Baricitinib
Label Information Related to Hypersensitivity
Contraindications,
Warnings and Precautions
Baricitinib
is contraindicated in case of hypersensitivity to the active
substance or to any of the excipients.1
In
post-marketing experience, cases of drug hypersensitivity associated
with baricitinib administration have been reported.1
If
any serious allergic or anaphylactic reaction occurs, baricitinib
should be discontinued immediately.1
Adverse
Drug Reactions: Rash, Urticaria, and Swelling of the Face
Rash
was a common adverse drug reaction (≥1/100 to <1/10) in
patients treated with BARI in clinical trials. Urticaria and swelling
of the face were uncommon adverse drug reactions (≥1/1,000
to <1/100) in patients treated with BARI in clinical
trials.1
Atopic
Dermatitis Clinical Development Program Exclusion Criteria
In
the BARI AD clinical trials, BARI was not to be used in patients with
hypersensitivity to the active substance or to any of its
excipients.2
Hypersensitivity
in the Baricitinib Atopic Dermatitis Development Program
Patients
with AD have an increased risk of general allergic reactions,
including food and airborne allergens.
The
risk of developing allergies is related to the epidermal permeability
barrier defect and a genetic predisposition in patients with elevated
serum Ig E and allergen-specific Ig E, facilitating allergen
sensitization.3
Therefore,
an assessment of allergic and hypersensitivity reactions was
incorporated into the baricitinib development program.
Hypersensitivity
- Definition of Terms
Data
for hypersensitivity were searched based on the Hypersensitivity
Standardized Medical Dictionary for Regulatory Authorities Queries
(SMQ), which included the following MedDRA queries
hypersensitivity
SMQ (broad, narrow and [narrow] AD; see Table
3)
angioedema
SMQ (broad and narrow; see Table 4)
anaphylactic
reaction SMQ (broad, narrow, and algorithm; see Table
4).2
Dataset
Description
The
integrated datasets used to evaluate hypersensitivity reactions are
described in Table 2.
Treatment-Emergent
Adverse Events Including Hypersensitivity, Angioedema, and
Anaphylaxis
In
the 16-week placebo-controlled period, there was no statistical
difference p>.05) in hypersensitivity, angioedema, and
anaphylactic events between the BARI 4 mg or BARI 2 mg compared to
placebo. Additionally in the 16-week placebo-controlled period,
no TEAEs of anaphylaxis were identified by the anaphylactic reaction
SMQ (narrow search and algorithm; see Table
1).2
In
the extended period across all 3 SMQs, the majority of the adjusted
IRs for hypersensitivity, angioedema, and anaphylactic events
following narrow and broad search approaches were not statistically
different (p>.05) between the BARI 4 mg and BARI 2 mg groups. The
angioedema broad search term was significantly higher (p<.05) in
the BARI 4 mg group compared to BARI 2 mg in the extended period (see
Table 1).2
Table
1. Treatment-Emergent Adverse Events Including Anaphylactic,
Angioedema, and Hypersensitivity in Atopic Dermatitis Trials2
|
|
Hyper-sensitivity
Broad
|
Hyper-sensitivity
Narrow
|
Hyper-sensitivity
(Narrow) AD
|
Angioedema
Broad
|
Angioedema
Narrow
|
Anaphylactic
Reaction Broad
|
Anaphylactic
Reaction Narrow
|
Anaphylactic
Reaction Algorithm
|
|
BARI
2 mg Placebo-Controlleda,
n (adj %)b
|
|
Placebo,
n=889
|
73
(8.2)
|
51
(5.7)
|
19
(2.0)
|
19
(2.1)
|
10
(1.1)
|
46
(5.0)
|
0
|
0
|
|
BARI
2 mg, n=721
|
63
(8.6)
|
42
(5.9)
|
19
(2.4)
|
14
(1.7)
|
7
(0.9)
|
38
(4.9)
|
0
|
0
|
|
BARI
4 mg Placebo-Controlleda,
n (adj %)b
|
|
Placebo,
n=743
|
62
(6.9)
|
46
(5.1)
|
16
(1.7)
|
16
(1.7)
|
8
(0.9)
|
37
(4.0)
|
0
|
0
|
|
BARI
4 mg, n=489
|
44
(7.6)
|
30
(5.0)
|
14
(2.2)
|
12
(2.3)
|
5
(1.0)
|
24
(4.4)
|
0
|
0
|
|
BARI
2 vs 4 mga,
n (adj %)b
|
|
BARI
2 mg, n=576
|
53
(7.4)
|
38
(5.5)
|
17
(2.1)
|
12
(1.5)
|
7
(0.9)
|
33
(4.4)
|
0
|
0
|
|
BARI
4 mg, n=489
|
44
(7.6)
|
30
(5.0)
|
14
(2.2)
|
12
(2.3)
|
5
(1.0)
|
24
(4.4)
|
0
|
0
|
|
BARI
2 mg vs 4 mg extended, n (adj %)b
[adj IR]
|
|
BARI
2 mg, n=576
|
78
(11.5) [19.5]
|
54
(8.0) [13.1]
|
25
(3.4) [5.6]
|
18
(2.4) [3.9]
|
12
(1.7) [2.6]
|
47
(6.4) [10.6]
|
0
|
0
|
|
BARI
4 mg, n=489
|
81
(14.3) [20.5]
|
59
(10.2) [13.3]
|
29
(4.9) [6.4]
|
25
(4.5) [6.1]c
|
16
(2.8) [3.5]
|
46
(8.3) [11.6]
|
0
|
1
(0.2) [0.2]
|
|
All
BARI AD, n (%), [IR]
|
|
All
doses, N=2531
|
356
(14.1) [17.0]
|
234
(9.2) [10.7]
|
114
(4.5) [5.1]
|
89
(3.5) [3.9]
|
58
(2.3) [2.5]
|
207
(8.2) [9.5]
|
1
(0) [0]
|
3
(0.1) [0.1]
|
Abbreviations:
AD = atopic dermatitis; adj = adjusted; BARI = baricitinib; IR =
incidence rate.
a
Data through 16-week placebo-controlled period.
b
For the integrated controlled analysis sets where the
randomized ratio of patients receiving BARI to placebo or BARI to
active control is not the same across all the integrated studies
(example 2:1:1:1 vs 1:1:1:1), the study-size adjusted percentages
were calculated for the adverse events to provide appropriate direct
comparisons between treatment groups.
c
p<.05.
In
the All BARI AD dataset, the hypersensitivity TEAEs using broad
search terms led to
a
serious event in 42 (1.7%) patients
interruption
of treatment in 22 (0.9%) patients, and
discontinuation
of treatment in 28 (1.1%) patients.2
In
the All BARI AD dataset, the angioedema TEAEs using broad search
terms led to
a
serious event in 2 (0.1%) patients
interruption
of treatment in 1 (0%) patients, and
discontinuation
of treatment in 2 (0.1%) patients.2
In
the All BARI AD dataset, the anaphylactic TEAEs using broad search
terms led to
a
serious event in 9 (0.4%) patients
interruption
of treatment in 10 (0.4%) patients, and
discontinuation
of treatment in 7 (0.3%) patients.2
Integrated
Safety Datasets Table
Table
2. Integrated Analysis Datasets Used to Evaluate Safety in Atopic
Dermatitis Clinical Trials2
|
Analysis
Set
|
Description
|
|
BARI
2 mg Placebo-Controlled
Studies:
JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE- AD4, BREEZE- AD5, and
BREEZE-AD7
|
Compares
BARI 2 mg vs placebo
Includes
patients with AD from 1 phase 2 and 5 phase 3 studies who were
randomized to
BARI
2 mg (n=721, PYE =210.6), or
placebo
(n=889, PYE=252.7).
Treatment
period is 0 to 16 weeks.
|
|
BARI
4 mg Placebo-Controlled
Studies:
JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE- AD4, and BREEZE-AD7
|
Compares
BARI 4 mg vs placebo
Includes
patients with AD from 1 phase 2 and 4 phase 3 studies who were
randomized to
BARI
4 mg (n=489, PYE=147.1), or
placebo
(n=743, PYE=211.8).
Treatment
period is 0 to 16 weeks.
|
|
BARI
2 mg vs 4 mg
Studies:
JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE-AD4, and BREEZE-AD7
|
Compares
BARI 2 mg vs BARI 4 mg through 16 weeks
Includes
patients with AD from 1 phase 2 and 4 phase 3 studies who were
randomized to
BARI
2 mg (n=576, PYE=169.1), or
BARI
4 mg (n=489, PYE=147.1).
Treatment
is 0 to 16 weeks during the placebo-controlled period.
|
|
BARI
2 mg vs 4 mg Extended
Studies:
JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE-AD4, BREEZE-AD7, and
extension study BREEZE-AD3
|
Compares
BARI 2 mg vs BARI 4 mg including extended evaluations
Includes
patients with AD from 1 phase 2 and 4 phase 3 studies and any
further exposure for those patients in the phase 3 extension
study, BREEZE-AD3, who were randomized to
BARI
2 mg (n=576, PYE=425.5), or
BARI
4 mg (n=489, PYE=459.3).
Treatment
period is 0 to 16 weeks.
Data
censored at dose or treatment change (rescue, dose switch, or
re-randomization to a different BARI dose or placebo) for
BREEZE-AD4 and BREEZE-AD3.
|
|
All
BARI AD
Studies:
JAHG, BREEZE-AD1, BREEZE-AD2, BREEZE-AD4, BREEZE-AD5, BREEZE-AD7,
and extension studies BREEZE-AD3, BREEZE-AD6
|
No
between-group comparisons
Includes
2531 (total PYE=2247.4) patients with AD from 1 phase 2, 5 phase
3, and 2 phase 3 extension studies who received BARI at a variety
of doses, including
BARI
1 mg (n=538, PYE=245.9)
BARI
2 mg (n=1580, PYE=1129.5), and
BARI
4 mg (n=914, PYE=872.8).
Includes
all patients who were exposed to any BARI dose at any time during
the studies, either from randomization or from switch or rescue
from placebo.
No
censoring of data at dose change.
|
Abbreviations:
AD = atopic dermatitis; BARI = baricitinib; PYE = patient years of
exposure.
Note:
BARI 1 mg was studied in pivotal trials, however it is not approved.
Please refer to section 4.2 of the Olumiant Summary of Product
Characteristics for approved dosage.
Hypersensitivity
Standardized Medical Dictionary for Regulatory Authorities Queries
Table
3. Standardized MedDRA Hypersensitivity Query (SMQ) Preferred Terms2
|
|
Hypersensitivity
SMQ (20000214) a
|
|
|
Search
Type
|
Category
|
Preferred
Term
|
|
Narrow
|
A
|
Acquired
C1 inhibitor deficiency
|
|
Narrow
|
A
|
Acute
generalised exanthematous pustulosis
|
|
Narrow
|
A
|
Administration
related reaction
|
|
Narrow
|
A
|
Administration
site dermatitis
|
|
Narrow
|
A
|
Administration
site eczema
|
|
Narrow
|
A
|
Administration
site hypersensitivity
|
|
Narrow
|
A
|
Administration
site rash
|
|
Narrow
|
A
|
Administration
site recall reaction
|
|
Narrow
|
A
|
Administration
site urticaria
|
|
Narrow
|
A
|
Administration
site vasculitis
|
|
Narrow
|
A
|
Allergic
bronchitis
|
|
Narrow
|
A
|
Allergic
colitis
|
|
Narrow
|
A
|
Allergic
cough
|
|
Narrow
|
A
|
Allergic
cystitis
|
|
Narrow
|
A
|
Allergic
eosinophilia
|
|
Narrow
|
A
|
Allergic
gastroenteritis
|
|
Narrow
|
A
|
Allergic
hepatitis
|
|
Narrow
|
A
|
Allergic
keratitis
|
|
Narrow
|
A
|
Allergic
oedema
|
|
Narrow
|
A
|
Allergic
otitis externa
|
|
Narrow
|
A
|
Allergic
otitis media
|
|
Narrow
|
A
|
Allergic
pharyngitis
|
|
Narrow
|
A
|
Allergic
reaction to excipient
|
|
Narrow
|
A
|
Allergic
respiratory disease
|
|
Narrow
|
A
|
Allergic
respiratory symptom
|
|
Narrow
|
A
|
Allergic
sinusitis
|
|
Narrow
|
A
|
Allergic
stomatitis
|
|
Narrow
|
A
|
Allergic
transfusion reaction
|
|
Narrow
|
A
|
Allergy
alert test positive
|
|
Narrow
|
A
|
Allergy
test positive
|
|
Narrow
|
A
|
Allergy
to immunoglobulin therapy
|
|
Narrow
|
A
|
Allergy
to surgical sutures
|
|
Narrow
|
A
|
Allergy
to vaccine
|
|
Narrow
|
A
|
Anal
eczema
|
|
Narrow
|
A
|
Anaphylactic
reaction
|
|
Narrow
|
A
|
Anaphylactic
shock
|
|
Narrow
|
A
|
Anaphylactic
transfusion reaction
|
|
Narrow
|
A
|
Anaphylactoid
reaction
|
|
Narrow
|
A
|
Anaphylactoid
shock
|
|
Narrow
|
A
|
Anaphylaxis
treatment
|
|
Narrow
|
A
|
Angioedema
|
|
Narrow
|
A
|
Antiallergic
therapy
|
|
Narrow
|
A
|
Antiendomysial
antibody positive
|
|
Narrow
|
A
|
Anti-neutrophil
cytoplasmic antibody positive vasculitis
|
|
Narrow
|
A
|
Application
site dermatitis
|
|
Narrow
|
A
|
Application
site eczema
|
|
Narrow
|
A
|
Application
site hypersensitivity
|
|
Narrow
|
A
|
Application
site rash
|
|
Narrow
|
A
|
Application
site recall reaction
|
|
Narrow
|
A
|
Application
site urticaria
|
|
Narrow
|
A
|
Application
site vasculitis
|
|
Narrow
|
A
|
Arthritis
allergic
|
|
Narrow
|
A
|
Aspirin-exacerbated
respiratory disease
|
|
Narrow
|
A
|
Atopic
cough
|
|
Narrow
|
A
|
Atopy
|
|
Narrow
|
A
|
Blepharitis
allergic
|
|
Narrow
|
A
|
Blood
immunoglobulin E abnormal
|
|
Narrow
|
A
|
Blood
immunoglobulin E increased
|
|
Narrow
|
A
|
Bromoderma
|
|
Narrow
|
A
|
Bronchospasm
|
|
Narrow
|
A
|
Bullous
haemorrhagic dermatosis
|
|
Narrow
|
A
|
Catheter
site dermatitis
|
|
Narrow
|
A
|
Catheter
site eczema
|
|
Narrow
|
A
|
Catheter
site hypersensitivity
|
|
Narrow
|
A
|
Catheter
site rash
|
|
Narrow
|
A
|
Catheter
site urticaria
|
|
Narrow
|
A
|
Catheter
site vasculitis
|
|
Narrow
|
A
|
Chronic
eosinophilic rhinosinusitis
|
|
Narrow
|
A
|
Chronic
hyperplastic eosinophilic sinusitis
|
|
Narrow
|
A
|
Circulatory
collapse
|
|
Narrow
|
A
|
Circumoral
oedema
|
|
Narrow
|
A
|
Circumoral
swelling
|
|
Narrow
|
A
|
Conjunctival
oedema
|
|
Narrow
|
A
|
Conjunctivitis
allergic
|
|
Narrow
|
A
|
Contact
stomatitis
|
|
Narrow
|
A
|
Contrast
media allergy
|
|
Narrow
|
A
|
Contrast
media reaction
|
|
Narrow
|
A
|
Corneal
oedema
|
|
Narrow
|
A
|
Cutaneous
vasculitis
|
|
Narrow
|
A
|
Dennie-Morgan
fold
|
|
Narrow
|
A
|
Dermatitis
|
|
Narrow
|
A
|
Dermatitis
acneiform
|
|
Narrow
|
A
|
Dermatitis
allergic
|
|
Narrow
|
A
|
Dermatitis
atopic
|
|
Narrow
|
A
|
Dermatitis
bullous
|
|
Narrow
|
A
|
Dermatitis
contact
|
|
Narrow
|
A
|
Dermatitis
exfoliative
|
|
Narrow
|
A
|
Dermatitis
exfoliative generalised
|
|
Narrow
|
A
|
Dermatitis
herpetiformis
|
|
Narrow
|
A
|
Dermatitis
infected
|
|
Narrow
|
A
|
Dermatitis
psoriasiform
|
|
Narrow
|
A
|
Device
allergy
|
|
Narrow
|
A
|
Dialysis
membrane reaction
|
|
Narrow
|
A
|
Distributive
shock
|
|
Narrow
|
A
|
Documented
hypersensitivity to administered product
|
|
Narrow
|
A
|
Drug
eruption
|
|
Narrow
|
A
|
Drug
hypersensitivity
|
|
Narrow
|
A
|
Drug
provocation test
|
|
Narrow
|
A
|
Drug
reaction with eosinophilia and systemic symptoms
|
|
Narrow
|
A
|
Eczema
|
|
Narrow
|
A
|
Eczema
infantile
|
|
Narrow
|
A
|
Eczema
nummular
|
|
Narrow
|
A
|
Eczema
vaccinatum
|
|
Narrow
|
A
|
Eczema
vesicular
|
|
Narrow
|
A
|
Eczema
weeping
|
|
Narrow
|
A
|
Encephalitis
allergic
|
|
Narrow
|
A
|
Encephalopathy
allergic
|
|
Narrow
|
A
|
Eosinophilic
granulomatosis with polyangiitis
|
|
Narrow
|
A
|
Epidermal
necrosis
|
|
Narrow
|
A
|
Epidermolysis
|
|
Narrow
|
A
|
Epidermolysis
bullosa
|
|
Narrow
|
A
|
Epiglottic
oedema
|
|
Narrow
|
A
|
Erythema
multiforme
|
|
Narrow
|
A
|
Erythema
nodosum
|
|
Narrow
|
A
|
Exfoliative
rash
|
|
Narrow
|
A
|
Eye
allergy
|
|
Narrow
|
A
|
Eye
oedema
|
|
Narrow
|
A
|
Eye
swelling
|
|
Narrow
|
A
|
Eyelid
oedema
|
|
Narrow
|
A
|
Face
oedema
|
|
Narrow
|
A
|
Fixed
eruption
|
|
Narrow
|
A
|
Giant
papillary conjunctivitis
|
|
Narrow
|
A
|
Gingival
oedema
|
|
Narrow
|
A
|
Gingival
swelling
|
|
Narrow
|
A
|
Gleich's
syndrome
|
|
Narrow
|
A
|
Haemorrhagic
urticaria
|
|
Narrow
|
A
|
Hand
dermatitis
|
|
Narrow
|
A
|
Henoch-Schonlein
purpura
|
|
Narrow
|
A
|
Henoch-Schonlein
purpura nephritis
|
|
Narrow
|
A
|
Heparin-induced
thrombocytopenia
|
|
Narrow
|
A
|
Hereditary
angioedema
|
|
Narrow
|
A
|
Hereditary
angioedema with C1 esterase inhibitor deficiency
|
|
Narrow
|
A
|
Hypersensitivity
|
|
Narrow
|
A
|
Hypersensitivity
myocarditis
|
|
Narrow
|
A
|
Hypersensitivity
pneumonitis
|
|
Narrow
|
A
|
Hypersensitivity
vasculitis
|
|
Narrow
|
A
|
Idiopathic
urticaria
|
|
Narrow
|
A
|
Immediate
post-injection reaction
|
|
Narrow
|
A
|
Immune
thrombocytopenia
|
|
Narrow
|
A
|
Immune
tolerance induction
|
|
Narrow
|
A
|
Implant
site dermatitis
|
|
Narrow
|
A
|
Implant
site hypersensitivity
|
|
Narrow
|
A
|
Implant
site rash
|
|
Narrow
|
A
|
Implant
site urticaria
|
|
Narrow
|
A
|
Incision
site dermatitis
|
|
Narrow
|
A
|
Incision
site rash
|
|
Narrow
|
A
|
Infusion
related hypersensitivity reaction
|
|
Narrow
|
A
|
Infusion
related reaction
|
|
Narrow
|
A
|
Infusion
site dermatitis
|
|
Narrow
|
A
|
Infusion
site eczema
|
|
Narrow
|
A
|
Infusion
site hypersensitivity
|
|
Narrow
|
A
|
Infusion
site rash
|
|
Narrow
|
A
|
Infusion
site recall reaction
|
|
Narrow
|
A
|
Infusion
site urticaria
|
|
Narrow
|
A
|
Infusion
site vasculitis
|
|
Narrow
|
A
|
Injection
related reaction
|
|
Narrow
|
A
|
Injection
site dermatitis
|
|
Narrow
|
A
|
Injection
site eczema
|
|
Narrow
|
A
|
Injection
site hypersensitivity
|
|
Narrow
|
A
|
Injection
site rash
|
|
Narrow
|
A
|
Injection
site recall reaction
|
|
Narrow
|
A
|
Injection
site urticaria
|
|
Narrow
|
A
|
Injection
site vasculitis
|
|
Narrow
|
A
|
Instillation
site hypersensitivity
|
|
Narrow
|
A
|
Instillation
site rash
|
|
Narrow
|
A
|
Instillation
site urticaria
|
|
Narrow
|
A
|
Interstitial
granulomatous dermatitis
|
|
Narrow
|
A
|
Intestinal
angioedema
|
|
Narrow
|
A
|
Iodine
allergy
|
|
Narrow
|
A
|
Kaposi's
varicelliform eruption
|
|
Narrow
|
A
|
Kounis
syndrome
|
|
Narrow
|
A
|
Laryngeal
oedema
|
|
Narrow
|
A
|
Laryngitis
allergic
|
|
Narrow
|
A
|
Laryngospasm
|
|
Narrow
|
A
|
Laryngotracheal
oedema
|
|
Narrow
|
A
|
Limbal
swelling
|
|
Narrow
|
A
|
Lip
oedema
|
|
Narrow
|
A
|
Lip
swelling
|
|
Narrow
|
A
|
Mast
cell degranulation present
|
|
Narrow
|
A
|
Medical
device site dermatitis
|
|
Narrow
|
A
|
Medical
device site eczema
|
|
Narrow
|
A
|
Medical
device site hypersensitivity
|
|
Narrow
|
A
|
Medical
device site rash
|
|
Narrow
|
A
|
Medical
device site recall reaction
|
|
Narrow
|
A
|
Medical
device site urticaria
|
|
Narrow
|
A
|
Mouth
swelling
|
|
Narrow
|
A
|
Mucocutaneous
rash
|
|
Narrow
|
A
|
Multiple
allergies
|
|
Narrow
|
A
|
Nephritis
allergic
|
|
Narrow
|
A
|
Nikolsky's
sign
|
|
Narrow
|
A
|
Nodular
rash
|
|
Narrow
|
A
|
Nutritional
supplement allergy
|
|
Narrow
|
A
|
Oculomucocutaneous
syndrome
|
|
Narrow
|
A
|
Oculorespiratory
syndrome
|
|
Narrow
|
A
|
Oedema
mouth
|
|
Narrow
|
A
|
Oral
allergy syndrome
|
|
Narrow
|
A
|
Oropharyngeal
blistering
|
|
Narrow
|
A
|
Oropharyngeal
oedema
|
|
Narrow
|
A
|
Oropharyngeal
spasm
|
|
Narrow
|
A
|
Oropharyngeal
swelling
|
|
Narrow
|
A
|
Palatal
oedema
|
|
Narrow
|
A
|
Palatal
swelling
|
|
Narrow
|
A
|
Palisaded
neutrophilic granulomatous dermatitis
|
|
Narrow
|
A
|
Palpable
purpura
|
|
Narrow
|
A
|
Pathergy
reaction
|
|
Narrow
|
A
|
Perioral
dermatitis
|
|
Narrow
|
A
|
Periorbital
oedema
|
|
Narrow
|
A
|
Periorbital
swelling
|
|
Narrow
|
A
|
Pharyngeal
oedema
|
|
Narrow
|
A
|
Pharyngeal
swelling
|
|
Narrow
|
A
|
Procedural
shock
|
|
Narrow
|
A
|
Pruritus
allergic
|
|
Narrow
|
A
|
Radioallergosorbent
test positive
|
|
Narrow
|
A
|
Rash
|
|
Narrow
|
A
|
Rash
erythematous
|
|
Narrow
|
A
|
Rash
follicular
|
|
Narrow
|
A
|
Rash
macular
|
|
Narrow
|
A
|
Rash
maculo-papular
|
|
Narrow
|
A
|
Rash
maculovesicular
|
|
Narrow
|
A
|
Rash
morbilliform
|
|
Narrow
|
A
|
Rash
neonatal
|
|
Narrow
|
A
|
Rash
papulosquamous
|
|
Narrow
|
A
|
Rash
pruritic
|
|
Narrow
|
A
|
Rash
pustular
|
|
Narrow
|
A
|
Rash
rubelliform
|
|
Narrow
|
A
|
Rash
scarlatiniform
|
|
Narrow
|
A
|
Rash
vesicular
|
|
Narrow
|
A
|
Reaction
to azo-dyes
|
|
Narrow
|
A
|
Reaction
to colouring
|
|
Narrow
|
A
|
Reaction
to excipient
|
|
Narrow
|
A
|
Reaction
to food additive
|
|
Narrow
|
A
|
Reaction
to preservatives
|
|
Narrow
|
A
|
Red
man syndrome
|
|
Narrow
|
A
|
Rhinitis
allergic
|
|
Narrow
|
A
|
Scleral
oedema
|
|
Narrow
|
A
|
Scleritis
allergic
|
|
Narrow
|
A
|
Scrotal
dermatitis
|
|
Narrow
|
A
|
Scrotal
oedema
|
|
Narrow
|
A
|
Serum
sickness
|
|
Narrow
|
A
|
Serum
sickness-like reaction
|
|
Narrow
|
A
|
Shock
|
|
Narrow
|
A
|
Shock
symptom
|
|
Narrow
|
A
|
SJS-TEN
overlap
|
|
Narrow
|
A
|
Skin
necrosis
|
|
Narrow
|
A
|
Skin
reaction
|
|
Narrow
|
A
|
Skin
test positive
|
|
Narrow
|
A
|
Solar
urticaria
|
|
Narrow
|
A
|
Solvent
sensitivity
|
|
Narrow
|
A
|
Stevens-Johnson
syndrome
|
|
Narrow
|
A
|
Stoma
site hypersensitivity
|
|
Narrow
|
A
|
Stoma
site rash
|
|
Narrow
|
A
|
Swelling
face
|
|
Narrow
|
A
|
Swelling
of eyelid
|
|
Narrow
|
A
|
Swollen
tongue
|
|
Narrow
|
A
|
Symmetrical
drug-related intertriginous and flexural exanthema
|
|
Narrow
|
A
|
Therapeutic
product cross-reactivity
|
|
Narrow
|
A
|
Tongue
oedema
|
|
Narrow
|
A
|
Toxic
epidermal necrolysis
|
|
Narrow
|
A
|
Toxic
skin eruption
|
|
Narrow
|
A
|
Tracheal
oedema
|
|
Narrow
|
A
|
Type
I hypersensitivity
|
|
Narrow
|
A
|
Type
II hypersensitivity
|
|
Narrow
|
A
|
Type
III immune complex mediated reaction
|
|
Narrow
|
A
|
Type
IV hypersensitivity reaction
|
|
Narrow
|
A
|
Urticaria
|
|
Narrow
|
A
|
Urticaria
cholinergic
|
|
Narrow
|
A
|
Urticaria
chronic
|
|
Narrow
|
A
|
Urticaria
contact
|
|
Narrow
|
A
|
Urticaria
papular
|
|
Narrow
|
A
|
Urticaria
physical
|
|
Narrow
|
A
|
Urticaria
pigmentosa
|
|
Narrow
|
A
|
Urticaria
vesiculosa
|
|
Narrow
|
A
|
Urticarial
dermatitis
|
|
Narrow
|
A
|
Urticarial
vasculitis
|
|
Narrow
|
A
|
Vaccination
site dermatitis
|
|
Narrow
|
A
|
Vaccination
site eczema
|
|
Narrow
|
A
|
Vaccination
site exfoliation
|
|
Narrow
|
A
|
Vaccination
site hypersensitivity
|
|
Narrow
|
A
|
Vaccination
site rash
|
|
Narrow
|
A
|
Vaccination
site recall reaction
|
|
Narrow
|
A
|
Vaccination
site urticaria
|
|
Narrow
|
A
|
Vaccination
site vasculitis
|
|
Narrow
|
A
|
Vaccination
site vesicles
|
|
Narrow
|
A
|
Vaginal
ulceration
|
|
Narrow
|
A
|
Vasculitic
rash
|
|
Narrow
|
A
|
Vernal
keratoconjunctivitis
|
|
Narrow
|
A
|
Vessel
puncture site rash
|
|
Narrow
|
A
|
Vessel
puncture site vesicles
|
|
Narrow
|
A
|
Vulval
eczema
|
|
Narrow
|
A
|
Vulval
ulceration
|
|
Narrow
|
A
|
Vulvovaginal
rash
|
|
Narrow
|
A
|
Vulvovaginal
ulceration
|
|
Narrow
|
A
|
Vulvovaginitis
allergic
|
|
Broad
|
A
|
Acute
respiratory failure
|
|
Broad
|
A
|
Administration
site photosensitivity reaction
|
|
Broad
|
A
|
Airway
remodelling
|
|
Broad
|
A
|
Allergy
to chemicals
|
|
Broad
|
A
|
Allergy
to fermented products
|
|
Broad
|
A
|
Alpha
tumour necrosis factor increased
|
|
Broad
|
A
|
Alveolitis
|
|
Broad
|
A
|
Antibody
test abnormal
|
|
Broad
|
A
|
Antibody
test positive
|
|
Broad
|
A
|
Anti-insulin
antibody increased
|
|
Broad
|
A
|
Anti-insulin
antibody positive
|
|
Broad
|
A
|
Anti-insulin
receptor antibody increased
|
|
Broad
|
A
|
Anti-insulin
receptor antibody positive
|
|
Broad
|
A
|
Application
site photosensitivity reaction
|
|
Broad
|
A
|
Asthma
|
|
Broad
|
A
|
Asthma
late onset
|
|
Broad
|
A
|
Asthma-chronic
obstructive pulmonary disease overlap syndrome
|
|
Broad
|
A
|
Asthmatic
crisis
|
|
Broad
|
A
|
Auricular
swelling
|
|
Broad
|
A
|
Blister
|
|
Broad
|
A
|
Blister
rupture
|
|
Broad
|
A
|
Blood
immunoglobulin A abnormal
|
|
Broad
|
A
|
Blood
immunoglobulin A increased
|
|
Broad
|
A
|
Blood
immunoglobulin D increased
|
|
Broad
|
A
|
Blood
immunoglobulin G abnormal
|
|
Broad
|
A
|
Blood
immunoglobulin G increased
|
|
Broad
|
A
|
Blood
immunoglobulin M abnormal
|
|
Broad
|
A
|
Blood
immunoglobulin M increased
|
|
Broad
|
A
|
Bronchial
hyperreactivity
|
|
Broad
|
A
|
Bronchial
oedema
|
|
Broad
|
A
|
Bullous
impetigo
|
|
Broad
|
A
|
Caffeine
allergy
|
|
Broad
|
A
|
Capillaritis
|
|
Broad
|
A
|
Charcot-Leyden
crystals
|
|
Broad
|
A
|
Cheilitis
|
|
Broad
|
A
|
Childhood
asthma
|
|
Broad
|
A
|
Choking
|
|
Broad
|
A
|
Choking
sensation
|
|
Broad
|
A
|
Complement
factor C1 decreased
|
|
Broad
|
A
|
Complement
factor C2 decreased
|
|
Broad
|
A
|
Complement
factor C3 decreased
|
|
Broad
|
A
|
Complement
factor C4 decreased
|
|
Broad
|
A
|
Complement
factor decreased
|
|
Broad
|
A
|
Conjunctivitis
|
|
Broad
|
A
|
Corneal
exfoliation
|
|
Broad
|
A
|
Cough
variant asthma
|
|
Broad
|
A
|
Cytokine
release syndrome
|
|
Broad
|
A
|
Cytokine
storm
|
|
Broad
|
A
|
Ear
swelling
|
|
Broad
|
A
|
Eosinophil
count abnormal
|
|
Broad
|
A
|
Eosinophil
count increased
|
|
Broad
|
A
|
Eosinophil
percentage abnormal
|
|
Broad
|
A
|
Eosinophil
percentage increased
|
|
Broad
|
A
|
Eosinophilia
|
|
Broad
|
A
|
Eosinophilia
myalgia syndrome
|
|
Broad
|
A
|
Eosinophilic
bronchitis
|
|
Broad
|
A
|
Eosinophilic
oesophagitis
|
|
Broad
|
A
|
Eosinophilic
pneumonia
|
|
Broad
|
A
|
Eosinophilic
pneumonia acute
|
|
Broad
|
A
|
Eosinophilic
pneumonia chronic
|
|
Broad
|
A
|
Erythema
|
|
Broad
|
A
|
Flushing
|
|
Broad
|
A
|
Gastrointestinal
oedema
|
|
Broad
|
A
|
Generalised
oedema
|
|
Broad
|
A
|
Genital
rash
|
|
Broad
|
A
|
Genital
swelling
|
|
Broad
|
A
|
Haemolytic
transfusion reaction
|
|
Broad
|
A
|
Human
leukocyte antigen marker study positive
|
|
Broad
|
A
|
Human
anti-hamster antibody increased
|
|
Broad
|
A
|
Human
anti-hamster antibody positive
|
|
Broad
|
A
|
Immune
complex level increased
|
|
Broad
|
A
|
Immunoglobulins
abnormal
|
|
Broad
|
A
|
Immunoglobulins
increased
|
|
Broad
|
A
|
Immunology
test abnormal
|
|
Broad
|
A
|
Implant
site photosensitivity
|
|
Broad
|
A
|
Infusion
site photosensitivity reaction
|
|
Broad
|
A
|
Injection
site panniculitis
|
|
Broad
|
A
|
Injection
site photosensitivity reaction
|
|
Broad
|
A
|
Interstitial
lung disease
|
|
Broad
|
A
|
Laryngeal
dyspnoea
|
|
Broad
|
A
|
Laryngeal
obstruction
|
|
Broad
|
A
|
Leukotriene
increased
|
|
Broad
|
A
|
Lip
exfoliation
|
|
Broad
|
A
|
Localised
oedema
|
|
Broad
|
A
|
Macrophage
inflammatory protein-1 alpha increased
|
|
Broad
|
A
|
Mechanical
urticaria
|
|
Broad
|
A
|
Medical
device site photosensitivity reaction
|
|
Broad
|
A
|
Mesenteric
panniculitis
|
|
Broad
|
A
|
Monocyte
chemotactic protein-2 increased
|
|
Broad
|
A
|
Mouth
ulceration
|
|
Broad
|
A
|
Mucocutaneous
ulceration
|
|
Broad
|
A
|
Mucosa
vesicle
|
|
Broad
|
A
|
Mucosal
erosion
|
|
Broad
|
A
|
Mucosal
exfoliation
|
|
Broad
|
A
|
Mucosal
necrosis
|
|
Broad
|
A
|
Mucosal
ulceration
|
|
Broad
|
A
|
Nasal
crease
|
|
Broad
|
A
|
Necrotising
panniculitis
|
|
Broad
|
A
|
Neurodermatitis
|
|
Broad
|
A
|
Neutralising
antibodies positive
|
|
Broad
|
A
|
Noninfective
conjunctivitis
|
|
Broad
|
A
|
Non-neutralising
antibodies positive
|
|
Broad
|
A
|
Occupational
asthma
|
|
Broad
|
A
|
Occupational
dermatitis
|
|
Broad
|
A
|
Oedema
mucosal
|
|
Broad
|
A
|
Oral
mucosal exfoliation
|
|
Broad
|
A
|
Orbital
oedema
|
|
Broad
|
A
|
Panniculitis
|
|
Broad
|
A
|
Penile
exfoliation
|
|
Broad
|
A
|
Penile
oedema
|
|
Broad
|
A
|
Penile
rash
|
|
Broad
|
A
|
Penile
swelling
|
|
Broad
|
A
|
Perineal
rash
|
|
Broad
|
A
|
Perivascular
dermatitis
|
|
Broad
|
A
|
Photosensitivity
reaction
|
|
Broad
|
A
|
Pneumonitis
|
|
Broad
|
A
|
Prurigo
|
|
Broad
|
A
|
Pruritus
|
|
Broad
|
A
|
Pulmonary
eosinophilia
|
|
Broad
|
A
|
Reactive
airways dysfunction syndrome
|
|
Broad
|
A
|
Respiratory
arrest
|
|
Broad
|
A
|
Respiratory
distress
|
|
Broad
|
A
|
Respiratory
failure
|
|
Broad
|
A
|
Respiratory
tract oedema
|
|
Broad
|
A
|
Reversible
airways obstruction
|
|
Broad
|
A
|
Rhinitis
perennial
|
|
Broad
|
A
|
Scrotal
exfoliation
|
|
Broad
|
A
|
Scrotal
swelling
|
|
Broad
|
A
|
Seasonal
allergy
|
|
Broad
|
A
|
Septal
panniculitis
|
|
Broad
|
A
|
Skin
erosion
|
|
Broad
|
A
|
Skin
exfoliation
|
|
Broad
|
A
|
Skin
oedema
|
|
Broad
|
A
|
Skin
swelling
|
|
Broad
|
A
|
Sneezing
|
|
Broad
|
A
|
Status
asthmaticus
|
|
Broad
|
A
|
Stomatitis
|
|
Broad
|
A
|
Streptokinase
antibody increased
|
|
Broad
|
A
|
Stridor
|
|
Broad
|
A
|
Suffocation
feeling
|
|
Broad
|
A
|
Sunscreen
sensitivity
|
|
Broad
|
A
|
Throat
tightness
|
|
Broad
|
A
|
Tongue
exfoliation
|
|
Broad
|
A
|
Tracheal
obstruction
|
|
Broad
|
A
|
Tracheostomy
|
|
Broad
|
A
|
Transplantation
associated food allergy
|
|
Broad
|
A
|
Upper
airway obstruction
|
|
Broad
|
A
|
Vaccination
site photosensitivity reaction
|
|
Broad
|
A
|
Vaginal
oedema
|
|
Broad
|
A
|
Visceral
oedema
|
|
Broad
|
A
|
Vulval
oedema
|
|
Broad
|
A
|
Vulvovaginal
exfoliation
|
|
Broad
|
A
|
Vulvovaginal
swelling
|
|
Broad
|
A
|
Wheezing
|
Abbreviations:
IV = intravenous; MedDRA = Medical Dictionary for Regulatory
Activities; SMQ = standardized MedDRA query.
a
This search was modified to remove terms associated with
the disease state being studied, including dermatitis atopic, eczema,
blepharitis allergic, blood immunoglobulin E increased,
conjunctivitis allergic, dermatitis, dermatitis acneiform, dermatitis
exfoliative, dermatitis exfoliative generalized, dermatitis infected,
eye allergy, Kaposi’s varicelliform eruption, multiple
allergies, perioral dermatitis, rhinitis allergic, and vulval eczema.
Table
4. Standardized MedDRA Angioedema Query (SMQ) and Anaphylactic Query
(SMQ) Preferred Terms2
|
|
|
|
|
|
|
|
Angioedema
SMQ (20000024)
|
Anaphylactic
reaction SMQ (20000021)a
|
|
Search
Type
|
Category
|
Preferred
Term
|
Search
Type
|
Category
|
Preferred
Term
|
|
Narrow
|
A
|
Acquired
C1 inhibitor deficiency
|
Narrow
|
A
|
Anaphylactic
reaction
|
|
Narrow
|
A
|
Allergic
oedema
|
Narrow
|
A
|
Anaphylactic
shock
|
|
Narrow
|
A
|
Angioedema
|
Narrow
|
A
|
Anaphylactic
transfusion reaction
|
|
Narrow
|
A
|
Circumoral
oedema
|
Narrow
|
A
|
Anaphylactoid
reaction
|
|
Narrow
|
A
|
Circumoral
swelling
|
Narrow
|
A
|
Anaphylactoid
shock
|
|
Narrow
|
A
|
Conjunctival
oedema
|
Narrow
|
A
|
Circulatory
collapse
|
|
Narrow
|
A
|
Corneal
oedema
|
Narrow
|
A
|
Dialysis
membrane reaction
|
|
Narrow
|
A
|
Epiglottic
oedema
|
Narrow
|
A
|
Kounis
syndrome
|
|
Narrow
|
A
|
Eye
oedema
|
Narrow
|
A
|
Procedural
shock
|
|
Narrow
|
A
|
Eye
swelling
|
Narrow
|
A
|
Shock
|
|
Narrow
|
A
|
Eyelid
oedema
|
Narrow
|
A
|
Shock
symptom
|
|
Narrow
|
A
|
Face
oedema
|
Narrow
|
A
|
Type
I hypersensitivity
|
|
Narrow
|
A
|
Gingival
oedema
|
Broad
|
B
|
Acute
respiratory failure
|
|
Narrow
|
A
|
Gingival
swelling
|
Broad
|
B
|
Asthma
|
|
Narrow
|
A
|
Gleich's
syndrome
|
Broad
|
B
|
Bronchial
oedema
|
|
Narrow
|
A
|
Hereditary
angioedema
|
Broad
|
B
|
Bronchospasm
|
|
Narrow
|
A
|
Hereditary
angioedema with C1 esterase inhibitor deficiency
|
Broad
|
B
|
Cardio-respiratory
distress
|
|
Narrow
|
A
|
Idiopathic
angioedema
|
Broad
|
B
|
Chest
discomfort
|
|
Narrow
|
A
|
Idiopathic
urticaria
|
Broad
|
B
|
Choking
|
|
Narrow
|
A
|
Intestinal
angioedema
|
Broad
|
B
|
Choking
sensation
|
|
Narrow
|
A
|
Laryngeal
oedema
|
Broad
|
B
|
Circumoral
oedema
|
|
Narrow
|
A
|
Laryngotracheal
oedema
|
Broad
|
B
|
Cough
|
|
Narrow
|
A
|
Limbal
swelling
|
Broad
|
B
|
Cough
variant asthma
|
|
Narrow
|
A
|
Lip
oedema
|
Broad
|
B
|
Cyanosis
|
|
Narrow
|
A
|
Lip
swelling
|
Broad
|
B
|
Dyspnoea
|
|
Narrow
|
A
|
Mouth
swelling
|
Broad
|
B
|
Hyperventilation
|
|
Narrow
|
A
|
Oculorespiratory
syndrome
|
Broad
|
B
|
Irregular
breathing
|
|
Narrow
|
A
|
Oedema
mouth
|
Broad
|
B
|
Laryngeal
dyspnoea
|
|
Narrow
|
A
|
Oropharyngeal
oedema
|
Broad
|
B
|
Laryngeal
oedema
|
|
Narrow
|
A
|
Oropharyngeal
swelling
|
Broad
|
B
|
Laryngospasm
|
|
Narrow
|
A
|
Palatal
oedema
|
Broad
|
B
|
Laryngotracheal
oedema
|
|
Narrow
|
A
|
Palatal
swelling
|
Broad
|
B
|
Mouth
swelling
|
|
Narrow
|
A
|
Periorbital
oedema
|
Broad
|
B
|
Nasal
obstruction
|
|
Narrow
|
A
|
Periorbital
swelling
|
Broad
|
B
|
Oedema
mouth
|
|
Narrow
|
A
|
Pharyngeal
oedema
|
Broad
|
B
|
Oropharyngeal
oedema
|
|
Narrow
|
A
|
Pharyngeal
swelling
|
Broad
|
B
|
Oropharyngeal
spasm
|
|
Narrow
|
A
|
Scleral
oedema
|
Broad
|
B
|
Oropharyngeal
swelling
|
|
Narrow
|
A
|
Swelling
face
|
Broad
|
B
|
Pharyngeal
oedema
|
|
Narrow
|
A
|
Swelling
of eyelid
|
Broad
|
B
|
Pharyngeal
swelling
|
|
Narrow
|
A
|
Swollen
tongue
|
Broad
|
B
|
Respiratory
arrest
|
|
Narrow
|
A
|
Tongue
oedema
|
Broad
|
B
|
Respiratory
distress
|
|
Narrow
|
A
|
Tracheal
oedema
|
Broad
|
B
|
Respiratory
failure
|
|
Narrow
|
A
|
Urticaria
|
Broad
|
B
|
Reversible
airways obstruction
|
|
Narrow
|
A
|
Urticaria
cholinergic
|
Broad
|
B
|
Sensation
of foreign body
|
|
Narrow
|
A
|
Urticaria
chronic
|
Broad
|
B
|
Sneezing
|
|
Narrow
|
A
|
Urticaria
papular
|
Broad
|
B
|
Stridor
|
|
Broad
|
A
|
Auricular
swelling
|
Broad
|
B
|
Swollen
tongue
|
|
Broad
|
A
|
Breast
oedema
|
Broad
|
B
|
Tachypnoea
|
|
Broad
|
A
|
Breast
swelling
|
Broad
|
B
|
Throat
tightness
|
|
Broad
|
A
|
Choking
|
Broad
|
B
|
Tongue
oedema
|
|
Broad
|
A
|
Choking
sensation
|
Broad
|
B
|
Tracheal
obstruction
|
|
Broad
|
A
|
Drug
hypersensitivity
|
Broad
|
B
|
Tracheal
oedema
|
|
Broad
|
A
|
Ear
swelling
|
Broad
|
B
|
Upper
airway obstruction
|
|
Broad
|
A
|
Endotracheal
intubation
|
Broad
|
B
|
Wheezing
|
|
Broad
|
A
|
Gastrointestinal
oedema
|
Broad
|
C
|
Acquired
C1 inhibitor deficiency
|
|
Broad
|
A
|
Generalised
oedema
|
Broad
|
C
|
Allergic
oedema
|
|
Broad
|
A
|
Genital
swelling
|
Broad
|
C
|
Angioedema
|
|
Broad
|
A
|
Hypersensitivity
|
Broad
|
C
|
Circumoral
swelling
|
|
Broad
|
A
|
Laryngeal
dyspnoea
|
Broad
|
C
|
Erythema
|
|
Broad
|
A
|
Laryngeal
obstruction
|
Broad
|
C
|
Eye
oedema
|
|
Broad
|
A
|
Localised
oedema
|
Broad
|
C
|
Eye
pruritus
|
|
Broad
|
A
|
Nasal
obstruction
|
Broad
|
C
|
Eye
swelling
|
|
Broad
|
A
|
Nasal
oedema
|
Broad
|
C
|
Eyelid
oedema
|
|
Broad
|
A
|
Nipple
oedema
|
Broad
|
C
|
Face
oedema
|
|
Broad
|
A
|
Nipple
swelling
|
Broad
|
C
|
Flushing
|
|
Broad
|
A
|
Obstructive
airways disorder
|
Broad
|
C
|
Hereditary
angioedema with C1 esterase inhibitor deficiency
|
|
Broad
|
A
|
Oedema
|
Broad
|
C
|
Injection
site urticaria
|
|
Broad
|
A
|
Oedema
blister
|
Broad
|
C
|
Lip
oedema
|
|
Broad
|
A
|
Oedema
genital
|
Broad
|
C
|
Lip
swelling
|
|
Broad
|
A
|
Oedema
mucosal
|
Broad
|
C
|
Nodular
rash
|
|
Broad
|
A
|
Oedema
neonatal
|
Broad
|
C
|
Ocular
hyperaemia
|
|
Broad
|
A
|
Oedema
peripheral
|
Broad
|
C
|
Oedema
|
|
Broad
|
A
|
Orbital
oedema
|
Broad
|
C
|
Oedema
blister
|
|
Broad
|
A
|
Penile
oedema
|
Broad
|
C
|
Periorbital
oedema
|
|
Broad
|
A
|
Penile
swelling
|
Broad
|
C
|
Periorbital
swelling
|
|
Broad
|
A
|
Perinephric
oedema
|
Broad
|
C
|
Pruritus
|
|
Broad
|
A
|
Peripheral
oedema neonatal
|
Broad
|
C
|
Pruritus
allergic
|
|
Broad
|
A
|
Peripheral
swelling
|
Broad
|
C
|
Rash
|
|
Broad
|
A
|
Reversible
airways obstruction
|
Broad
|
C
|
Rash
erythematous
|
|
Broad
|
A
|
Scrotal
oedema
|
Broad
|
C
|
Rash
pruritic
|
|
Broad
|
A
|
Scrotal
swelling
|
Broad
|
C
|
Skin
swelling
|
|
Broad
|
A
|
Skin
oedema
|
Broad
|
C
|
Swelling
|
|
Broad
|
A
|
Skin
swelling
|
Broad
|
C
|
Swelling
face
|
|
Broad
|
A
|
Soft
tissue swelling
|
Broad
|
C
|
Swelling
of eyelid
|
|
Broad
|
A
|
Stridor
|
Broad
|
C
|
Urticaria
|
|
Broad
|
A
|
Suffocation
feeling
|
Broad
|
C
|
Urticaria
papular
|
|
Broad
|
A
|
Swelling
|
Broad
|
D
|
Blood
pressure decreased
|
|
Broad
|
A
|
Therapeutic
product cross-reactivity
|
Broad
|
D
|
Blood
pressure diastolic decreased
|
|
Broad
|
A
|
Throat
tightness
|
Broad
|
D
|
Blood
pressure systolic decreased
|
|
Broad
|
A
|
Tracheal
obstruction
|
Broad
|
D
|
Cardiac
arrest
|
|
Broad
|
A
|
Tracheostomy
|
Broad
|
D
|
Cardio-respiratory
arrest
|
|
Broad
|
A
|
Type
I hypersensitivity
|
Broad
|
D
|
Cardiovascular
insufficiency
|
|
Broad
|
A
|
Upper
airway obstruction
|
Broad
|
D
|
Diastolic
hypotension
|
|
Broad
|
A
|
Vaginal
oedema
|
Broad
|
D
|
Hypotension
|
|
Broad
|
A
|
Visceral
oedema
|
Broad
|
D
|
Hypotensive
crisis
|
|
Broad
|
A
|
Vulval
oedema
|
Broad
|
D
|
Post
procedural hypotension
|
|
Broad
|
A
|
Vulvovaginal
swelling
|
Broad
|
C
|
Acquired
C1 inhibitor deficiency
|
|
Broad
|
A
|
Wheezing
|
NA
|
NA
|
NA
|
Abbreviations:
MedDRA = Medical Dictionary for Regulatory Activities; NA = not
applicable; SMQ = standardized MedDRA query.
a
Anaphylactic algorithm was defined as 1 or more events
in the following categories a narrow term from the anaphylactic SMQ
(Category A of the SMQ), or multiple terms from the SMQ,
comprising terms from at least 2 of the following categories from the
SMQ: Category B - (Upper Airway/Respiratory signs and symptoms)
Category C - (Angioedema/Urticaria/Pruritus/Flush signs and
symptoms), and Category D - (Cardiovascular/Hypotension signs and
symptoms).
References
1.
Olumiant [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
2.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3.
Tham EH, Leung DY. Mechanisms by which atopic dermatitis predisposes
to food allergy and the atopic march. Allergy Asthma Immunol Res.
2019;11(1):4-15. https://doi.org/10.4168/aair.2019.11.1.4
Glossary
AD =
atopic dermatitis
BARI
= baricitinib
Ig =
immunoglobulin
MedDRA
= Medical Dictionary for Regulatory Activities
SMQ
= standardized MedDRA query
TEAE
= treatment-emergent adverse event
▼ This
medicinal product is subject to additional monitoring. This will
allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions.