GSK Medicine: Cervarix® (HPV): GlaxoSmithKline (GSK) Biologicals’ adjuvanted Human Papilloma Viruses (HPV) -16/18 L1 virus-like particles (VLP) vaccine. Study No.: HPV (580299) -Meta-analysis-201110 Title: Integrated safety summary of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix®) Rationale: The aim of this analyses was to provide an additional update to the pooled analysis of safety (previously performed in 2006), justified by a significant number of additional subjects included in ongoing clinical trials. This pooled analysis included all completed and ongoing studies in which the HPV licensed vaccine was administered to females 9 years of age and above. Objectives: To assess the effect of HPV vaccine on safety and pregnancy outcomes, when administered alone or coadministered with another vaccine. Indication: HPV Study Investigators/Centers: GSK conducted study Research Methods: Data Source: All interventional GSK sponsored studies for the first file submission of HPV vaccine in 2006 and additional update to the pooled analysis of safety that were completed before or on 30 April 2011 defined as the data lock point (DLP). As some of the studies included in the analysis were ongoing without a planned interim analysis at the time of the DLP, data from these studies might not have been cleaned or only partially cleaned. For completed studies included in the analyses, archived databases were used. For all ongoing studies, the DLP was applied except for study 104820 which the validated database up to Month 48 was used (DLP for 104820: 18 May 2011). All females that received either the investigational HPV vaccine (alone or co-administered with another study vaccine) or control vaccine in eligible studies were included. Eligible studies include: 580299_003, 580299_004, 580299_005, 580299_001, 580299_007, 109616, 109624, 109625, 580299_008, 580299_009, 108933,, 580299_012, 580299_012_ESFU, 107476, 107477, 107479, 107481, 580299_013, 580299_013 ESFU, 104896, 104902, 104904, 104918, 111375, 103514, 103514_ESFU, 105879, 105880, 105881, 105882, 112772, 104820, 104772, 104772_ESFU, 107682, 107682_ESFU, 109823, 107863, 106069, 109628, 111567, 110886, 111507, 104479, 104798, 112949, 104951, 107336, 106001, 105926, 107291, 107638, 108464, 109179, 110168, 110659, 111758, 111712, 111955, 112022, 112485, 113618, 113621, 114590, 108160, 109836, 102115, 108052, 107919, 107921, 107918. As some studies were still ongoing, data presented in this CTRS are still blinded. For data concerning those individual studies, please refer to the individual CTRS. Study Design: Analyses of safety pooling data from female subjects aged 9 years and above, who participated in HPV studies designed with investigational HPV vaccine, another co-administered vaccine and/or control vaccine. Study Population: Female subjects aged 9 years and above and who had participated in a HPV study and had received at least one vaccine dose. The following groups were used for the pooled statistical analyses: HPV Group: subjects who received at least 1 dose of Cervarix® (not co-administered with any other study vaccine). HPV Co-Admin Group: subjects who received the investigational HPV vaccine co-administered with another study vaccine. Control Group: subjects who received a control or placebo vaccine. Study Exposures, Outcomes: The data were collected based on the following study outcomes: Primary Outcomes: Occurrence of medically significant conditions* (MSCs), regardless of causal relationship to vaccination and intensity throughout the entire study period Occurrence of potential immune mediated diseases (pIMDs) either reported as such for new studies or detected in the database by a search of Medical Dictionary of Regulatory Activities (MedDRA) preferred Terms related to immune mediated diseases, regardless of causal relationship to vaccination and intensity throughout the entire study period Occurrence of any, Grade 3 and causally related to vaccination unsolicited AEs, within the 30-day period (Days 0 29) following any vaccination. Occurrence of Serious Adverse Events (SAEs) and SAEs with causal relationship to vaccination throughout the entire study period Occurrence of deaths, regardless of causal relationship to vaccination throughout the entire study period Occurrence of pregnancies and pregnancy outcomes throughout the entire study period *MSCs are defined as AEs prompting emergency room (ER) or physician visits (MD) that are not (1) related to common
diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases. Data Analysis Methods: The analyses were performed on the Total Vaccinated Cohort: – The Total Vaccinated Cohort included all vaccinated subjects who received at least one dose of vaccine/control. The percentage of subjects with at least one report of MSC classified by the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms and reported throughout the entire study period was tabulated for the 3 groups. The percentage of subjects with at least one report of pIMDs reported as such for new studies or classified by MedDRA preferred terms related to immune mediated diseases, regardless of causal relationship to vaccination and intensity was tabulated throughout the entire study period for the same groups. The percentage of subjects with at least one report of unsolicited AE classified by MedDRA preferred terms and reported up to 30 days (Days 0 -29) after vaccination was tabulated for each group. The same tabulation was performed for Grade 3 unsolicited AEs and for unsolicited AEs with relationship to vaccination. The numbers of subjects with any SAEs and SAEs with causal relationship to vaccination were tabulated throughout the entire study period. The total number of Deaths was also reported. Pregnancies and their outcomes were reported for each group throughout the entire study period. Limitations: Subjects enrolled after 30 April 2011 in any of the ongoing studies, did not contribute to the analyses. Any event occurring after 30 April 2011 was not included in this analysis. The number of subjects (N) may vary in the different tables as not all the outcomes have been collected for each study. Study Results: Demographic/Baseline Characteristics: HPV Group HPV Co-admin Group Control Group Enrolled, N (Total Vaccinated Cohort) 31173 2166 24241 Mean age, years (SD) 22.9 (7.8) 13.4 (3.0) 22.7 (7.6) Females: Males 31173: 0 2166: 0 24241: 0 Primary Outcome: Number (%) of subjects with MSC* throughout the entire study period (Total Vaccinated Cohort) MSCs HPV Group HPV Co-adm Group Control Group N = 26679 N = 2166 N = 19921 Subjects with any MSC(s), n (%) 6658 (25.0) 441 (20.4) 5630 (28.3) Gynaecological chlamydia infection 1038 (3.9) 1085 (5.4) Depression 282 (1.1) 233 (1.2) Bronchitis 182 (0.7) 22 (1.0) 128 (0.6) Headache 166 (0.6) 15 (0.7) 114 (0.6) Abdominal pain 155 (0.6) Back pain 148 (0.6) 90 (0.5) Malaria 146 (0.5) 94 (0.5) Genitourinary tract gonococcal infection 142 (0.5) 156 (0.8) Migraine 125 (0.5) 100 (0.5) Gastritis 111 (0.4) Pharyngitis streptococcal 25 (1.2) Oropharyngeal pain 21 (1.0) Otitis media 20 (0.9) Viral infection 20 (0.9) Pyrexia 12 (0.6) Cystitis 12 (0.6) Influenza 12 (0.6) 93 (0.5) Acne 12 (0.6) Genital herpes 104 (0.5) Uterine leiomyoma 90 (0.5) Counting rule applied: As there were more than 30 subjects per treatment group and ≤ 3 groups, only the 10 most frequent events in each treatment group are to be listed. -: Implies that adverse event was not reported in the particular group or that the adverse event was reported in the particular group but did not fall within the pre-defined counting rule of 10 most frequent events for that group *MSCs still blinded are not presented in this document since this study is ongoing Primary Outcome: Number (%) of subjects with pIMDs* throughout the entire study period (Total Vaccinated Cohort) pIMDS HPV HPV Co-adm Control Group Group Group
N = 27353 N = 2166 N = 20504 Subjects with any pIMD(s), n (%) 143 (0.5) 4 (0.2) 112 (0.5) Grave’s or basedow’s disease 9 (0.0) 1 (0.0) 7 (0.0) Psoriasis 16 (0.1) 1 (0.0) 13 (0.1) Cranial nerve disorders 18 (0.1) 1 (0.0) 13 (0.1) Rheumatoid arthropathies 15 (0.1) 9 (0.0) Autoimmune/ hashimoto’s thyroiditis 13 (0.0) 9 (0.0) Celiac disease 7 (0.0) 8 (0.0) Stevens-Johnson syndrome 1 (0.0) Multiple sclerosis 8 (0.0) Vasculitis and vasculitides 8 (0.0) 6 (0.0) Ulcerative colitis 6 (0.0) 5 (0.0) Neuritis 4 (0.0) 7 (0.0) Vitiligo 4 (0.0) Crohn’s disease 7 (0.0) Counting rule applied: As there were more than 30 subjects per treatment group and ≤ 3 groups, only the 10 most frequent events in each treatment group are to be listed. -: Implies that adverse event was not reported in the particular group or that the adverse event was reported in the particular group but did not fall within the pre-defined counting rule of 10 most frequent events for that group *pIMDs still blinded are not presented in this document since this study is ongoing Primary Outcome: Number of pregnancies during the entire study period by nearest dose to pregnancy onset (Total Vaccinated Cohort) HPV Group HPV-Co Adm Group Control Group N = 5377 N = 10 N = 5089 Nearest dose to PO n % n % n % Dose 1 293 5.45 1 10.00 284 5.58 Dose 2 651 12.11 3 30.00 592 11.63 Dose 3 4367 81.22 4 40.00 4164 81.82 Dose 4 66 1.23 2 20.00 49 0.96 PO = Pregnancy onset (=LMP+14 days) N = number of pregnancies n (percentage) = number (percentage) of pregnancies in a given category Primary Outcome: Pregnancy outcomes over the total number of pregnancies with LMP during the entire study period (Total Vaccinated Cohort) Outcome HPV HPV-Co-Adm Group Control Group N = 10 Group N = 5377 N = 5089 n % n % n % Live infant NO apparent congenital anomaly 3956 73.57 4 40.00 3783 74.34 Live infant congenital anomaly 70 1.30 0 0.00 66 1.30 Premature live infant NO apparent congenital anomaly 156 2.90 1 10.00 150 2.95 Premature live infant congenital anomaly 16 0.30 0 0.00 13 0.26 Elective termination NO apparent congenital anomaly 335 6.23 2 20.00 340 6.68 Elective termination congenital anomaly 3 0.06 0 0.00 4 0.08 Therapeutic abortion 4 0.07 0 0.00 3 0.06 Ectopic pregnancy 39 0.73 0 0.00 33 0.65 Spontaneous abortion NO apparent congenital anomaly 623 11.59 1 10.00 554 10.89 Spontaneous abortion congenital anomaly 5 0.09 0 0.00 3 0.06 Stillbirth NO apparent congenital anomaly 30 0.56 0 0.00 31 0.61 Stillbirth congenital anomaly 3 0.06 0 0.00 1 0.02 Lost to follow up 47 0.87 2 20.00 49 0.96 Molar pregnancy 5 0.09 0 0.00 3 0.06 Pregnancy ongoing 85 1.58 0 0.00 56 1.10 Pregnancy onset (=LMP+14 days) LMP= Last Menstrual Period
N = number of pregnancies (with LMP during entire study period) n (percentage) = number (percentage) of pregnancies in a given category Safety Results: Number (%) of subjects with unsolicited AEs* within the 30-day period (Days 0-29) following any vaccination (Total Vaccinated Cohort) Most frequent adverse events - On-Therapy HPV Group HPV Co-adm Group Control Group (occurring within Days 0-29 following vaccination) N = 25697 N = 2166 N = 20474 Subjects with any AE(s), n (%) 7902 (30.8) 1041 (48.1) 6082 (29.7) Subjects with grade 3** AE(s), n (%) 901 (3.5) 144 (6.6) 684 (3.3) Subjects with related*** AE(s), n (%) 1576 (6.1) 345 (15.9) 895 (4.4) Upper respiratory tract infection 813 (3.2) 77 (3.6) 698 (3.4) Nasopharyngitis 800 (3.1) 112 (5.2) 604 (3.0) Headache 819 (3.2) 131 (6.0) 706 (3.4) Oropharyngeal pain 396 (1.5) 92 (4.2) 236 (1.2) Gynaecological chlamydia infection 444 (1.7) 442 (2.2) Influenza 338 (1.3) 291 (1.4) Injection site haematoma 174 (8.0) Dysmenorrhoea 315 (1.2) 63 (2.9) 235 (1.1) Dizziness 296 (1.2) 35 (1.6) 229 (1.1) Injection site pruritus 287 (1.1) Pharyngitis 274 (1.1) 206 (1.0) Cough 56 (2.6) Sinusitis 40 (1.8) Nasal congestion 33 (1.5) Vaginal infection 180 (0.9) Counting rule applied: As there were more than 30 subjects per treatment group and ≤ 3 groups, only the 10 most frequent events in each treatment group are to be listed. -: Implies that adverse event was not reported in the particular group or that the adverse event was reported in the particular group but did not fall within the pre-defined counting rule of 10 most frequent events for that group *Unsolicited adverse events still blinded are not presented in this document since this study is ongoing **Grade 3 AE: AE that prevented normal activity ***Related AE: AE assessed by the investigator to be causally related to the study vaccination Safety Results: Percentage of subjects£ reporting the occurrence of SAEs during the entire study period (Total Vaccinated Cohort) Serious adverse event, n (%) [n considered by the investigator to be related to study medication] All SAEs HPV Group HPV Co-admin Control Group N=31173 Group N=24241 N=2166 Subjects with any SAE(s), n (%) [n assessed by the investigator 2448 (7.9) [71] 29 (1.3) [3] 2244 (9.3) [54] as related] Abortion spontaneous incomplete 227 (0.7) [18] 0 (0.0) [0] 169 (0.7) [7] Abortion spontaneous complete 129 (0.4) [12] 2 (0.1) [0] 124 (0.5) [13] Appendicitis 105 (0.3) [*1*] 5 (0.2) [*1*] 111 (0.5) [*1*] Abortion spontaneous 115 (0.4) [6] 0 (0.0) [0] 103 (0.4) [6] Arrested labour 66 (0.2) [0] 0 (0.0) [0] 72 (0.3) [0] Abortion missed 64 (0.2) [6] 0 (0.0) [0] 68 (0.3) [5] Intra-uterine death 61 (0.2) [3] 0 (0.0) [0] 69 (0.3) [2] Caesarean section 59 (0.2) [0] 0 (0.0) [0] 66 (0.3) [0] Dengue fever 55 (0.2) [0] 0 (0.0) [0] 54 (0.2) [0] Premature labour 51 (0.2) [*1*] 0 (0.0) [*1*] 57 (0.2) [*1*] Foetal distress syndrome 54 (0.2) [*1*] 0 (0.0) [*1*] 53 (0.2) [*1*] Gestational hypertension 43 (0.1) [0] 0 (0.0) [0] 58 (0.2) [0] Abortion threatened 52 (0.2) [*5*] 0 (0.0) [*5*] 47 (0.2) [*5*] Urinary tract infection 40 (0.1) [0] 1 (0.0) [0] 44 (0.2) [0] Cholelithiasis 47 (0.2) [0] 0 (0.0) [0] 37 (0.2) [0] Pre-eclampsia 40 (0.1) [*1*] 0 (0.0) [*1*] 40 (0.2) [*1*]
Breech presentation Cephalo-pelvic disproportion Threatened labour Suicide attempt Ectopic pregnancy Depression Blighted ovum Cholecystitis Abdominal pain Ovarian cyst Pyelonephritis Gastroenteritis Uterine leiomyoma Pyelonephritis acute Failed induction of labour Pneumonia Premature rupture of membranes Road traffic accident Anaemia of pregnancy Pelvic inflammatory disease Ovarian cyst ruptured Stillbirth Tonsillitis Anaemia False labour Premature delivery Premature separation of placenta Gastritis Endometriosis Ligament rupture Malaria Concussion Hyperemesis gravidarum Oligohydramnios Placental insufficiency Abortion induced Asthma Infectious mononucleosis Acute tonsillitis Cellulitis Hypertension Ankle fracture Migraine Multiple injuries Peritonsillar abscess Cholecystitis acute Dysfunctional uterine bleeding Foetal growth restriction Placenta praevia Post procedural haemorrhage Gestational diabetes Postoperative wound infection Postpartum haemorrhage Retained placenta or membranes Back pain Endometritis decidual
42 (0.1) [0] 32 (0.1) [0] 30 (0.1) [4] 39 (0.1) [0] 32 (0.1) [0] 33 (0.1) [0] 32 (0.1) [0] 31 (0.1) [0] 34 (0.1) [0] 28 (0.1) [0] 32 (0.1) [0] 25 (0.1) [1] 21 (0.1) [0] 26 (0.1) [0] 21 (0.1) [0] 26 (0.1) [0] 17 (0.1) [*1*] 18 (0.1) [0] 15 (0.0) [0] 22 (0.1) [0] 12 (0.0) [0] 16 (0.1) [0] 15 (0.0) [0] 12 (0.0) [0] 12 (0.0) [0] 14 (0.0) [*1*] 12 (0.0) [*1*] 13 (0.0) [0] 9 (0.0) [0] 8 (0.0) [0] 11 (0.0) [0] 9 (0.0) [0] 8 (0.0) [*1*] 11 (0.0) [0] 10 (0.0) [0] 12 (0.0) [0] 11 (0.0) [0] 9 (0.0) [0] 9 (0.0) [0] 5 (0.0) [0] 10 (0.0) [0] 6 (0.0) [0] 13 (0.0) [*1*] 9 (0.0) [0] 8 (0.0) [0] 11 (0.0) [0] 8 (0.0) [0] 10 (0.0) [0] 8 (0.0) [0] 7 (0.0) [0] 8 (0.0) [0] 7 (0.0) [0] 9 (0.0) [0] 12 (0.0) [0] 9 (0.0) [0] 7 (0.0) [0]
0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 1 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 1 (0.0) [0] 2 (0.1) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [*1*] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [*1*] 0 (0.0) [*1*] 0 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 0 (0.0) [0] 1 (0.0) [0] 0 (0.0) [*1*] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [*1*] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0]
37 (0.2) [0] 42 (0.2) [0] 41 (0.2) [1] 31 (0.1) [0] 30 (0.1) [0] 26 (0.1) [0] 26 (0.1) [0] 27 (0.1) [0] 19 (0.1) [0] 21 (0.1) [0] 17 (0.1) [0] 20 (0.1) [1] 20 (0.1) [0] 14 (0.1) [0] 18 (0.1) [0] 13 (0.1) [0] 19 (0.1) [*1*] 16 (0.1) [0] 16 (0.1) [0] 9 (0.0) [0] 16 (0.1) [0] 10 (0.0) [0] 10 (0.0) [0] 12 (0.0) [0] 12 (0.0) [0] 10 (0.0) [*1*] 12 (0.0) [*1*] 9 (0.0) [0] 11 (0.0) [0] 12 (0.0) [0] 10 (0.0) [0] 10 (0.0) [0] 12 (0.0) [*1*] 9 (0.0) [0] 10 (0.0) [0] 7 (0.0) [0] 8 (0.0) [0] 10 (0.0) [0] 9 (0.0) [0] 13 (0.1) [0] 8 (0.0) [0] 11 (0.0) [0] 4 (0.0) [*1*] 8 (0.0) [0] 9 (0.0) [0] 5 (0.0) [0] 8 (0.0) [0] 6 (0.0) [0] 8 (0.0) [0] 9 (0.0) [0] 7 (0.0) [0] 8 (0.0) [0] 6 (0.0) [0] 3 (0.0) [0] 5 (0.0) [0] 7 (0.0) [0]
Ovarian germ cell teratoma benign Pancreatitis acute Pyrexia Ruptured ectopic pregnancy Teratoma Cholecystitis chronic Chronic tonsillitis Dehydration Headache Intervertebral disc protrusion Major depression Nephrolithiasis Wound sepsis Abdominal pain lower Bipolar disorder Breast cancer Bronchitis Bronchopneumonia Completed suicide Convulsion Head injury Irritable bowel syndrome Overdose Premature baby Tibia fracture Abdominal pain upper Appendicitis perforated Chorioamnionitis Foot fracture Haemorrhagic ovarian cyst Joint dislocation Constipation Contusion Eclampsia Hypersensitivity Lymphadenitis Ovarian cyst torsion Puerperal pyrexia Thyroid cancer Upper respiratory tract infection Uterine polyp Bradycardia foetal Diarrhoea Epilepsy Foetal macrosomia Gastroenteritis viral Gastrooesophageal reflux disease Humerus fracture Menorrhagia Multiple fractures Ovarian adenoma Psychotic disorder Pulmonary embolism Syncope Traumatic brain injury Viral infection
7 (0.0) [0] 8 (0.0) [0] 9 (0.0) [1] 8 (0.0) [0] 9 (0.0) [0] 8 (0.0) [0] 3 (0.0) [0] 8 (0.0) [0] 9 (0.0) [*1*] 6 (0.0) [0] 5 (0.0) [*1*] 8 (0.0) [0] 6 (0.0) [0] 6 (0.0) [0] 4 (0.0) [0] 8 (0.0) [0] 7 (0.0) [0] 5 (0.0) [0] 5 (0.0) [0] 6 (0.0) [0] 6 (0.0) [0] 6 (0.0) [0] 5 (0.0) [0] 4 (0.0) [*1*] 5 (0.0) [0] 4 (0.0) [0] 6 (0.0) [0] 6 (0.0) [0] 5 (0.0) [0] 5 (0.0) [0] 3 (0.0) [0] 6 (0.0) [0] 5 (0.0) [0] 4 (0.0) [0] 4 (0.0) [0] 6 (0.0) [0] 5 (0.0) [0] 7 (0.0) [0] 4 (0.0) [0] 5 (0.0) [0] 4 (0.0) [0] 2 (0.0) [0] 6 (0.0) [*1*] 3 (0.0) [*1*] 4 (0.0) [0] 3 (0.0) [0] 5 (0.0) [0] 7 (0.0) [0] 4 (0.0) [0] 4 (0.0) [0] 3 (0.0) [0] 4 (0.0) [0] 6 (0.0) [0] 4 (0.0) [0] 4 (0.0) [0] 3 (0.0) [*1*]
0 (0.0) [0] 0 (0.0) [0] 1 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [*1*] 0 (0.0) [0] 0 (0.0) [*1*] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 1 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [*1*] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [*1*] 1 (0.0) [*1*] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 1 (0.0) [0] 1 (0.0) [*1*]
7 (0.0) [0] 6 (0.0) [0] 4 (0.0) [1] 6 (0.0) [0] 5 (0.0) [0] 5 (0.0) [0] 9 (0.0) [0] 4 (0.0) [0] 3 (0.0) [*1*] 6 (0.0) [0] 7 (0.0) [*1*] 4 (0.0) [0] 6 (0.0) [0] 5 (0.0) [0] 6 (0.0) [0] 3 (0.0) [0] 4 (0.0) [0] 6 (0.0) [0] 6 (0.0) [0] 5 (0.0) [0] 5 (0.0) [0] 5 (0.0) [0] 6 (0.0) [0] 7 (0.0) [*1*] 6 (0.0) [0] 6 (0.0) [0] 4 (0.0) [0] 4 (0.0) [0] 5 (0.0) [0] 5 (0.0) [0] 7 (0.0) [0] 3 (0.0) [0] 4 (0.0) [0] 5 (0.0) [0] 5 (0.0) [0] 3 (0.0) [0] 4 (0.0) [0] 2 (0.0) [0] 5 (0.0) [0] 4 (0.0) [0] 5 (0.0) [0] 6 (0.0) [0] 2 (0.0) [*1*] 4 (0.0) [*1*] 4 (0.0) [0] 5 (0.0) [0] 3 (0.0) [0] 1 (0.0) [0] 4 (0.0) [0] 4 (0.0) [0] 5 (0.0) [0] 4 (0.0) [0] 2 (0.0) [0] 4 (0.0) [0] 3 (0.0) [0] 4 (0.0) [*1*]
Wrist fracture Abdominal wall abscess Anorexia nervosa Basedow’s disease Benign hydatidiform mole Drug dependence Metrorrhagia Multiple sclerosis Pelvic pain Post procedural infection Radius fracture Salpingitis Sinusitis Supraventricular tachycardia Urticaria Alcohol poisoning Anaphylactic reaction Asthmatic crisis Bile duct stone Calculus ureteric Cervical dysplasia Clavicle fracture Colitis Deep vein thrombosis Foetal hypokinesia Genital herpes Mastitis Meningitis viral Pancreatitis Pneumonia bacterial Pneumothorax Post procedural haematoma Pulmonary tuberculosis Suicidal ideation Thermal burn Transverse presentation Twin pregnancy Vaginal haemorrhage Abortion infected Abscess limb Bartholin’s abscess Bartholin’s cyst Bartholinitis Breast abscess Breast cancer in situ Cerebrovascular accident Colitis ulcerative Crohn’s disease Dysmenorrhoea Erysipelas Fibula fracture Goitre Hellp syndrome Haemorrhoids Hand fracture Homicide
2 (0.0) [0] 3 (0.0) [0] 5 (0.0) [0] 6 (0.0) [*1*] 4 (0.0) [0] 4 (0.0) [0] 4 (0.0) [*1*] 5 (0.0) [0] 4 (0.0) [0] 3 (0.0) [0] 3 (0.0) [0] 3 (0.0) [0] 5 (0.0) [0] 5 (0.0) [0] 3 (0.0) [0] 4 (0.0) [0] *6* [*3*] 5 (0.0) [0] 4 (0.0) [0] 3 (0.0) [0] 4 (0.0) [0] 4 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0] 5 (0.0) [0] 5 (0.0) [0] 3 (0.0) [0] 5 (0.0) [0] 3 (0.0) [0] 3 (0.0) [0] 2 (0.0) [0] 4 (0.0) [0] 4 (0.0) [0] 2 (0.0) [0] 4 (0.0) [0] 3 (0.0) [0] 5 (0.0) [0] 3 (0.0) [0] 2 (0.0) [*1*] 4 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0] 3 (0.0) [0] 3 (0.0) [0] 1 (0.0) [0] 3 (0.0) [0] 2 (0.0) [*1*] 2 (0.0) [*1*] 3 (0.0) [0] 3 (0.0) [0] *5* [0] 3 (0.0) [0] 4 (0.0) [0] 4 (0.0) [0] 2 (0.0) [0] 3 (0.0) [0]
0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 1 (0.0) [*1*] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [*1*] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] *6* [*3*] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 1 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [*1*] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [*1*] 0 (0.0) [*1*] 0 (0.0) [0] 0 (0.0) [0] *5* [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0]
6 (0.0) [0] 4 (0.0) [0] 2 (0.0) [0] 0 (0.0) [*1*] 3 (0.0) [0] 3 (0.0) [0] 3 (0.0) [*1*] 2 (0.0) [0] 3 (0.0) [0] 4 (0.0) [0] 4 (0.0) [0] 4 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0] 4 (0.0) [0] 2 (0.0) [0] *6* [*3*] 1 (0.0) [0] 2 (0.0) [0] 3 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0] 4 (0.0) [0] 4 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 3 (0.0) [0] 1 (0.0) [0] 3 (0.0) [0] 3 (0.0) [0] 4 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0] 3 (0.0) [0] 2 (0.0) [0] 3 (0.0) [0] 1 (0.0) [0] 3 (0.0) [0] 3 (0.0) [*1*] 1 (0.0) [0] 3 (0.0) [0] 3 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0] 4 (0.0) [0] 2 (0.0) [0] 3 (0.0) [*1*] 3 (0.0) [*1*] 2 (0.0) [0] 2 (0.0) [0] *5* [0] 2 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 3 (0.0) [0] 2 (0.0) [0]
Infection Injury Loss of consciousness Lower limb fracture Meniscus lesion Muscle strain Optic neuritis Osteoarthritis Panic disorder Pharyngitis Pilonidal cyst Systemic lupus erythematosus Tachycardia foetal Tooth abscess Type 2 diabetes mellitus Ulna fracture Upper limb fracture Vertigo Vomiting Abortion incomplete Abscess Anxiety Bipolar i disorder Brain contusion Bronchospasm Calculus urinary Complication of delivery Conversion disorder Cyst Diverticulitis Dizziness Drug hypersensitivity Duodenal ulcer Dyspepsia Dyspnoea Femur fracture Fibroadenoma of breast Food allergy Hiatus hernia Ileus paralytic Limb injury Lumbar vertebral fracture Malignant melanoma Nasal septum deviation Obesity Peritonitis Pleural effusion Pneumonia mycoplasmal Polycystic ovaries Procedural pain Prolonged labour Retained products of conception Rheumatoid arthritis Skull fracture Spinal compression fracture Staphylococcal infection
*5* [0] 3 (0.0) [0] 2 (0.0) [0] 1 (0.0) [0] *5* [0] 3 (0.0) [0] 4 (0.0) [*1*] 1 (0.0) [0] 4 (0.0) [0] 3 (0.0) [0] 3 (0.0) [0] *5* [0] 1 (0.0) [0] 3 (0.0) [0] *5* [*1*] 3 (0.0) [0] 3 (0.0) [0] 3 (0.0) [0] 3 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 2 (0.0) [0] 3 (0.0) [0] 3 (0.0) [0] 1 (0.0) [0] *4* [0] 2 (0.0) [0] 1 (0.0) [0] 2 (0.0) [0] 3 (0.0) [0] 1 (0.0) [0] *4* [0] 2 (0.0) [0] 3 (0.0) [0] 3 (0.0) [0] *4* [0] 2 (0.0) [0] 1 (0.0) [0] 3 (0.0) [0] 2 (0.0) [0] 1 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0] 1 (0.0) [0] 3 (0.0) [0] 3 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0] 2 (0.0) [*1*] 2 (0.0) [0] 2 (0.0) [0] 1 (0.0) [0]
*5* [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] *5* [0] 0 (0.0) [0] 0 (0.0) [*1*] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] *5* [0] 0 (0.0) [0] 0 (0.0) [0] *5* [*1*] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] *4* [0] 1 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 1 (0.0) [0] *4* [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] *4* [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [*1*] 0 (0.0) [0] 0 (0.0) [0] 1 (0.0) [0]
*5* [0] 2 (0.0) [0] 3 (0.0) [0] 4 (0.0) [0] *5* [0] 2 (0.0) [0] 1 (0.0) [*1*] 4 (0.0) [0] 1 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0] *5* [0] 4 (0.0) [0] 2 (0.0) [0] *5* [*1*] 2 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0] 3 (0.0) [0] 3 (0.0) [0] 3 (0.0) [0] 2 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 3 (0.0) [0] *4* [0] 1 (0.0) [0] 3 (0.0) [0] 2 (0.0) [0] 1 (0.0) [0] 2 (0.0) [0] *4* [0] 2 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] *4* [0] 2 (0.0) [0] 3 (0.0) [0] 1 (0.0) [0] 2 (0.0) [0] 3 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0] 3 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 3 (0.0) [0] 3 (0.0) [0] 3 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0] 2 (0.0) [*1*] 2 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0]
Thrombocytopenia Thyroid neoplasm Tooth impacted Tubo-ovarian abscess Typhoid fever Umbilical cord around neck Urosepsis Uterine haematoma Viith nerve paralysis Vaginal discharge Varicose vein Vomiting in pregnancy Abdominal injury Abortion complete Acquired immunodeficiency syndrome Acute psychosis Aggression Alcoholism Arrhythmia Autoimmune thyroiditis Basal cell carcinoma Calculus bladder Cardio-respiratory arrest Cerebral haemorrhage Cervicitis Chest pain Chronic sinusitis Circulatory collapse Depression suicidal Diabetes mellitus inadequate control Drug abuse Endometritis Escherichia urinary tract infection Facial bones fracture Fallopian tube cyst Foot deformity Grand mal convulsion Gun shot wound Hypokalaemia Ileus Jaw fracture Laceration Meningitis tuberculous Menstrual disorder Migraine with aura Muscle rupture Nausea Neonatal hypoxia Ovarian torsion Peritonsillitis Pneumonia primary atypical Post abortion infection Post-traumatic stress disorder Presyncope Renal colic Schizophrenia
1 (0.0) [*1*] 3 (0.0) [0] 2 (0.0) [0] 3 (0.0) [0] *4* [0] 3 (0.0) [0] 2 (0.0) [0] 3 (0.0) [0] 2 (0.0) [*1*] 3 (0.0) [0] 2 (0.0) [0] 3 (0.0) [0] 1 (0.0) [0] 2 (0.0) [0] 1 (0.0) [0] 2 (0.0) [0] 1 (0.0) [0] 2 (0.0) [0] *3* [0] 2 (0.0) [0] 2 (0.0) [0] *3* [0] *3* [0] 2 (0.0) [0] 2 (0.0) [0] *3* [0] *3* [0] *3* [0] 1 (0.0) [0] 1 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] *3* [0] *3* [0] *3* [*2*] *3* [0] 1 (0.0) [0] *3* [0] *3* [0] 2 (0.0) [0] *3* [0] 1 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0] *3* [0] 1 (0.0) [0] *3* [0] 1 (0.0) [0] *3* [0] 1 (0.0) [0] 2 (0.0) [0] 2 (0.0) [*1*] 2 (0.0) [0] 1 (0.0) [0]
0 (0.0) [*1*] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] *4* [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 1 (0.0) [*1*] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] *3* [0] 0 (0.0) [0] 0 (0.0) [0] *3* [0] *3* [0] 0 (0.0) [0] 0 (0.0) [0] *3* [0] *3* [0] *3* [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] *3* [0] *3* [0] *3* [*2*] *3* [0] 0 (0.0) [0] *3* [0] *3* [0] 0 (0.0) [0] *3* [0] 0 (0.0) [0] 0 (0.0) [0] 1 (0.0) [0] *3* [0] 0 (0.0) [0] *3* [0] 0 (0.0) [0] *3* [0] 0 (0.0) [0] 0 (0.0) [0] 1 (0.0) [*1*] 0 (0.0) [0] 0 (0.0) [0]
3 (0.0) [*1*] 1 (0.0) [0] 2 (0.0) [0] 1 (0.0) [0] *4* [0] 1 (0.0) [0] 2 (0.0) [0] 1 (0.0) [0] 1 (0.0) [*1*] 1 (0.0) [0] 2 (0.0) [0] 1 (0.0) [0] 2 (0.0) [0] 1 (0.0) [0] 2 (0.0) [0] 1 (0.0) [0] 2 (0.0) [0] 1 (0.0) [0] *3* [0] 1 (0.0) [0] 1 (0.0) [0] *3* [0] *3* [0] 1 (0.0) [0] 1 (0.0) [0] *3* [0] *3* [0] *3* [0] 2 (0.0) [0] 2 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0] *3* [0] *3* [0] *3* [*2*] *3* [0] 2 (0.0) [0] *3* [0] *3* [0] 1 (0.0) [0] *3* [0] 2 (0.0) [0] 1 (0.0) [0] 0 (0.0) [0] *3* [0] 2 (0.0) [0] *3* [0] 2 (0.0) [0] *3* [0] 2 (0.0) [0] 1 (0.0) [0] 0 (0.0) [*1*] 1 (0.0) [0] 2 (0.0) [0]
Sepsis Sinus tachycardia Snake bite Splenic rupture Subarachnoid haemorrhage Subcutaneous abscess Synovitis Tendon injury Tendon rupture Tension headache Tonsillar hypertrophy Type 1 diabetes mellitus Umbilical hernia Varicella Wound Abnormal behaviour Abortion induced incomplete Accidental overdose Acute myocardial infarction Acute sinusitis Adenomyosis Adnexa uteri cyst Anal abscess Anaphylactic shock Angina unstable Animal bite Anogenital warts Antepartum haemorrhage Appendiceal abscess Appendix disorder Arthritis reactive Bacterial infection Benign ovarian tumour Beta haemolytic streptococcal infection Biliary tract disorder Bone cyst Bone fissure Brain injury Breast cancer female Breast cyst Breast hyperplasia Bronchogenic cyst Bulimia nervosa Burn infection Burns third degree Comminuted fracture Cyclic vomiting syndrome Cystitis Decreased appetite Diabetic ketoacidosis Diarrhoea infectious Ear infection Eating disorder Ectopic pregnancy with intrauterine device Enteritis Enteritis infectious
2 (0.0) [0] 2 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 2 (0.0) [0] *3* [0] 1 (0.0) [0] *3* [0] *3* [0] *3* [0] 1 (0.0) [0] 2 (0.0) [0] *3* [0] 1 (0.0) [0] *3* [0] *2* [0] *2* [0] *2* [0] *2* [0] *2* [0] *2* [0] 1 (0.0) [0] *2* [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] *2* [*1*] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] *2* [0] *2* [0] *2* [0] *2* [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] *2* [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0]
0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] *3* [0] 0 (0.0) [0] *3* [0] *3* [0] *3* [0] 0 (0.0) [0] 0 (0.0) [0] *3* [0] 0 (0.0) [0] *3* [0] *2* [0] *2* [0] *2* [0] *2* [0] *2* [0] *2* [0] 0 (0.0) [0] *2* [0] *2* [0] 0 (0.0) [0] 0 (0.0) [0] *2* [0] 0 (0.0) [0] 0 (0.0) [0] *2* [0] *2* [*1*] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] *2* [0] 0 (0.0) [0] *2* [0] 0 (0.0) [0] 0 (0.0) [0] *2* [0] *2* [0] *2* [0] *2* [0] *2* [0] 0 (0.0) [0] *2* [0] 0 (0.0) [0] *2* [0] 0 (0.0) [0] *2* [0] *2* [0] 0 (0.0) [0] 0 (0.0) [0] *2* [0]
1 (0.0) [0] 1 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0] 1 (0.0) [0] *3* [0] 2 (0.0) [0] *3* [0] *3* [0] *3* [0] 2 (0.0) [0] 1 (0.0) [0] *3* [0] 2 (0.0) [0] *3* [0] *2* [0] *2* [0] *2* [0] *2* [0] *2* [0] *2* [0] 1 (0.0) [0] *2* [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] *2* [*1*] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] *2* [0] *2* [0] *2* [0] *2* [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] *2* [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0]
Enterocolitis Epidemic nephropathy Epstein-barr virus infection Essential hypertension Excoriation Eye injury Face presentation Fatigue Foetal malpresentation Food poisoning Foreign body Gastric ulcer Gastritis erosive Gastrointestinal disorder Genital discharge Gestational trophoblastic tumour Gynaecological chlamydia infection Haematemesis Henoch-schonlein purpura Hepatitis a Hepatitis c Hepatitis acute Hip fracture Hydrocephalus Hydronephrosis Hypertensive crisis Ileitis Imminent abortion Incisional hernia Inguinal hernia Injury associated with device Intentional self-injury Intestinal obstruction Intracranial aneurysm Iron deficiency anaemia Kidney infection Liver disorder Lobar pneumonia Lower respiratory tract infection Malocclusion Meconium in amniotic fluid Myocarditis Nasal turbinate hypertrophy Nasopharyngitis Neutropenia Oesophagitis Osteomyelitis Ovarian cancer Ovarian neoplasm Pain Pain in extremity Paraesthesia Parotitis Parovarian cyst Pelvic fracture Pericarditis
*2* [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] *2* [0] 1 (0.0) [*1*] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] *2* [0] *2* [*1*] 1 (0.0) [0] 1 (0.0) [0] *2* [0] *2* [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] 0 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] *2* [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 0 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] *2* [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0]
*2* [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] *2* [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] *2* [0] *2* [0] 0 (0.0) [*1*] *2* [0] 0 (0.0) [0] 0 (0.0) [0] *2* [0] *2* [0] *2* [*1*] 0 (0.0) [0] 0 (0.0) [0] *2* [0] *2* [0] *2* [0] 0 (0.0) [0] 0 (0.0) [0] 1 (0.0) [0] 0 (0.0) [0] *2* [0] 0 (0.0) [0] 0 (0.0) [0] *2* [0] 0 (0.0) [0] 0 (0.0) [0] *2* [0] *2* [0] *2* [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 1 (0.0) [0] 0 (0.0) [0] *2* [0] 0 (0.0) [0] *2* [0] *2* [0] 0 (0.0) [0] 0 (0.0) [0] *2* [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0]
*2* [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] *2* [0] 1 (0.0) [*1*] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] *2* [0] *2* [*1*] 1 (0.0) [0] 1 (0.0) [0] *2* [0] *2* [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] *2* [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] *2* [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0]
Pharyngeal abscess Pituitary tumour benign Placenta accreta Polyhydramnios Post lumbar puncture syndrome Postoperative abscess Postpartum depression Pyloric stenosis Pyoderma Renal failure acute Retinal detachment Retroplacental haematoma Rhinitis Rib fracture Salmonellosis Salpingo-oophoritis Sinus bradycardia Sleep apnoea syndrome Soft tissue injury Staphylococcal abscess Status asthmaticus Stevens-johnson syndrome Strabismus Synovial cyst Teratoma benign Thrombosis Tonsillitis bacterial Tonsillitis streptococcal Tooth infection Tooth malformation Toxicity to various agents Tuberculosis Tympanic membrane perforation Ulnar nerve injury Umbilical cord prolapse Urinary retention Uterine atony Uterine cyst Uterine haemorrhage Uterine inversion Uterine prolapse Vaginal infection Venous thrombosis limb Vestibular neuronitis Vulvitis Whiplash injury Wolff-parkinson-white syndrome Wound dehiscence Wound infection Abdominal abscess Abdominal adhesions Abdominal hernia Abdominal wall haematoma Abortion Abortion induced complete Abortion induced complete complicated
*2* [0] *2* [0] *2* [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] *2* [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [*1*] 1 (0.0) [0] *2* [0] *2* [0] *2* [0] *2* [0] 0 (0.0) [0] 1 (0.0) [0] *2* [0] *2* [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [*1*] *2* [0] *2* [0] 1 (0.0) [0] *2* [0] *2* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
*2* [0] *2* [0] *2* [0] 0 (0.0) [0] *2* [0] 0 (0.0) [0] *2* [0] 0 (0.0) [0] 0 (0.0) [0] *2* [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] *2* [0] 0 (0.0) [0] *2* [0] 0 (0.0) [0] *2* [0] *2* [0] 0 (0.0) [0] 0 (0.0) [0] 1 (0.0) [*1*] 0 (0.0) [0] *2* [0] *2* [0] *2* [0] *2* [0] 1 (0.0) [0] 0 (0.0) [0] *2* [0] *2* [0] *2* [0] 0 (0.0) [0] 0 (0.0) [0] *2* [0] 0 (0.0) [0] 0 (0.0) [0] *2* [0] *2* [0] 0 (0.0) [0] 0 (0.0) [0] *2* [0] 0 (0.0) [0] 0 (0.0) [*1*] *2* [0] *2* [0] 0 (0.0) [0] *2* [0] *2* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
*2* [0] *2* [0] *2* [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] *2* [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] 0 (0.0) [*1*] 1 (0.0) [0] *2* [0] *2* [0] *2* [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] *2* [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] *2* [0] 1 (0.0) [0] 1 (0.0) [0] *2* [0] 1 (0.0) [0] 1 (0.0) [*1*] *2* [0] *2* [0] 1 (0.0) [0] *2* [0] *2* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
Accident Acrochordon Acute abdomen Acute respiratory failure Addison’s disease Adenocarcinoma Adenocarcinoma of the cervix Adenoma benign Adjustment disorder Adnexa uteri pain Adverse drug reaction Adverse event Alcohol abuse Allergic granulomatous angiitis Altered state of consciousness Amenorrhoea Amoebiasis Amputation Anaemia haemolytic autoimmune Anaesthetic complication Anaesthetic complication pulmonary Anal fissure Anaplastic astrocytoma Angina pectoris Angioedema Angle closure glaucoma Aortic rupture Aphasia Apnoeic attack Arnold-chiari malformation Arterial injury Arterial occlusive disease Arteriosclerosis Artery dissection Arthralgia Arthritis Arthropathy Arthropod bite Arthropod sting Ascites Astrocytoma malignant Astrocytoma, low grade Atrial fibrillation Atrial flutter Atrophy of globe Avulsion fracture Bacterial pyelonephritis Bacterial sepsis Bacterial toxaemia Basal ganglia haemorrhage Basilar artery thrombosis Benign gastric neoplasm Benign intracranial hypertension Biliary cirrhosis Biliary colic Bipolar ii disorder
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
Blindness unilateral Bone sarcoma Bone tuberculosis Borderline personality disorder Breast cancer metastatic Breast cancer stage i Breast cancer stage ii Breast haematoma Breech extraction Bronchiectasis Bronchitis chronic Bronchitis viral Burns first degree Burns second degree Campylobacter gastroenteritis Candida sepsis Carbohydrate intolerance Carbuncle Carcinoid tumour of the appendix Cardiac arrest Cardiac valve disease Cardiopulmonary failure Carotid artery dissection Cartilage injury Cataract Cerebral cyst Cerebral ischaemia Cerebral malaria Cerebral toxoplasmosis Cerebrospinal fistula Cervical conisation Cervical polyp Cervix cancer metastatic Cervix carcinoma Cervix carcinoma stage 0 Chemical poisoning Chlamydial infection Cholestasis Cholestasis of pregnancy Cholesterosis Chondropathy Chronic myeloid leukaemia Clitoris abscess Clostridium difficile colitis Coagulopathy Coarctation of the aorta Coeliac disease Colon cancer Colon injury Colonic pseudo-obstruction Colpocele Complicated migraine Complication of pregnancy Confusional state Congenital anomaly in offspring Congenital cardiovascular anomaly
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
Congestive cardiomyopathy Conjunctivitis Corneal lesion Costochondritis Cubital tunnel syndrome Cystitis klebsiella Cytomegalovirus infection Dacryostenosis acquired Deafness Deafness bilateral Delivery Demyelination Depressed mood Dermatitis Dermatitis atopic Dermoid cyst Device dislocation Device occlusion Diabetes mellitus Diabetic coma Diaphragmatic hernia Diaphragmatic injury Disseminated intravascular coagulation Dissociative disorder Drowning Drug eruption Dysentery Dyspareunia Dysplasia Dysthymic disorder Dystonia Embolic cerebral infarction Emotional distress Endometrial hyperplasia Endosalpingiosis Enterobiasis Enterocolitis infectious Epiglottitis Epiploic appendagitis Epistaxis Erythema multiforme Erythema nodosum Escherichia infection Escherichia sepsis Extrapulmonary tuberculosis Eye infection toxoplasmal Eyeball rupture Facial paresis Faecaloma Faeces hard Failed forceps delivery Fallopian tube abscess Femoral hernia Fibroma Fibromyalgia Fibrosis
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [*1*] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [*1*] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [*1*] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [*1*] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
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Focal nodular hyperplasia Foetal heart rate abnormal Forearm fracture Foreign body reaction Fracture Gait disturbance Gallbladder disorder Gallbladder pain Gallbladder polyp Gastric ulcer perforation Gastroduodenitis Gastroenteritis bacterial Gastroenteritis shigella Gastrointestinal haemorrhage Gastrointestinal infection Gastrointestinal inflammation Generalised anxiety disorder Genital prolapse Genitourinary tract infection Glioblastoma multiforme Glomerulonephritis acute Glomerulonephritis membranoproliferative Groin abscess H1n1 influenza Hiv infection Haematochezia Haematoma Haematoma infection Haematosalpinx Haemorrhage Haemorrhagic fever Heat stroke Helicobacter gastritis Hepatitis Hepatitis alcoholic Hepatitis cholestatic Hernia obstructive Herpangina Herpes oesophagitis Herpes virus infection Herpes zoster Hidradenitis Hip dysplasia Histrionic personality disorder Hodgkin’s disease Hordeolum Hyperchromic anaemia Hyperglycaemia Hypersplenism Hypertensive heart disease Hyperventilation Hyphaema Hypoglycaemia Hyponatraemia Hypotension Hypoxic-ischaemic encephalopathy
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
Idiopathic thrombocytopenic purpura Iga nephropathy Ilium fracture Ill-defined disorder Immunosuppression Impaired gastric emptying Incision site abscess Induced abortion infection Induced labour Infected bites Infection parasitic Inflammatory bowel disease Intentional overdose Interstitial lung disease Intestinal mass Intestinal polyp Intra-abdominal haemorrhage Intracranial haematoma Intracranial pressure increased Intracranial venous sinus thrombosis Intraocular pressure increased Intrapartum haemorrhage Investigation Iris injury Ischaemic stroke Jaundice Joint injury Joint instability Joint range of motion decreased Joint sprain Jugular vein thrombosis Laryngitis Leiomyoma Leukocytosis Ligament disorder Ligament injury Ligament pain Lipoma Liposarcoma Localised infection Long qt syndrome Lower gastrointestinal haemorrhage Ludwig angina Lumbar hernia Lung neoplasm malignant Lupus-like syndrome Lyme disease Lymph node tuberculosis Lymphadenopathy Macular oedema Maculopathy Malignant melanoma stage iv Mania Mastitis postpartum Mastoiditis Mediastinum neoplasm
*1* [0] *1* [*1*] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
*1* [0] *1* [*1*] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
*1* [0] *1* [*1*] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
Medical observation Meniere’s disease Meningioma Meningitis bacterial Meningitis pneumococcal Menometrorrhagia Mental disorder Metastases to lung Metastatic renal cell carcinoma Microcytic anaemia Mitral valve prolapse Monoparesis Mouth cyst Moyamoya disease Multiple congenital abnormalities Multiple myeloma Muscle injury Muscle spasms Musculoskeletal pain Myalgia Myelitis Myofascial pain syndrome Nail operation Nasal cyst Nasal disorder Nasopharyngeal cancer Neoplasm Neoplasm malignant Nephritis Nephrotic syndrome Nerve injury Neuroborreliosis Neurocysticercosis Neuropathy peripheral Neuropathy vitamin b6 deficiency Non-hodgkin’s lymphoma Obstructed labour Oedema Oedema peripheral Oedematous pancreatitis Opisthorchiasis Oropharyngeal pain Otitis externa Otitis externa bacterial Otitis media Otitis media acute Ovarian abscess Ovarian adhesion Ovarian dysgerminoma stage unspecified Ovarian epithelial cancer Ovarian failure Ovarian haemorrhage Ovarian mass Pancreatitis chronic Pancreatitis relapsing Panic reaction
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
Paronychia Parotid abscess Pasteurella infection Patella fracture Pathological fracture Pelvic abscess Pelvic infection Pelvic mass Pelvic prolapse Pelvic venous thrombosis Peptic ulcer Perineal laceration Periorbital cellulitis Periostitis Peritoneal infection Peritoneal tuberculosis Peroneal nerve palsy Persecutory delusion Pharyngitis streptococcal Pharyngotonsillitis Physical assault Pituitary tumour Placenta praevia haemorrhage Placental disorder Placental transfusion syndrome Pleocytosis Pneumococcal sepsis Pneumonia aspiration Pneumonia influenzal Pneumonia streptococcal Pneumonia viral Pneumonitis Poisoning Polyarthritis Polymyalgia rheumatica Polyneuropathy Post abortion haemorrhage Post procedural cellulitis Post-traumatic pain Postoperative adhesion Postoperative ileus Postpartum sepsis Postpartum state Postpartum uterine subinvolution Postural orthostatic tachycardia syndrome Proctitis Prolonged pregnancy Pseudocroup Psoriasis Psoriatic arthropathy Pulmonary mass Pulmonary thrombosis Pyoderma gangrenosum Pyomyositis Pyonephrosis Rash pruritic
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [*1*] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [*1*] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [*1*] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
Rectal polyp Reflux gastritis Reflux oesophagitis Renal abscess Renal disorder Renal failure Renal oncocytoma Renal surgery Respiratory failure Respiratory tract infection Retinal vein thrombosis Rhinitis hypertrophic Sacroiliitis Sarcoidosis Scapula fracture Schizophreniform disorder Sciatica Scoliosis Sedation Sexual abuse Sinus disorder Skeletal injury Skin disorder Skin infection Skin necrosis Skull fractured base Small for dates baby Small intestinal obstruction Spinal fracture Splenic infarction Splenomegaly Squamous cell carcinoma Stab wound Staphylococcal sepsis Still’s disease adult onset Streptococcal infection Stress cardiomyopathy Suicidal behaviour Syphilis Tachycardia Tendonitis Tenosynovitis Thoracic vertebral fracture Thyroglossal cyst Thyroid cyst Thyroiditis Tooth ankylosis Tooth disorder Toothache Toxic nodular goitre Tracheitis Transaminases increased Traumatic liver injury Trichomoniasis Trigeminal neuralgia Tumour haemorrhage
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [*1*] *1* [0] *1* [0] *1* [0] *1* [0]
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [*1*] *1* [0] *1* [0] *1* [0] *1* [0]
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [*1*] *1* [0] *1* [0] *1* [0] *1* [0]
Ulcerative keratitis Umbilical cord abnormality Upper gastrointestinal haemorrhage Ureteric obstruction Ureteric stenosis Urinary retention postoperative Urinary tract infection bacterial Urticaria chronic Uterine enlargement Uterine hypertonus Uterine malposition Uterine perforation Uterine rupture Uterovaginal prolapse Vaginal cancer Vaginal prolapse Varicophlebitis Vascular headache Vascular injury Vasculitis Venous injury Venous thrombosis Ventricular arrhythmia Vertigo positional Victim of crime Vision blurred Vulval abscess Vulval cancer Vulval haematoma Vulvovaginal human papilloma virus infection Vulvovaginal injury Vulvovaginitis trichomonal Weight increased Fatal SAEs
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [*1*] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] HPV Group N=31173
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [*1*] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] Control Group N=24241
38 (0.1) [*1*]
*1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [*1*] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] HPV Co-admin Group N=2166 1 (0.0) [*1*]
Subjects with fatal SAE(s), n (%) [n assessed by the investigator as related] Completed suicide Road traffic accident Homicide Suicide attempt Acute myocardial infarction Cardio-respiratory arrest Depression Pulmonary embolism Sepsis Systemic lupus erythematosus Acquired immunodeficiency syndrome Anaphylactic shock Aortic rupture Asthmatic crisis Astrocytoma malignant Bone sarcoma Breast cancer Breast cancer metastatic
5 (0.0) [0] 3 (0.0) [0] 3 (0.0) [0] 2 (0.0) [0] *2* [0] *2* [0] *2* [0] *2* [0] 1 (0.0) [0] *2* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] 0 (0.0) [0] *2* [0] *2* [0] *2* [0] *2* [0] 0 (0.0) [0] *2* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
6 (0.0) [0] 5 (0.0) [0] 2 (0.0) [0] 2 (0.0) [0] *2* [0] *2* [0] *2* [0] *2* [0] 1 (0.0) [0] *2* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0] *1* [0]
24 (0.1) [*1*]
Breast cancer stage ii *1* [0] *1* [0] *1* [0] Bronchopneumonia *1* [0] *1* [0] *1* [0] Candida sepsis *1* [0] *1* [0] *1* [0] Cardiac valve disease *1* [0] *1* [0] *1* [0] Cardiopulmonary failure *1* [0] *1* [0] *1* [0] Cephalo-pelvic disproportion *1* [0] *1* [0] *1* [0] Cervix cancer metastatic *1* [0] *1* [0] *1* [0] Colon cancer *1* [0] *1* [0] *1* [0] Crohn’s disease *1* [*1*] *1* [*1*] *1* [*1*] Deep vein thrombosis *1* [0] *1* [0] *1* [0] Dehydration *1* [0] *1* [0] *1* [0] Diabetic ketoacidosis *1* [0] *1* [0] *1* [0] Diarrhoea *1* [0] *1* [0] *1* [0] Drowning *1* [0] *1* [0] *1* [0] Drug hypersensitivity *1* [0] *1* [0] *1* [0] Gestational trophoblastic tumour *1* [0] *1* [0] *1* [0] Glioblastoma multiforme *1* [0] *1* [0] *1* [0] Gun shot wound *1* [0] *1* [0] *1* [0] Head injury *1* [0] *1* [0] *1* [0] Henoch-schonlein purpura *1* [0] *1* [0] *1* [0] Hydrocephalus *1* [0] *1* [0] *1* [0] Hyponatraemia *1* [0] *1* [0] *1* [0] Inflammatory bowel disease *1* [0] *1* [0] *1* [0] Interstitial lung disease *1* [0] *1* [0] *1* [0] Liver disorder *1* [0] *1* [0] *1* [0] Lower respiratory tract infection *1* [0] *1* [0] *1* [0] Lung neoplasm malignant *1* [0] *1* [0] *1* [0] Meningitis tuberculous *1* [0] *1* [0] *1* [0] Metastases to lung *1* [0] *1* [0] *1* [0] Metastatic renal cell carcinoma *1* [0] *1* [0] *1* [0] Multiple myeloma *1* [0] *1* [0] *1* [0] Myocarditis *1* [0] *1* [0] *1* [0] Nausea *1* [0] *1* [0] *1* [0] Osteomyelitis *1* [0] *1* [0] *1* [0] Ovarian cancer *1* [0] *1* [0] *1* [0] Pneumococcal sepsis *1* [0] *1* [0] *1* [0] Pneumonia primary atypical *1* [0] *1* [0] *1* [0] Pulmonary mass *1* [0] *1* [0] *1* [0] Pyoderma gangrenosum *1* [0] *1* [0] *1* [0] Pyrexia *1* [0] *1* [0] *1* [0] Renal failure acute *1* [0] *1* [0] *1* [0] Skin disorder *1* [0] *1* [0] *1* [0] Splenic rupture *1* [0] *1* [0] *1* [0] Stevens-johnson syndrome *1* [0] *1* [0] *1* [0] Subarachnoid haemorrhage *1* [0] *1* [0] *1* [0] Teratoma benign *1* [0] *1* [0] *1* [0] Traumatic brain injury *1* [0] *1* [0] *1* [0] Victim of crime *1* [0] *1* [0] *1* [0] Vomiting *1* [0] *1* [0] *1* [0] ** = highest n subjects reported at least in one group and none in at least one of the other groups. Those cases remain blinded since the study is ongoing. £SAEs reported by the subjects or their offspring. Conclusion: A total of 57.580 subjects were included in the pooled safety analysis of completed or ongoing studies, of which 33.339 received the selected HPV-16/18 vaccine alone or co-administered with another study vaccine and 24241 received a control vaccine. For the entire study period, at least one MSC was reported by 6658 (25.0%) subjects in the HPV Group, 441 (20.4%)
subjects in the HPV co-admin Group and 5630 (28.3%) subjects in the Control group. During the entire study period, at least one pIMD was reported by 143 (0.5%) in the HPV Group, 4 (0.2%) subjects in the HPV co-admin Group and 112 (0.5%) subjects in the Control Group. A total of 10476 pregnancies were reported during the entire study period (5377 in the HPV Group, 10 in the HPV co-admin Group and 5089 in the Control Group).Pregnancy outcomes were reported during the entire study period. Within 30 days after any vaccine dose, at least one unsolicited AE was reported by 7902 (30.8%) subjects in the HPV Group, 1041 (48.1%) subjects in the HPV co-admin Group and 6082 (29.7%) subjects in the Control Group. During the entire study period, SAEs were reported for subjects or their offspring as follows: at least one SAE was reported by 2448 (7.9%) subjects in the HPV Group, 29 (1.3) in the HPV co-admin Group and 2244 (9.3%) subjects in the Control Group. For the same period, the number of subjects reporting at least one SAE assessed by the investigators as related to the vaccination was 71 in the HPV Group, 3 in the HPV co-admin Group and 54 in the Control Group. Up to 31 April 2011, fatal SAEs were reported for a total of 63 subjects or their offspring, at least one fatal SAE was reported for 38 (0.1%) subjects in the HPV Group, 1 (0.0%) subject in the HPV co-admin Group and 24 (0.1%) subjects in the Control Group. One fatal SAE (Crohn’s disease) was assessed by the investigator as possibly related to vaccination. Publications: Descamps D et al. (2009) Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: A pooled analysis of 11 clinical trials. Hum Vaccin. 5(5):51-59. Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638. Date updated: 10-December-2012
