | No | Superiority or Other |
| Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.51 | No | Superiority or Other |
| Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.32 | No | Superiority or Other |
| Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.71 | No | Superiority or Other |
| Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.76 | No | Superiority or Other |
| Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.29 | No | Superiority or Other |
| Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.58 | No | Superiority or Other |
| Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.92 | No | Superiority or Other |
| Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.67 | No | Superiority or Other |
| Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.07 | No | Superiority or Other |
| Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.04 | No | Superiority or Other |
| Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.41 | No | Superiority or Other |
| Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.07 | No | Superiority or Other |
| Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.35 | No | Superiority or Other |
| Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.30 | No | Superiority or Other |
| Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.34 | No | Superiority or Other |
| Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.70 | No | Superiority or Other |
| Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
| Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.15 | No | Superiority or Other |
| Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.96 | No | Superiority or Other |
| Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.96 | No | Superiority or Other |
| Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.76 | No | Superiority or Other |
| Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.54 | No | Superiority or Other |
| Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.03 | No | Superiority or Other |
| Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
|
| Acute otitis media |
|
| Acute pyelonephritis without RMN lesion |
|
| Alkalosis |
|
| Apnea |
|
| Apparent life threatening event infant |
|
| Asthma with acute exacerbation |
|
| Asthma, unspecified, unspecified status |
|
| Bronchiolitis |
|
| Bronchitis |
|
| Candidiasis of mouth |
|
| Cellulitis and abscess of trunk |
|
| Constipation |
|
| Croup |
|
| Dehydration |
|
| Dermatitis |
|
| Dyspnea |
|
| Failure to thrive |
|
| Fever |
|
| Fussy infant |
|
| Gastroenteritis |
|
| Hand, foot and mouth disease |
|
| Hypopotassemia |
|
| Lipoma of other specified sites |
|
| Methicillin susceptible Staphylococcus aureus |
|
| Nausea and vomiting |
|
| Other diseases of nasal cavity and sinuses |
|
| Other specified cardiac dysrhythmias |
|
| Pilonidal cyst without mention of abscess |
|
| Pneumonia |
|
| Rash |
|
| Respiratory syncytial virus |
|
| Single seizure |
|
| Stridor |
|
| Subconjunctival hemorrhage |
|
| Umbilical hernia without obstruction/gangrene |
|
| Unspecified bacterial pneumonia |
|
| Unspecified septicemia |
|
| Urinary tract infection |
|
| Viral syndrome |
|
| Wheezing |
|
| mid-p exact binomial method |
| 0.73 |
| No |
| Superiority or Other |
| Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.03 | No | Superiority or Other |
| Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.60 | No | Superiority or Other |
| Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.38 | No | Superiority or Other |
| Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.99 | No | Superiority or Other |
| Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.13 | No | Superiority or Other |
| Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
| Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.11 | No | Superiority or Other |
| Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.53 | No | Superiority or Other |
| Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.63 | No | Superiority or Other |
| Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
| Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.53 | No | Superiority or Other |
| Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.70 | No | Superiority or Other |
| Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.36 | No | Superiority or Other |
| Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.98 | No | Superiority or Other |
| Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.04 | No | Superiority or Other |
| Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.81 | No | Superiority or Other |
| Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.75 | No | Superiority or Other |
| Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.99 | No | Superiority or Other |
| Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.13 | No | Superiority or Other |
| Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
| Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.37 | No | Superiority or Other |
| Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.12 | No | Superiority or Other |
| Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.99 | No | Superiority or Other |
| Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.63 | No | Superiority or Other |
| Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.78 | No | Superiority or Other |
| Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.84 | No | Superiority or Other |
| Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.44 | No | Superiority or Other |
| Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.41 | No | Superiority or Other |
| Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.99 | No | Superiority or Other |
| Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.63 | No | Superiority or Other |
| Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.99 | No | Superiority or Other |
| Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.28 | No | Superiority or Other |
| Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.21 | No | Superiority or Other |
| Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.98 | No | Superiority or Other |
| Acute febrile mucocutaneous lymph node syndrome |
|
| Acute otitis media |
|
| Acute pyelonephritis without RMN lesion |
|
| Adverse drug reaction |
|
| Apnea |
|
| Apparent life threatening event infant |
|
| Asthma with acute exacerbation |
|
| Asthma, unspecified, unspecified status |
|
| Bronchiolitis |
|
| Bronchitis |
|
| Bronchospasm |
|
| Candidiasis of mouth |
|
| Cellulitis and abscess of trunk |
|
| Constipation |
|
| Croup |
|
| Dehydration |
|
| Dermatitis |
|
| Dyspnea |
|
| Failure to thrive |
|
| Fever |
|
| Fussy infant |
|
| Gastroenteritis |
|
| Hand, foot and mouth disease |
|
| Hematoma |
|
| Nausea and vomiting |
|
| Neonatal candida infection |
|
| Other diseases of nasal cavity and sinuses |
|
| Other specified cardiac dysrhythmias |
|
| Pneumonia |
|
| Rash |
|
| Respiratory syncytial virus |
|
| Single seizure |
|
| Stomatitis |
|
| Stridor |
|
| Umbilical hernia without obstruction/gangrene |
|
| Unspecified septicemia |
|
| Urinary tract infection |
|
| Urticaria |
|
| Viral syndrome |
|
| Weakness |
|
| Wheezing |
|
| mid-p exact binomial method |
| 0.77 |
| No |
| Superiority or Other |
| Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.55 | No | Superiority or Other |
| Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.62 | No | Superiority or Other |
| Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
| Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.43 | No | Superiority or Other |
| Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.22 | No | Superiority or Other |
| Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.22 | No | Superiority or Other |
| Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.21 | No | Superiority or Other |
| Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.85 | No | Superiority or Other |
| Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.28 | No | Superiority or Other |
| Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.70 | No | Superiority or Other |
| Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.28 | No | Superiority or Other |
| Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.15 | No | Superiority or Other |
| Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.99 | No | Superiority or Other |
| Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.51 | No | Superiority or Other |
| Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.67 | No | Superiority or Other |
| Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.06 | No | Superiority or Other |
| Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.74 | No | Superiority or Other |
| Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.99 | No | Superiority or Other |
| Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
| Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.82 | No | Superiority or Other |
| Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
| Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.55 | No | Superiority or Other |
| Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.26 | No | Superiority or Other |
| Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.33 | No | Superiority or Other |
| Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.81 | No | Superiority or Other |
| Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.06 | No | Superiority or Other |
| Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
| Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.64 | No | Superiority or Other |
| Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.97 | No | Superiority or Other |
| Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.31 | No | Superiority or Other |
| Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
| Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.03 | No | Superiority or Other |
|
| Acute otitis media |
|
| Acute pyelonephritis without RMN lesion |
|
| Adverse drug reaction |
|
| Alkalosis |
|
| Apnea |
|
| Apparent life threatening event infant |
|
| Asthma with acute exacerbation |
|
| Asthma, unspecified, unspecified status |
|
| Bronchiolitis |
|
| Bronchitis |
|
| Bronchospasm |
|
| Candidiasis of mouth |
|
| Cellulitis and abscess of trunk |
|
| Constipation |
|
| Croup |
|
| Dehydration |
|
| Dermatitis |
|
| Dyspnea |
|
| Failure to thrive |
|
| Fever |
|
| Fussy infant |
|
| Gastroenteritis |
|
| Hand, foot and mouth disease |
|
| Hematoma |
|
| Hypopotassemia |
|
| Lipoma of other specified sites |
|
| Methicillin susceptible Staphylococcus aureus |
|
| Nausea and vomiting |
|
| Neonatal candida infection |
|
| Other diseases of nasal cavity and sinuses |
|
| Other specified cardiac dysrhythmias |
|
| Pilonidal cyst without mention of abscess |
|
| Pneumonia |
|
| Rash |
|
| Respiratory syncytial virus |
|
| Single seizure |
|
| Stomatitis |
|
| Stridor |
|
| Subconjunctival hemorrhage |
|
| Umbilical hernia without obstruction/gangrene |
|
| Unspecified bacterial pneumonia |
|
| Unspecified septicemia |
|
| Urinary tract infection |
|
| Urticaria |
|
| Viral syndrome |
|
| Weakness |
|
| Wheezing |
|
| mid-p exact binomial method |
| 0.78 |
| No |
| Superiority or Other |
| Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method.The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.13 | No | Superiority or Other |
| Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.73 | No | Superiority or Other |
| Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.23 | No | Superiority or Other |
| Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.62 | No | Superiority or Other |
| Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.99 | No | Superiority or Other |
| Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.13 | No | Superiority or Other |
| Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.06 | No | Superiority or Other |
| Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.15 | No | Superiority or Other |
| Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.28 | No | Superiority or Other |
| Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.12 | No | Superiority or Other |
| Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.68 | No | Superiority or Other |
| Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.24 | No | Superiority or Other |
| Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.61 | No | Superiority or Other |
| Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.28 | No | Superiority or Other |
| Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.62 | No | Superiority or Other |
| Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.63 | No | Superiority or Other |
| Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.66 | No | Superiority or Other |
| Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.68 | No | Superiority or Other |
| Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.18 | No | Superiority or Other |
| Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.99 | No | Superiority or Other |
| Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
| Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.37 | No | Superiority or Other |
| Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.12 | No | Superiority or Other |
| Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
| Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.82 | No | Superiority or Other |
| Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.38 | No | Superiority or Other |
| Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.78 | No | Superiority or Other |
| Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.65 | No | Superiority or Other |
| Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.17 | No | Superiority or Other |
| Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.22 | No | Superiority or Other |
| Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.81 | No | Superiority or Other |
| Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.13 | No | Superiority or Other |
| Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.99 | No | Superiority or Other |
| Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.99 | No | Superiority or Other |
| Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
| Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.96 | No | Superiority or Other |
| Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.97 | No | Superiority or Other |
| Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.19 | No | Superiority or Other |
| Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.25 | No | Superiority or Other |
| Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.03 | No | Superiority or Other |
|
| Acute otitis media |
|
| Acute pyelonephritis without RMN lesion |
|
| Alkalosis |
|
| Apnea |
|
| Apparent life threatening event infant |
|
| Asthma with acute exacerbation |
|
| Asthma, unspecified, unspecified status |
|
| Bronchiolitis |
|
| Bronchitis |
|
| Bronchospasm |
|
| Candidiasis of mouth |
|
| Cellulitis and abscess of trunk |
|
| Constipation |
|
| Croup |
|
| Dehydration |
|
| Dermatitis |
|
| Dyspnea |
|
| Failure to thrive |
|
| Fever |
|
| Fussy infant |
|
| Gastroenteritis |
|
| Hand, foot and mouth disease |
|
| Hypopotassemia |
|
| Lipoma of other specified sites |
|
| Methicillin susceptible Staphylococcus aureus |
|
| Nausea and vomiting |
|
| Neonatal bradycardia |
|
| Other diseases of nasal cavity and sinuses |
|
| Other specified cardiac dysrhythmias |
|
| Pilonidal cyst without mention of abscess |
|
| Pneumonia |
|
| Primary apnea of newborn |
|
| Rash |
|
| Respiratory syncytial virus |
|
| Retinopathy of prematurity stage 2 |
|
| Single seizure |
|
| Stridor |
|
| Subconjunctival hemorrhage |
|
| Umbilical hernia without obstruction/gangrene |
|
| Unspecified bacterial pneumonia |
|
| Unspecified septicemia |
|
| Urinary tract infection |
|
| Urticaria |
|
| Viral syndrome |
|
| Weakness |
|
| Wheezing |
|
| mid-p exact binomial method |
| 0.03 |
| No |
| Superiority or Other |
| Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.13 | No | Superiority or Other |
| Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.73 | No | Superiority or Other |
| Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.26 | No | Superiority or Other |
| Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.05 | No | Superiority or Other |
| Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.40 | No | Superiority or Other |
| Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.20 | No | Superiority or Other |
| Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.41 | No | Superiority or Other |
| Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.59 | No | Superiority or Other |
| Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.10 | No | Superiority or Other |
| Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.95 | No | Superiority or Other |
| Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.05 | No | Superiority or Other |
| Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.93 | No | Superiority or Other |
| Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.56 | No | Superiority or Other |
| Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.79 | No | Superiority or Other |
| Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.46 | No | Superiority or Other |
| Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.92 | No | Superiority or Other |
| Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.73 | No | Superiority or Other |
| Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.40 | No | Superiority or Other |
| Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.93 | No | Superiority or Other |
| Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.82 | No | Superiority or Other |
| Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.04 | No | Superiority or Other |
| Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.69 | No | Superiority or Other |
| Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.53 | No | Superiority or Other |
| Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.59 | No | Superiority or Other |
| Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.07 | No | Superiority or Other |
| Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.06 | No | Superiority or Other |
| Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.85 | No | Superiority or Other |
| Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.02 | No | Superiority or Other |
| Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method] | 0.33 | No | Superiority or Other |
| Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.59 | No | Superiority or Other |
| Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.07 | No | Superiority or Other |
| Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.53 | No | Superiority or Other |
| Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.03 | No | Superiority or Other |
| Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.21 | No | Superiority or Other |
| Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.73 | No | Superiority or Other |
| Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.73 | No | Superiority or Other |
| Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.94 | No | Superiority or Other |
|
| Acute otitis media |
|
| Acute pyelonephritis without RMN lesion |
|
| Adverse drug reaction |
|
| Alkalosis |
|
| Apnea |
|
| Apparent life threatening event infant |
|
| Asthma with acute exacerbation |
|
| Asthma, unspecified, unspecified status |
|
| Bronchiolitis |
|
| Bronchitis |
|
| Bronchospasm |
|
| Candidiasis of mouth |
|
| Cellulitis and abscess of trunk |
|
| Constipation |
|
| Croup |
|
| Dehydration |
|
| Dermatitis |
|
| Dyspnea |
|
| Failure to thrive |
|
| Fever |
|
| Fussy infant |
|
| Gastroenteritis |
|
| Hand, foot and mouth disease |
|
| Hematoma |
|
| Nausea and vomiting |
|
| Neonatal candida infection |
|
| Other diseases of nasal cavity and sinuses |
|
| Other specified cardiac dysrhythmias |
|
| Pneumonia |
|
| Rash |
|
| Respiratory syncytial virus |
|
| Single seizure |
|
| Stomatitis |
|
| Stridor |
|
| Subconjunctival hemorrhage |
|
| Umbilical hernia without obstruction/gangrene |
|
| Unspecified septicemia |
|
| Urinary tract infection |
|
| Urticaria |
|
| Vaccines adverse reaction |
|
| Viral syndrome |
|
| Weakness |
|
| Wheezing |
|
| mid-p exact binomial method |
| 0.43 |
| No |
| Superiority or Other |
| Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.01 | No | Superiority or Other |
| Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.93 | No | Superiority or Other |
| Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.32 | No | Superiority or Other |
| Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.24 | No | Superiority or Other |
| Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.41 | No | Superiority or Other |
| Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.06 | No | Superiority or Other |
| Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.31 | No | Superiority or Other |
| Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.43 | No | Superiority or Other |
| Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.50 | No | Superiority or Other |
| Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.51 | No | Superiority or Other |
| Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.48 | No | Superiority or Other |
| Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.44 | No | Superiority or Other |
| Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.70 | No | Superiority or Other |
| Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.87 | No | Superiority or Other |
| Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.05 | No | Superiority or Other |
| Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.24 | No | Superiority or Other |
| Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.24 | No | Superiority or Other |
| Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.03 | No | Superiority or Other |
| Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.37 | No | Superiority or Other |
| Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.16 | No | Superiority or Other |
| Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.85 | No | Superiority or Other |
| Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.67 | No | Superiority or Other |
| Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.18 | No | Superiority or Other |
| Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.08 | No | Superiority or Other |
| Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.63 | No | Superiority or Other |
| Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.66 | No | Superiority or Other |
| Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.31 | No | Superiority or Other |
| Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.22 | No | Superiority or Other |
| Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.96 | No | Superiority or Other |
| Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.67 | No | Superiority or Other |
| Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.23 | No | Superiority or Other |
| Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.14 | No | Superiority or Other |
| Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.07 | No | Superiority or Other |
| Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.74 | No | Superiority or Other |
| Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.69 | No | Superiority or Other |
| Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.01 | No | Superiority or Other |
| Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.72 | No | Superiority or Other |
| Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.07 | No | Superiority or Other |
| Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.07 | No | Superiority or Other |
| Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.73 | No | Superiority or Other |
|
| Acute otitis media |
|
| Acute pyelonephritis without RMN lesion |
|
| Adverse drug reaction |
|
| Alkalosis |
|
| Apnea |
|
| Apparent life threatening event infant |
|
| Asthma with acute exacerbation |
|
| Asthma, unspecified, unspecified status |
|
| Bronchiolitis |
|
| Bronchitis |
|
| Bronchospasm |
|
| Candidiasis of mouth |
|
| Cellulitis and abscess of trunk |
|
| Constipation |
|
| Croup |
|
| Dehydration |
|
| Dermatitis |
|
| Dyspnea |
|
| Failure to thrive |
|
| Fever |
|
| Fussy infant |
|
| Gastroenteritis |
|
| Hand, foot and mouth disease |
|
| Hematoma |
|
| Hypopotassemia |
|
| Lipoma of other specified sites |
|
| Methicillin susceptible Staphylococcus aureus |
|
| Nausea and vomiting |
|
| Neonatal bradycardia |
|
| Neonatal candida infection |
|
| Other diseases of nasal cavity and sinuses |
|
| Other specified cardiac dysrhythmias |
|
| Pilonidal cyst without mention of abscess |
|
| Pneumonia |
|
| Primary apnea of newborn |
|
| Rash |
|
| Respiratory syncytial virus |
|
| Retinopathy of prematurity stage 2 |
|
| Single seizure |
|
| Stomatitis |
|
| Stridor |
|
| Subconjunctival hemorrhage |
|
| Umbilical hernia without obstruction/gangrene |
|
| Unspecified bacterial pneumonia |
|
| Unspecified septicemia |
|
| Urinary tract infection |
|
| Urticaria |
|
| Vaccines adverse reaction |
|
| Viral syndrome |
|
| Weakness |
|
| Wheezing |
|
| mid-p exact binomial method |
| 0.02 |
| No |
| Superiority or Other |
| Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.27 | No | Superiority or Other |
| Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.02 | No | Superiority or Other |
| Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.18 | No | Superiority or Other |
| Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.93 | No | Superiority or Other |
| Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.05 | No | Superiority or Other |
| Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.52 | No | Superiority or Other |
| Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.17 | No | Superiority or Other |
| Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.21 | No | Superiority or Other |
| Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.05 | No | Superiority or Other |
| Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.63 | No | Superiority or Other |
| Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.46 | No | Superiority or Other |
| Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.42 | No | Superiority or Other |
| Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.49 | No | Superiority or Other |
| Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.69 | No | Superiority or Other |
| Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.28 | No | Superiority or Other |
| Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.69 | No | Superiority or Other |
| Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.95 | No | Superiority or Other |
| Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.13 | No | Superiority or Other |
| Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.57 | No | Superiority or Other |
| Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.18 | No | Superiority or Other |
| Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.03 | No | Superiority or Other |
| Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.45 | No | Superiority or Other |
| Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.21 | No | Superiority or Other |
| Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.66 | No | Superiority or Other |
| Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.67 | No | Superiority or Other |
| Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.04 | No | Superiority or Other |
| Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.69 | No | Superiority or Other |
| Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.53 | No | Superiority or Other |
| Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.16 | No | Superiority or Other |
| Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.07 | No | Superiority or Other |
| Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.08 | No | Superiority or Other |
| Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.98 | No | Superiority or Other |
| Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.04 | No | Superiority or Other |
| Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.22 | No | Superiority or Other |
| Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.02 | No | Superiority or Other |
| Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.17 | No | Superiority or Other |
| Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.87 | No | Superiority or Other |
| Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.07 | No | Superiority or Other |
| Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.54 | No | Superiority or Other |
| Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.23 | No | Superiority or Other |
| Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.24 | No | Superiority or Other |
| Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.24 | No | Superiority or Other |
| Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.04 | No | Superiority or Other |
| Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.21 | No | Superiority or Other |
| Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.29 | No | Superiority or Other |
| Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.06 | No | Superiority or Other |
| Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.61 | No | Superiority or Other |
| Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.07 | No | Superiority or Other |
| Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | <0.01 | No | Superiority or Other |
| Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.04 | No | Superiority or Other |
| Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1. | mid-p exact binomial method | 0.68 | No | Superiority or Other |