Trial Outcomes & Findings for Validation of a Diagnostic Algorithm of Giant Cell Arteritis (NCT NCT02703922)

Last Updated: 2024-12-13

Results Overview

patients with an alternative diagnosis within 2 years of follow-up among patients considered with giant cell arteritis (GCA) on a clinico-biological suspicion + Doppler "positive."

Recruitment status

COMPLETED

Study phase

Target enrollment

165 participants

Primary outcome timeframe

after 2 years of follow-up

Results posted on

2024-12-13

Participant Flow

Recruitment period: from end of August 2016 to February 2020 Type of location: five public hospitals

Participant milestones

Participant milestones
Measure	CDU Positive A first screening is performed using color Doppler ultrasound (CDU). "CDU Positive" refers to patients with a bilateral clear halo sign (defined as homogenous, hypoechoic wall thickening, well-delineated toward the luminal side, visible both in longitudinal and transverse planes located on the superficial temporal arteries, trunk or branches) detected by color Doppler ultrasound	CDU Negative A first screening is performed using color Doppler ultrasound (CDU). "CDU negative" refers to patient with no sign or a unilateral halo sign on the temporal artery.
Overall Study STARTED	73	92
Overall Study COMPLETED	58	74
Overall Study NOT COMPLETED	15	18

Reasons for withdrawal

Reasons for withdrawal
Measure	CDU Positive A first screening is performed using color Doppler ultrasound (CDU). "CDU Positive" refers to patients with a bilateral clear halo sign (defined as homogenous, hypoechoic wall thickening, well-delineated toward the luminal side, visible both in longitudinal and transverse planes located on the superficial temporal arteries, trunk or branches) detected by color Doppler ultrasound	CDU Negative A first screening is performed using color Doppler ultrasound (CDU). "CDU negative" refers to patient with no sign or a unilateral halo sign on the temporal artery.
Overall Study Death	5	8
Overall Study Lost to Follow-up	10	10

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CDU Positive n=73 Participants A first screening is performed using color Doppler ultrasound (CDU). "CDU Positive" refers to patients with a bilateral clear halo sign (defined as homogenous, hypoechoic wall thickening, well-delineated toward the luminal side, visible both in longitudinal and transverse planes located on the superficial temporal arteries, trunk or branches) detected by color Doppler ultrasound	CDU Negative n=92 Participants A first screening is performed using color Doppler ultrasound (CDU). "CDU negative" refers to patient with no sign or a unilateral halo sign on the temporal artery.	Total n=165 Participants Total of all reporting groups
Age, Continuous	79.6 years STANDARD_DEVIATION 7.8 • n=73 Participants	78 years STANDARD_DEVIATION 9.6 • n=92 Participants	78.7 years STANDARD_DEVIATION 8.8 • n=165 Participants
Sex: Female, Male Female	42 Participants n=73 Participants	60 Participants n=92 Participants	102 Participants n=165 Participants
Sex: Female, Male Male	31 Participants n=73 Participants	32 Participants n=92 Participants	63 Participants n=165 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	73 participants n=73 Participants	92 participants n=92 Participants	165 participants n=165 Participants

PRIMARY outcome

Timeframe: after 2 years of follow-up

Population: Patients followed up at two years

patients with an alternative diagnosis within 2 years of follow-up among patients considered with giant cell arteritis (GCA) on a clinico-biological suspicion + Doppler "positive."

Outcome measures

Outcome measures
Measure	CDU Positive n=73 Participants A first screening is performed using color Doppler ultrasound (CDU). "CDU Positive" refers to patients with a bilateral clear halo sign (defined as homogenous, hypoechoic wall thickening, well-delineated toward the luminal side, visible both in longitudinal and transverse planes located on the superficial temporal arteries, trunk or branches) detected by color Doppler ultrasound	CDU Negative n=92 Participants A first screening is performed using color Doppler ultrasound (CDU). "CDU negative" refers to patient with no sign or a unilateral halo sign on the temporal artery.
Number of CDU False-positive Patients Patients diagnosed with giant cell arteritis	73 Participants	63 Participants
Number of CDU False-positive Patients Alternative diagnosis	0 Participants	29 Participants

SECONDARY outcome

Timeframe: within 1 month (during diagnostic algorithm)

Number of temporal artery biopsy (TAB) positive patients among patients with negative or doubtful CDU

Outcome measures

Outcome measures
Measure	CDU Positive n=92 Participants A first screening is performed using color Doppler ultrasound (CDU). "CDU Positive" refers to patients with a bilateral clear halo sign (defined as homogenous, hypoechoic wall thickening, well-delineated toward the luminal side, visible both in longitudinal and transverse planes located on the superficial temporal arteries, trunk or branches) detected by color Doppler ultrasound	CDU Negative A first screening is performed using color Doppler ultrasound (CDU). "CDU negative" refers to patient with no sign or a unilateral halo sign on the temporal artery.
Rate of "Temporal Artery Biopsy Positive" Among "Negative or Doubtful CDU " TAB negative	28 Participants	—
Rate of "Temporal Artery Biopsy Positive" Among "Negative or Doubtful CDU " TAB positive	57 Participants	—
Rate of "Temporal Artery Biopsy Positive" Among "Negative or Doubtful CDU " Uninterpretable	7 Participants	—

SECONDARY outcome

Timeframe: after 2 years of follow-up

Describe S3/S4 Halo changes, and study correlation between persistence and poorer clinical response

Outcome measures

Outcome measures
Measure	CDU Positive n=73 Participants A first screening is performed using color Doppler ultrasound (CDU). "CDU Positive" refers to patients with a bilateral clear halo sign (defined as homogenous, hypoechoic wall thickening, well-delineated toward the luminal side, visible both in longitudinal and transverse planes located on the superficial temporal arteries, trunk or branches) detected by color Doppler ultrasound	CDU Negative A first screening is performed using color Doppler ultrasound (CDU). "CDU negative" refers to patient with no sign or a unilateral halo sign on the temporal artery.
Number of Patients With a Persistent Halo at Second CDU Examination Stable	9 Participants	—
Number of Patients With a Persistent Halo at Second CDU Examination Improvement	30 Participants	—
Number of Patients With a Persistent Halo at Second CDU Examination No more Halo	25 Participants	—
Number of Patients With a Persistent Halo at Second CDU Examination Not done	9 Participants	—

SECONDARY outcome

Timeframe: 1 month (after second blind reading of histological specimen and doppler imaging)

Population: According to the diagnostic algorithm, only ultrasound-negative patients underwent temporal artery biopsy within 7 days after the ultrasound

Reproducibility of TAB interpretation

Outcome measures

Outcome measures
Measure	CDU Positive n=92 Participants A first screening is performed using color Doppler ultrasound (CDU). "CDU Positive" refers to patients with a bilateral clear halo sign (defined as homogenous, hypoechoic wall thickening, well-delineated toward the luminal side, visible both in longitudinal and transverse planes located on the superficial temporal arteries, trunk or branches) detected by color Doppler ultrasound	CDU Negative A first screening is performed using color Doppler ultrasound (CDU). "CDU negative" refers to patient with no sign or a unilateral halo sign on the temporal artery.
Number of Correctly Interpreted TAB First analysis · Negative	58 Participants	—
Number of Correctly Interpreted TAB First analysis · Positive	28 Participants	—
Number of Correctly Interpreted TAB First analysis · inconclusive	6 Participants	—
Number of Correctly Interpreted TAB First analysis · Not available	0 Participants	—
Number of Correctly Interpreted TAB Blinded expert analysis · Negative	55 Participants	—
Number of Correctly Interpreted TAB Blinded expert analysis · Positive	18 Participants	—
Number of Correctly Interpreted TAB Blinded expert analysis · inconclusive	4 Participants	—
Number of Correctly Interpreted TAB Blinded expert analysis · Not available	15 Participants	—

SECONDARY outcome

Timeframe: 1 month (after second blind reading of histological specimen and doppler imaging)

Reproducibility of CDU interpretation

Outcome measures

Outcome measures
Measure	CDU Positive n=73 Participants A first screening is performed using color Doppler ultrasound (CDU). "CDU Positive" refers to patients with a bilateral clear halo sign (defined as homogenous, hypoechoic wall thickening, well-delineated toward the luminal side, visible both in longitudinal and transverse planes located on the superficial temporal arteries, trunk or branches) detected by color Doppler ultrasound	CDU Negative n=92 Participants A first screening is performed using color Doppler ultrasound (CDU). "CDU negative" refers to patient with no sign or a unilateral halo sign on the temporal artery.
Number of Correctly Interpreted CDU First analysis · Positive	73 Participants	0 Participants
Number of Correctly Interpreted CDU First analysis · negative	0 Participants	92 Participants
Number of Correctly Interpreted CDU First analysis · Not available	0 Participants	0 Participants
Number of Correctly Interpreted CDU Blinded expert analysis · Positive	42 Participants	3 Participants
Number of Correctly Interpreted CDU Blinded expert analysis · negative	16 Participants	75 Participants
Number of Correctly Interpreted CDU Blinded expert analysis · Not available	15 Participants	14 Participants

Adverse Events

CDU Positive

Serious events: 12 serious events

Other events: 51 other events

Deaths: 5 deaths

CDU Negative

Serious events: 18 serious events

Other events: 50 other events

Deaths: 8 deaths

Serious adverse events

Other adverse events

Additional Information

Caroline Allix-Béguec, clinical research manager

Groupe Hospitalier de la Rochelle Ré Aunis

Phone: +33516494246

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	CDU Positive n=73 participants at risk A first screening is performed using color Doppler ultrasound (CDU). "CDU Positive" refers to patients with a bilateral clear halo sign (defined as homogenous, hypoechoic wall thickening, well-delineated toward the luminal side, visible both in longitudinal and transverse planes located on the superficial temporal arteries, trunk or branches) detected by color Doppler ultrasound resonance angiography and/or positron emission tomography and absence of obvious differential diagnosis.	CDU Negative n=92 participants at risk A first screening is performed using color Doppler ultrasound (CDU). "CDU negative" refers to patient with no sign or a unilateral halo sign on the temporal artery.
Renal and urinary disorders Acute prostatitis	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Blood and lymphatic system disorders Aneamia	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Cardiac disorders Aneurysm of abdominal aorta	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Cardiac disorders Aortic dissection rupture	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Cardiac disorders Arrhythmia	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
General disorders Asthenia	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Infections and infestations Bacteraemia	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Cardiac disorders Carotid artery stenosis	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Nervous system disorders Carpal tunnel syndrome	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Vascular disorders Cerebral vasculitis	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Nervous system disorders Cognitive disorders	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Infections and infestations Covid-19 respiratory infection	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Infections and infestations Dental abscess	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Renal and urinary disorders Dysfunction kidney	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Respiratory, thoracic and mediastinal disorders Emphysema	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Nervous system disorders Faint	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Musculoskeletal and connective tissue disorders Femoral neck fracture	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Musculoskeletal and connective tissue disorders Fracture due to osteoporosis	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Musculoskeletal and connective tissue disorders Fracture of vertebral column without mention of spinal cord injury	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
General disorders Generalised chest pains	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Endocrine disorders Hemithyroidectomy	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Cardiac disorders High grade atrioventricular block	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Blood and lymphatic system disorders Hyponatraemia	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Hepatobiliary disorders Ischemic colitis	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Surgical and medical procedures Joint arthroplasty	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Renal and urinary disorders Kidney failure	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Blood and lymphatic system disorders Leukemia	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Musculoskeletal and connective tissue disorders Lumbar vertebral fracture L1	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Blood and lymphatic system disorders Myelodysplasia	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Product Issues Osteoporosis steroid-induced	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	2.2% 2/92 • Number of events 2 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Nervous system disorders Pachymeningitis	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Musculoskeletal and connective tissue disorders Palsy	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Respiratory, thoracic and mediastinal disorders Pneumopathy	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Infections and infestations Sepsis	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Infections and infestations Spondylodiscitis	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Nervous system disorders Stroke	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Skin and subcutaneous tissue disorders Tongue necrosis	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Skin and subcutaneous tissue disorders Urticaria recurrent	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.

Other adverse events
Measure	CDU Positive n=73 participants at risk A first screening is performed using color Doppler ultrasound (CDU). "CDU Positive" refers to patients with a bilateral clear halo sign (defined as homogenous, hypoechoic wall thickening, well-delineated toward the luminal side, visible both in longitudinal and transverse planes located on the superficial temporal arteries, trunk or branches) detected by color Doppler ultrasound resonance angiography and/or positron emission tomography and absence of obvious differential diagnosis.	CDU Negative n=92 participants at risk A first screening is performed using color Doppler ultrasound (CDU). "CDU negative" refers to patient with no sign or a unilateral halo sign on the temporal artery.
General disorders Abnormal weight gain	2.7% 2/73 • Number of events 2 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	5.4% 5/92 • Number of events 5 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Skin and subcutaneous tissue disorders Abscesses of skin	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Cardiac disorders Acute coronary syndrome	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Renal and urinary disorders Acute kidney failure	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Skin and subcutaneous tissue disorders Adenoma	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Eye disorders Amaurosis	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Musculoskeletal and connective tissue disorders Amyotrophy	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Blood and lymphatic system disorders Aneamia	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
General disorders Anorexia	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Gastrointestinal disorders Antral gastritis	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Psychiatric disorders Anxiety	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Psychiatric disorders Anxiodepressive syndrome	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Cardiac disorders Aortitis	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Nervous system disorders Arnold neuralgia	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Eye disorders Arteritic anterior ischaemic optic neuropathy	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
General disorders Asthenia	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	3.3% 3/92 • Number of events 3 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Cardiac disorders Atrial fibrillation	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Musculoskeletal and connective tissue disorders Back ache	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Blood and lymphatic system disorders Bateman's purpura senilis	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	2.2% 2/92 • Number of events 2 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
General disorders Belly ache	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Vascular disorders Bleeding piles	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Eye disorders Blepharitis unspecified	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	2.2% 2/92 • Number of events 2 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Musculoskeletal and connective tissue disorders Bursitis	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Musculoskeletal and connective tissue disorders Calf swelling	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Immune system disorders Carcinoma	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Eye disorders Cataract	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
General disorders Cervical pain	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Respiratory, thoracic and mediastinal disorders Chest pain	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Blood and lymphatic system disorders Chronic myelomonocytic leukemia	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Musculoskeletal and connective tissue disorders Claudication of jaw muscles	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Nervous system disorders Cognitive disorders	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Musculoskeletal and connective tissue disorders Coxarthrosis	0.00% 0/73 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	1.1% 1/92 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Musculoskeletal and connective tissue disorders Cramps	5.5% 4/73 • Number of events 4 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
General disorders C-reactive protein increased	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	3.3% 3/92 • Number of events 3 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Endocrine disorders Cushingoid facies	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Vascular disorders Deep vein thrombosis	1.4% 1/73 • Number of events 1 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	0.00% 0/92 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
Endocrine disorders Diabetes mellitus	4.1% 3/73 • Number of events 3 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.	5.4% 5/92 • Number of events 5 • Two years after inclusion This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age \>50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.