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Supplementary table 1: Overview of 17 case reports that included the MedDRA PT of CRPS from GSK’s worldwide safety database CountryAge (years)Events (MedDRA Preferred terms)Time to onsetCase OutcomeAssessment of GSKs safety physician using proposed experimental IASP 1999 criteria l ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"2n0jmvghq6","properties":{"formattedCitation":"{\\rtf \\super 29\\nosupersub{}}","plainCitation":"29"},"citationItems":[{"id":4676,"uris":[""],"uri":[""],"itemData":{"id":4676,"type":"article-journal","title":"Complex regional pain syndrome: are the IASP diagnostic criteria valid and sufficiently comprehensive?","container-title":"Pain","page":"211-219","volume":"83","issue":"2","source":"NCBI PubMed","abstract":"This is a multisite study examining the internal validity and comprehensiveness of the International Association for the Study of Pain (IASP) diagnostic criteria for Complex Regional Pain Syndrome (CRPS). A standardized sign/symptom checklist was used in patient evaluations to obtain data on CRPS-related signs and symptoms in a series of 123 patients meeting IASP criteria for CRPS. Principal components factor analysis (PCA) was used to detect statistical groupings of signs/symptoms (factors). CRPS signs and symptoms grouped together statistically in a manner somewhat different than in current IASP/CRPS criteria. As in current criteria, a separate pain/sensation criterion was supported. However, unlike in current criteria, PCA indicated that vasomotor symptoms form a factor distinct from a sudomotor/edema factor. Changes in range of motion, motor dysfunction, and trophic changes, which are not included in the IASP criteria, formed a distinct fourth factor. Scores on the pain/sensation factor correlated positively with pain duration (P<0. 001), but there was a negative correlation between the sudomotor/edema factor scores and pain duration (P<0.05). The motor/trophic factor predicted positive responses to sympathetic block (P<0.05). These results suggest that the internal validity of the IASP/CRPS criteria could be improved by separating vasomotor signs/symptoms (e.g. temperature and skin color asymmetry) from those reflecting sudomotor dysfunction (e.g. sweating changes) and edema. Results also indicate motor and trophic changes may be an important and distinct component of CRPS which is not currently incorporated in the IASP criteria. An experimental revision of CRPS diagnostic criteria for research purposes is proposed. Implications for diagnostic sensitivity and specificity are discussed.","ISSN":"0304-3959","note":"PMID: 10534592","shortTitle":"Complex regional pain syndrome","journalAbbreviation":"Pain","language":"eng","author":[{"family":"Harden","given":"R. N."},{"family":"Bruehl","given":"S."},{"family":"Galer","given":"B. S."},{"family":"Saltz","given":"S."},{"family":"Bertram","given":"M."},{"family":"Backonja","given":"M."},{"family":"Gayles","given":"R."},{"family":"Rudin","given":"N."},{"family":"Bhugra","given":"M. K."},{"family":"Stanton-Hicks","given":"M."}],"issued":{"date-parts":[["1999",11]]},"PMID":"10534592"}}],"schema":""} 29 Assessment by independent expertsUK13 Complex regional pain syndrome, Peripheral coldness, Pallor, Skin discolouration, Oedema peripheral, Pain in extremity1 HourResolvedUnconfirmed case of CRPS due to insufficient evidence to meet diagnostic criteria of CRPS. There was no continuous spontaneous pain, only some pain was reported on movement. The vaccinated arm was pale, cold and swollen; which spontaneously resolved on 3 occasions each lasting no more than 15 minutes during 1st day. The condition completely resolved 7 days Not confirmed as CRPS UK14 Complex regional pain syndrome, Injection site haemorrhage, Hypoaesthesia, Oedema peripheral, Skin discolouration, Peripheral coldness, Muscular weakness, Movement disorder, Idiosyncratic drug reaction0 DaysUnresolvedUnconfirmed case of CRPS due to insufficient evidence to meet diagnostic criteria of CRPS. Reported symptoms included numbness, muscular weakness and swollen fingers. Reflexes were normal and no sensory abnormalities were notedNot confirmed as CRPSUK14 Complex regional pain syndrome, Oedema peripheralSame dayUnresolvedUnconfirmed case of CRPS due to insufficient evidence to meet diagnostic criteria of CRPS. Only reported symptom was hand swellingNot confirmed as CRPS UK14 Complex regional pain syndrome0 DaysResolved with sequelaeFulfils diagnostic criteria for CRPS. Intensepain, increasing in severity, swollen (oedema) arm,sweating, with intermittent cold, warm hand, bluediscolouration and with restricted hand movementConfirmed case of CRPS Japan46 Bursitis, Bone atrophy, Complex regional pain syndrome, Periarthritis, Arthritis, Myositis, Muscular weakness, Musculoskeletal stiffness, Pain in extremity, Injected limb mobility decreased, Arthralgia, Injection site pain, Tendonitis, Injection site movement impairment, Injection site erythema, Injection site swelling, Fluid retention, Musculoskeletal pain, Joint swelling, Polyarthritis, Pain, Synovitis, Rotator cuff syndrome, Synovectomy, Synovial disorder, Inflammation, Excessive granulation tissue, Fibrosis, Red blood cell sedimentation rate increased, C-reactive protein increased, Hyperaesthesia, Temperature regulation disorder, Oedema, Hyperhidrosis, Hypohidrosis, Dystonia, Joint contracture, Soft tissue disorder, Wrong technique in drug usage process0 MonthsResolvedFulfils diagnostic criteria of CRPS. The subject experienced intense persistent pain, inflammation, decreased range of motion. However, vaccine was administered at wrong place, close to acromion and she was concurrently diagnosed with bursitis and synovitis. The events can be considered related to the method of administration (maladministration) Confirmed case of CRPS. Note, that bursitis, due to incorrect injection technique, is an alternative diagnosisJapan13 Complex regional pain syndrome, Middle insomnia, Injection site erythema, Sleep disorder, Complement factor increased, Pain in extremity, Pain, Hyperaesthesia, Arthralgia, Muscle twitching, Ischaemia, Hyperhidrosis, Abdominal pain, Dyspnoea, Flank pain, Abdominal pain upper, Fibromyalgia, Somatoform disorder4 HoursUnknownUnlikely case of CRPS. Paroxysmal pain in different places was reported. No other symptoms of CRPS Somatoform disorder and fibromyalgia were noted as differential diagnosesNot confirmed as CRPSUK10-19 Complex regional pain syndrome, Injection site pain, Injection site swelling, Injection site inflammation, Hypokinesia, Skin discolourationImmediateUnknownUnconfirmed case of CRPS due to insufficient evidence to meet diagnostic criteria of CRPS. There was no continuous spontaneous painNot confirmed as CRPSJapan12 Complex regional pain syndrome, Oedema peripheral, Pain in extremity, Musculoskeletal pain, Hypoaesthesia, Skin discolouration, Peripheral coldness, Movement disorder, Back pain, Pyrexia, Injected limb mobility decreased, Injection site irritation, Pain, Extensive swelling of vaccinated limb, Injection site pain, Gait disturbance, Hyperhidrosis, Diplopia, Allodynia, Swelling, Dysgeusia, Headache, Convulsion, Dyscalculia, Sleep disorder, Abnormal behaviour, Screaming, Platelet count decreased, Dissociation, Myalgia, Arthralgia, Photophobia, Nausea, Anxiety, Pruritus, Rash, Dysphagia, Memory impairment, Vomiting, Injection site anaesthesia, Injection site paraesthesia, Erythema, Fatigue, Fibromyalgia, Feeling abnormal, Moaning, Fall, Emotional disorder, Amnesia, Somatisation disorder, Foaming at mouth, Tremor, Somnolence, Eye disorder, Abnormal dreams, Nervous system disorderHoursWorseDescription of pain fulfills criteria of CRPS(allodynia was reported, but pain was not confined to limb). Medical history includes abdominal pain with diagnosis of chronic appendicitis, and occasional abdominal pain after surgery Confirmed case of CRPSUK12 Contusion, Swelling, Skin lesion, Pain, Complex regional pain syndromeUnknownUnresolvedUnconfirmed case of CRPS due to insufficient evidence to meet diagnostic criteria of CRPS. Reported symptoms included contusion, swelling, skin lesion and pain located over the dorsum of the hands, feet, iliac crests or face Not confirmed as CRPSJapan14 Injected limb mobility decreased, Injection site pain, Oedema peripheral, Pallor, Grip strength decreased, Musculoskeletal pain, Asthenia, Syncope, Coordination abnormal, Dizziness, Photopsia, Malaise, Urticaria, Insomnia, Dyspnoea, Hypoaesthesia, Anxiety, Confusional state, Depressed mood, Dysgeusia, Decreased appetite, Complex regional pain syndrome, Hyperventilation, Chest pain, Peripheral coldness, Feeling cold, Abdominal pain, Headache, Nausea, Dysstasia, Pain, Muscular weakness, Chest discomfort, Sensory disturbance, Swelling, Loss of consciousness, Muscle atrophy, Neuralgia, Muscle spasms, Pain in extremity, Abasia, Middle insomnia, Nervous system disorder, Ill-defined disorder, Temperature intolerance13 MonthsUnknownUnconfirmed case of CRPS. Continuous sever pain was reported in vaccinated arm, along with swaying feeling, giddiness, flickering in the eyes, malaise, weakness, numbness, weakness, and coldness of upper and lower extremities, lower limb oedema, pain in the chest and leg, dyspnoea, hyperpnoea, slight fever, stomatitis, worsening of painful menses, and taste disturbance. Initially, no symptoms related to local presentation of CRPS were reportedConfirmed case of CRPSJapan24 Complex regional pain syndrome, Arthralgia, Arthropathy, Pain in extremity, Eczema2 YearsUnknownUnconfirmed case of CRPS due to insufficient evidence to meet diagnostic criteria of CRPS. Arthralgia was reported as leading symptom Not confirmed as CRPSJapan12 Joint swelling, Arthralgia, Pyrexia, Pain in extremity, Malaise, Abdominal pain, Lymphadenopathy, Lymph node pain, Orthostatic intolerance, Allodynia, Complex regional pain syndrome, Menstruation irregular, Headache, Somnolence, Hypotension1 YearsUnknownUnlikely case of CRPS. Localisation of pain and oedema were multiple, leading complains were related to swollen and painful joints. Systemic lupus erythematous was ruled out. Allodynia was reported to be observed at abdomen and entire thigh Not confirmed as CRPSJapan12 Complex regional pain syndrome, Nervous system disorder, Back pain, Muscular weakness, Asterixis, Gait disturbance, Hypoaesthesia, Sensory disturbance, Pain, Asthenia0 WeeksUnknownUnlikely case of CRPS. Reported events included generalised pain, walking difficulties, limb numbness and sensory aberrationsNot confirmed as CRPSUK12 Complex regional pain syndrome, Paraesthesia, Muscular weakness, Pain in extremity, Pallor, Skin discolouration, Body temperature decreased, Oedema, Injected limb mobility decreased1 HoursResolvedFulfils diagnostic criteria for CRPS with symptomsdisproportionate to inciting event (paraesthesiaprogressing to left arm weakness and pain, skindiscoloration, temperature changes, oedema and decreased limb mobility)Confirmed case of CRPSJapan12 Complex regional pain syndrome, Pain in extremity, Musculoskeletal stiffness1 DaysResolvedUnlikely case of CRPS. Reported symptoms included pain in the area between the left buttock and the femoral region which persisted for 2 weeks and then followed by stiffness of the left kneeNot confirmed as CRPSJapan12 Complex regional pain syndrome, Arthralgia, Dysstasia, Gait disturbance, Skin exfoliation, Bursitis, Pyrexia, Back pain, Psychosomatic disease12 MonthsUnknownUnlikely case of CRPS. Reported symptoms included severe right medial knee pain, difficulty in standing and walking and myalgiaNot confirmed as CRPSJapan13 Complex regional pain syndrome, Malaise, Pain, Swelling face, Facial pain, Tenderness, Asthenia, Abdominal tenderness, Migraine, Arthralgia, Headache, Urticaria, Nausea2 MonthsUnknownUnlikely case of CRPS. Reported symptoms included urticarial, migrated pain, migraine, swelling of face, physical deconditioning, lower abdominal tenderness, lower jaw tenderness, tenderness of arm, tender back and arthralgia Not confirmed as CRPS ................
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