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PAPERBACK list:$37.00 Web:$33.30 add to cart Rights & Permissions Free PDF Access Free Resources Sign in to download PDF book and chapters PDF EXECUTIVE SUMMARY Display this book on your site! Related Titles An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program Immunization Safety Review: Vaccines and Autism Other Related Titles The Anthrax Vaccine: Is It Safe? Does It Work? (2002) Institute of Medicine (IOM) Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Page 245   E-mail  Facebook  Digg  Stumble  Twitter More The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine Page 245 Front Matter (R1-R22) Executive Summary (1-32) 1 Introduction (33-39) 2 Background (40-55) 3 Anthrax Vaccine Efficacy (56-82) 4 Safety: Introduction (83-101) 5 Safety: Case Reports (102-117) 6 Safety: Epidemiologic Studies (118-179) 7 Anthrax Vaccine Manufacture (180-197) 8 Future Needs (198-210) Appendix A Statement of Task (211-213) Appendix B Biographical Sketches (214-217) Appendix C Information-Gathering Meeting Agendas (218-226) Appendix D Anthrax Vaccine Adsorbed Package Inserts (227-238) Appendix E Vaccine Adverse Event Reporting System (VAERS) Form (239-242) Appendix F Anthrax Vaccine Expert Committee (AVEC) Case Assessment Form (243-244) Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine (245-252) Appendix H An Assessment of the Safety of the Anthrax Vaccine: A Letter Report (253-266)

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The Anthrax Vaccine: Is it Safe? Does it Work? Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine

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The Anthrax Vaccine: Is it Safe? Does it Work? TABLE G-1 Among Service Members Receiving at Least One Dose of AVA Hospitalization Diagnoses with Rate Ratios Above 1.0, U.S. Armed Forces, Active Duty, 1998 to 2000 ICD-9-CM Code(s) Description Anthrax Immunization Status Adjusted Rate Ratio 95% Confidence Intervals Post Pre Number Rate per 100,000 Number Rate per 100,000 193 Malignant neoplasm of thyroid gland 41 5.6 9 1.9 2.40 1.05 5.49 233 Carcinoma in situ of breast and genitourinary system 19 2.6 5 1.0 5.14 1.81 14.57 250 Diabetes mellitus 67 9.1 8 1.7 3.46 1.51 7.90 296 Affective psychoses 600 81.3 120 25.1 2.15 1.71 2.71 298 Other nonorganic psychoses 69 9.3 14 2.9 2.50 1.29 4.83 309 Adjustment reaction 1,219 165.1 403 84.3 1.38 1.20 1.59 311 Depressive disorder, not elsewhere classified 187 22.6 46 9.6 1.79 1.21 2.66 374 Other disorders of eyelids 16 2.2 7 1.5 2.71 1.05 7.00 550 Inguinal hemia 293 39.7 172 35.0 1.31 1.04 1.65 569 Other disorders of intestine 34 4.6 6 1.3 2.94 1.23 7.07 724 Other and unspecified disorders of back 108 14.6 38 7.9 1.51 1.04 2.20 726 Peripheral enthesopathies and allied syndromes 213 28.8 97 20.3 1.29 1.01 1.64 732 Osteochondropathies 38 5.1 11 2.3 2.03 1.03 3.98 808 Fracture of pelvis 53 7.2 16 3.3 1.81 1.03 3.20 823 Fracture of tibia and fibula 169 22.9 60 12.5 1.63 1.14 2.32

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The Anthrax Vaccine: Is it Safe? Does it Work? TABLE G-2 Among Service Members Receiving at Least One Dose of AVA, Hospitalization Diagnoses with Rate Ratios Above 1.0, by Number of Days after Immunization, U.S. Armed Forces, Active Duty, 1998 to 2000 ICD-9-CM Code(s) Description Anthrax immunization Status Comparison* Pre 0-45 days >45days 0-45/Pre >45/Pre Number Rate per 100,000 Number Rate per 100,000 Number Rate per 100,000 Adjusted Rate Ratio 98% CI Adjusted Rate Ratio 95% CI 193 Malignant neoplasm of thyroid gland 9 1.88 10 6.04 31 5.41 2.88 1.12 7.37 2.16 0.90 5.17 220 Benign neoplasm of ovary 9 1.88 8 4.83 12 2.10 2.61 1.01 6.77 1.13 0.48 2.68 233 Carcinoma in situ of breast and genitourinary system 5 1.05 5 3.02 14 2.44 4.12 1.17 14.49 5.85 1.95 17.58 250 Diabetes mellitus 8 1.67 13 7.85 54 9.43 3.49 1.39 8.79 3.44 1.47 8.06 296 Affective psychoses 120 25.10 102 61.56 498 86.96 1.84 1.39 2.43 2.31 1.82 2.94 298 Other nonorganic psychoses 14 2.93 9 5.43 60 10.48 1.52 0.64 3.62 3.08 1.55 6.13 304 Drug dependence 6 1.25 2 1.21 33 5.76 . . . 3.06 1.08 8.66 309 Adjustment reaction 403 84.29 258 155.72 961 167.80 1.37 1.16 1.62 1.38 1.19 1.61 311 Depressive disorder, not elsewhere classified 46 9.62 35 21.12 132 23.05 1.78 1.11 2.84 1.80 1.19 2.72 312 Disturbance of conduct, not elsewhere classified 6 1.25 0 0.00 12 2.10 . . . 1.41 1.41 1.41 414 Other forms of chronic ischemic heart disease 18 3.76 20 12.07 81 14.14 2.15 1.09 4.23 1.65 0.89 3.07 429 III-defined desoriptions and complications of heart disease 6 1.25 0 0.00 12 2.10 . . . 1.32 1.32 1.32 451 Phlebitis and thrombophlebitis 5 1.05 0 0.00 12 2.10 . . . 1.58 1.58 1.58 470 Deviated nasal septum 45 9.41 23 13.88 90 15.72 1.19 0.72 1.97 1.47 1.02 2.11 493 Asthma 41 8.58 30 18.11 64 11.18 1.83 1.14 2.93 1.10 0.74 1.64 541 Appendicitis, unqualified 47 9.83 19 11.47 77 13.45 1.15 0.68 1.97 1.46 1.01 2.11 550 Inguinal hernia 172 35.98 76 45.87 217 37.89 1.24 0.93 1.65 1.36 1.05 1.76 569 Other disorders of intestine 6 1.25 10 6.04 24 4.19 4.16 1.51 11.49 2.61 1.06 6.44 598 Urethral stricture 22 5.18 8 5.38 51 9.89 0.96 0.43 2.16 1.66 1.00 2.75 622 Noninflammatory disorders of cervix 15 28.20 22 129.54 48 84.26 2.64 1.30 5.35 1.55 0.78 3.09 724 Other and unspecified disorders of back 38 7.95 19 11.47 89 15.54 1.25 0.72 2.18 1.59 1.08 2.33 733 Other disorders of bone and cartilage 95 19.87 45 27.16 194 33.87 1.12 0.77 1.62 1.45 1.06 1.98 735 Acquired deformities of toe 34 7.11 20 12.07 83 14.49 1.15 0.66 2.01 1.58 1.06 2.37 808 Fracture of pelvis 16 3.35 11 6.64 42 7.33 1.66 0.77 3.60 1.86 1.04 3.34 823 Fracture of tibia and fibula 60 12.55 36 21.73 133 23.22 1.53 0.99 2.37 1.68 1.15 2.46 865 Injury to spleen 9 1.88 10 6.04 19 3.32 2.83 1.15 6.99 1.61 0.72 3.58 999 Complications of medical care, not elsewhere classified 7 1.46 5 3.02 5 0.87 3.70 1.05 13.04 1.25 0.30 5.11

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The Anthrax Vaccine: Is it Safe? Does it Work? TABLE G-3 Among Service Members Receiving at Least One Dose of AVA, Hospitalization Diagnoses with Rate Ratios Above 1.0, by Number of Doses After Immunization, U.S. Armed Forces, Active Duty, 1998 to 2000   Anthrax Immunization Status Comparison Pre 1 to 3 doses 4 or more doses 1 to 3 doses/Pre 4 or more/Pre ICD-9-CM Description Number Rate/100,000 Number Rate/100,000 Number Rate/100,000 Adjusted Rate ratio 95% CI Adjusted Rate ratio 95% CI 193 Malignant neoplasm of thyroid gland 9 1.88 12 6.51 29 5.23 2.55 0.94-6.94 2.35 1.01-5.48 225 Benign neoplasm of brain and other parts of nervous system 6 1.25 8 4.34 6 1.08 2.99 1.02-8.77 0.70 0.22-2.19 250 Diabetes mellitus 8 1.67 24 13.02 43 7.76 4.98 2.02-12.25 3.05 1.31-7.09 296 Affective psychoses 120 25.10 229 124.27 371 66.95 3.65 2.81-4.74 1.79 1.42-2.27 298 Other nonorganic psychoses 14 2.93 26 14.11 43 7.76 4.08 1.92-8.68 2.11 1.07-4.18 300 Neurotic disorders 69 14.43 70 37.99 101 18.23 2.20 1.46-3.30 0.92 0.64-1.32 301 Personality disorders 64 13.39 115 62.41 81 14.62 1.95 1.32-2.87 0.69 0.46-1.02 304 Drug dependence 6 1.25 13 7.05 22 3.97 4.20 1.37-12.91 1.81 0.64-5.07 309 Adjustment reaction 403 84.29 460 249.63 759 136.98 2.28 1.94-2.69 1.16 1.00-1.34 311 Depressive disorder, not elsewhere classified 46 9.62 49 26.59 118 21.30 2.60 1.62-4.20 1.63 1.09-2.44 346 Migraine 36 7.53 30 16.28 46 8.30 1.82 1.12-2.98 0.90 0.58-1.40

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The Anthrax Vaccine: Is it Safe? Does it Work? 348 Other conditions of brain 7 1.46 9 4.88 8 1.44 2.80 1.03-7.63 0.78 0.28-2.19 410 Acute myocardial infarction 22 4.60 24 13.02 44 7.94 2.60 1.42-4.75 1.15 0.69-1.94 470 Deviated nasal septum 45 9.41 18 9.77 95 17.14 1.15 0.65-2.00 1.47 1.02-2.10 493 Asthma 41 8.58 36 19.54 58 10.47 2.18 1.37-3.47 1.00 0.67-1.51 550 Inguinal hernia 172 35.98 55 29.85 238 42.95 1.24 0.88-1.75 1.32 1.04-1.68 555 Regional enteritis 5 1.05 19 10.31 20 3.61 4.90 1.55-15.44 1.96 0.65-5.95 569 Other disorders of intestine 6 1.25 6 3.26 28 5.05 2.05 0.66-6.41 3.24 1.33-7.89 724 Other and unspecified disorders of back 38 7.95 26 14.11 82 14.80 1.78 1.06-2.98 1.45 0.98-2.13 726 Peripheral enthesopathies and allied syndromes 97 20.29 57 30.93 156 28.15 1.49 1.07-2.09 1.04 0.80-1.34 732 Osteochondropathies 11 2.30 6 3.26 32 5.78 1.50 0.55-4.12 2.17 1.09-4.32 733 Other disorders of bone and cartilage 95 19.87 68 36.90 171 30.86 1.77 1.22-2.56 1.23 0.91-1.66 735 Acquired deformities of toe 34 7.11 12 6.51 91 16.42 0.93 0.48-1.82 1.60 1.07-2.39 808 Fracture of pelvis 16 3.35 15 8.14 38 6.86 2.47 1.20-5.09 1.64 0.91-2.98 813 Fracture of radius and ulna 102 21.33 54 29.30 114 20.57 1.62 1.10-2.37 1.13 0.83-1.54 823 Fracture of tibia and fibula 60 12.55 50 27.13 119 21.48 1.93 1.24-3.01 1.55 1.07-2.23 844 Sprains and strains of knee and leg 113 23.64 64 34.73 167 30.14 1.67 1.22-2.29 1.10 0.86-1.39 851 Cerebral laceration and contusion 8 1.67 2 1.09 22 3.97 - - 2.43 1.08-5.47 891 Open wound of knee, leg [ except thigh ], and ankle 18 3.76 18 9.77 28 5.05 2.10 1.08-4.11 1.26 0.70-2.29 998 Other complications of procedures, not elsewhere classified 157 32.84 112 60.78 250 45.12 1.51 1.13-2.02 1.11 0.87-1.41

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The Anthrax Vaccine: Is it Safe? Does it Work? TABLE G-4 Among all Service Members, Hospitalization Diagnoses with Rate Ratios Above 1.0, U.S. Armed Forces, Active Duty, 1998 to 2000 ICD-9-CM Code(s) Description Anthrax Immunization Status Adjusted Rate Ratio 95% Confidence Intervals Pre Never Number Rate per 100,000 Number Rate per 100,000 084 Malaria 18 3.8 62 2.1 1.76 1.04 2.99 695 Erythematous conditions 9 1.9 22 0.8 2.74 1.25 6.00 913 Superficial injury of elbow, forearm, and wrist 10 2.1 17 0.6 3.37 1.53 7.45 986 Toxic effect of carbon monoxide 8 1.7 8 0.3 7.49 2.74 20.46 993 Effects of air pressure 11 2.3 46 1.6 2.05 1.01 4.17

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The Anthrax Vaccine: Is it Safe? Does it Work? TABLE G-5 Among All Service Members, Rates of Hospitalization for Specific Diagnoses and Adjusted Rate Ratios Comparing Hospitalization Rates Following at Least One Dose of AVA (“Post”) with Hospitalization Rates Before First AVA Dose (“Pre”), by Sex, U.S. Armed Forces, Active Duty, 1998 to 2000   ICD-9-CM Code(s) Description Anthrax Immunization Status Adjusted Rate Ratio 95% Confidence Intervals Post Pre Number Rate per 100,000 Number Rate per 100,000 Both Sexes 710-719 Arthropathies and related disorders 1,543 209.0 7,674 227.8 0.88 0.83 0.93 493 Asthma 94 12.7 629 18.7 0.63 0.51 0.79 710 Diffuse diseases of connective tissue 9 1.2 61 1.8 0.86 0.42 1.78 250 Diabetes mellitus 67 9.1 445 13.2 0.65 0.50 0.84 380-389 Diseases of the ear and mastoid process 67 9.1 368 10.9 0.87 0.67 1.14 357 Inflammatory and toxic neuropathy 13 1.8 89 2.6 0.75 0.41 1.35 427 Cardiac dysrhythmias 170 23.0 998 29.6 0.77 0.65 0.91 200-208 Lymphosarcoma and reticulosarcoma 43 5.8 311 9.2 0.70 0.51 0.97 340 Multiple sclerosis 32 4.3 103 3.1 1.31 0.87 1.98 410 Acute myocardial infarction 68 9.2 384 11.4 0.97 0.74 1.27 240-246 Disorders of thyroid gland 48 6.5 334 9.9 0.76 0.56 1.04 530-537 Diseases of esophagus, stomach, and duodenum 475 64.3 2,135 63.4 1.02 0.92 1.13

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The Anthrax Vaccine: Is it Safe? Does it Work?   ICD-9-CM Code(s) Description Anthrax Immunization Status Adjusted Rate Ratio 95% Confidence Intervals Post Pre Number Rate per 100,000 Number Rate per 100,000 Women 710-719 Arthropathies and related disorders 133 179.9 849 166.7 1.02 0.84 1.23 493 Asthma 21 28.4 197 38.7 0.67 0.42 1.06 710 Diffuse diseases of connective tissue 4 5.4 39 7.7 . . . 250 Diabetes mellitus 4 5.4 40 7.9 . . . 380-389 Diseases of the ear and mastoid process 10 13.5 73 14.3 1.11 0.56 2.18 357 Inflammatory and toxic neuropathy 3 4.1 16 3.1 . . . 427 Cardiac dysrhythmias 11 14.9 87 17.1 0.98 0.52 1.84 200-208 Lymphosarcoma and reticulosarcoma 3 4.1 45 8.8 . . . 340 Multiple sclerosis 15 20.3 34 6.7 2.14 1.14 4.01 410 Acute myocardial infarction 1 1.4 14 2.7 . . . 240-246 Disorders of thyroid gland 23 31.1 175 34.4 0.90 0.58 1.40 530-537 Diseases of esophagus, stomach, and duodenum 40 54.1 278 54.6 1.04 0.74 1.45 Men 710-719 Arthropathies and related disorders 1,410 212.2 6,825 238.7 0.86 0.81 0.91 493 Asthma 73 11.0 432 15.1 0.65 0.50 0.83 710 Diffuse diseases of connective tissue 5 0.8 22 0.8 0.85 0.32 2.25 250 Diabetes mellitus 63 9.5 405 14.2 0.65 0.50 0.85 380-389 Diseases of the ear and mastoid process 57 8.6 295 10.3 0.87 0.65 1.16 357 Inflammatory and toxic neuropathy 10 1.5 73 2.6 0.71 0.36 1.40 427 Cardiac dysrhythmias 159 23.9 911 31.9 0.76 0.64 0.90 200-208 Lymphosarcoma and reticulosamoma 40 6.0 266 9.3 0.76 0.54 1.08 340 Multiple sclerosis 17 2.6 69 2.4 1.00 0.58 1.73 410 Acute myocardial infarction 67 10.1 370 12.9 0.97 0.74 1.27 240-246 Disorders of thyroid gland 25 3.8 159 5.6 0.68 0.44 1.04 530-537 Diseases of esophagus, stomach, and duodenum 435 65.5 1,857 65.0 1.02 0.91 1.13 NOTE: Prevaccination population includes personnel who never received AVA.

Representative terms from entire chapter:

hospitalization diagnoses