N/A
N=21,240
A Safety Study For Prevenar 13 Among Chinese Children
Seizures · Urticaria and Angioedema · Apnea · Fever
Bottom Line
View on ClinicalTrials.gov: NCT03656939 ↗Enrolled (actual)
21,240
Serious AEs
—
Results posted
Aug 2021
Primary outcome: Primary: Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 1 — NA; NA Events per 1000 person-days
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 1 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 1 |
0.025; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 1 |
0.012; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 1 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 1 |
0.012; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 1 |
0.006; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1 |
0.012; 0.326; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1 |
0.025; NA; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1 |
0.019; 0.163; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 1 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 1 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 1 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 1 |
0.555; 10.689 | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 1 |
0.049; 0.544 | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 1 |
0.296; 5.649 | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 2 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 2 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 2 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 2 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 2 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 2 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2 |
0.065; 0.227; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2 |
0.129; NA; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2 |
0.097; 0.114; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 2 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 2 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 2 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 2 |
0.517; 4.14 | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 2 |
0.116; 0.568 | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 2 |
0.310; 2.362 | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 3 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 3 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 3 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 3 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 3 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 3 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3 |
0.054; NA; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3 |
0.136; NA; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3 |
0.095; NA; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 3 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 3 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 3 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 3 |
0.367; 2.834 | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 3 |
0.190; 0.489 | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 3 |
0.279; 1.604 | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 4 |
0.058; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 4 |
0.039; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 4 |
0.048; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 4 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 4 |
0.019; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 4 |
0.010; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4 |
0.29; 0.388; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4 |
0.483; NA; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4 |
0.387; 0.194; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 4 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 4 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 4 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 4 |
1.278; 15.822 | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 4 |
1.298; 3.124 | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 4 |
1.194; 9.54 | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After All Doses |
0.011; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After All Doses |
0.014; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After All Doses |
0.012; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After All Doses |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After All Doses |
0.007; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After All Doses |
0.004; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After All Doses |
0.088; 0.223; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After All Doses |
0.165; NA; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After All Doses |
0.127; 0.112; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After All Doses |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After All Doses |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After All Doses |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After All Doses |
0.627; 7.575 | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After All Doses |
0.331; 0.958 | — |
| PRIMARY Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After All Doses |
0.458; 4.261 | — |
| PRIMARY Incidence Rate (IR) (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 1 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 1 |
0.098; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 1 |
0.098; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 1 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 1 |
0.049; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 1 |
0.049; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1 |
0.049; 1.304; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1 |
0.098; NA; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1 |
0.148; 1.304; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 1 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 1 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 1 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 1 |
2.215; 41.304 | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 1 |
0.197; 2.174 | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 1 |
2.362; 43.478 | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 2 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 2 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 2 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 2 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 2 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 2 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2 |
0.258; 0.908; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2 |
0.516; NA; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2 |
0.774; 0.908; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 2 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 2 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 2 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 2 |
2.063; 16.341 | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 2 |
0.464; 2.270 | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 2 |
2.476; 18.611 | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 3 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 3 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 3 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 3 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 3 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 3 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3 |
0.217; NA; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3 |
0.543; NA; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3 |
0.760; NA; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 3 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 3 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 3 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 3 |
1.466; 11.236 | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 3 |
0.760; 1.954 | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 3 |
2.226; 12.702 | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 4 |
0.232; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 4 |
0.155; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 4 |
0.386; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 4 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 4 |
0.077; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 4 |
0.077; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4 |
1.159; 1.549; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4 |
1.931; NA; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4 |
3.090; 1.549; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 4 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 4 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 4 |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 4 |
5.099; 60.418 | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 4 |
5.176; 12.394 | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 4 |
9.503; 72.037 | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After All Doses |
0.042; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After All Doses |
0.056; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After All Doses |
0.099; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After All Doses |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After All Doses |
0.028; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After All Doses |
0.028; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After All Doses |
0.352; 0.893; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After All Doses |
0.661; NA; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After All Doses |
1.013; 0.893; NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After All Doses |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After All Doses |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After All Doses |
NA; NA | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After All Doses |
2.505; 29.588 | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After All Doses |
1.323; 3.826 | — |
| PRIMARY Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After All Doses |
3.659; 33.159 | — |
Summary
This is an observational study based on a population-based EHR database.
Eligibility Criteria
Inclusion Criteria
To be eligible for the main study, children in Yinzhou population-based EHR database must be aged 1 to 24 months and receive at least one dose of 13vPnC between May 1st, 2017 and July 24th, 2020 where the first dose is received before or on July 24th, 2020 since a 7-day post-vaccination follow-up for each dose in each child receiving 13vPnC is needed. For the prospective cohort in a sub-population of the main study, eligible children for the main study must receive the first dose of 13vPnC between August 1st, 2018 and July 24th, 2020 and an informed consent must be obtained from parents/legal guardians.
Exclusion Criteria
There are no exclusion criteria for this study.
Data sourced from ClinicalTrials.gov (NCT03656939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.