Trial Outcomes & Findings for Study of Adalimumab (HUMIRA®) in Patients With Moderate to Severe Psoriasis (PS) in Spain (PROMISE) (NCT NCT01076192)
NCT ID: NCT01076192
Last Updated: 2016-01-06
Results Overview
PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A lower (and negative) value of change indicates an increase in the severity of the psoriasis, while a positive value indicates an improvement in the severity of the PS. Missing data were imputed using last observation carried forward (LOCF).
Recruitment status
COMPLETED
Target enrollment
547 participants
Primary outcome timeframe
Baseline, month 1 and every 3 months the first year and every 6 months up to month 24
Results posted on
2016-01-06
Participant Flow
A total of 547 subjects were enrolled: 532 in the ITT population were analyzed for efficacy (excluding 15 for lack of follow-up visits (n=8), non-fulfillment of the criteria of moderate to severe PS (n=6) and failure to initiate treatment at the baseline visit (n=1)); 542 were analyzed for safety (excluding 5 due to lack of evaluable safety data).
Participant milestones
| Measure |
Moderate-to-severe Chronic Plaque Psoriasis
Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
|
|---|---|
|
Overall Study
STARTED
|
547
|
|
Overall Study
COMPLETED
|
350
|
|
Overall Study
NOT COMPLETED
|
197
|
Reasons for withdrawal
| Measure |
Moderate-to-severe Chronic Plaque Psoriasis
Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
|
|---|---|
|
Overall Study
Other
|
197
|
Baseline Characteristics
Study of Adalimumab (HUMIRA®) in Patients With Moderate to Severe Psoriasis (PS) in Spain (PROMISE)
Baseline characteristics by cohort
| Measure |
Moderate-to-severe Chronic Plaque Psoriasis
n=532 Participants
Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
|
|---|---|
|
Age, Continuous
|
46.48 years
STANDARD_DEVIATION 13.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
206 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
326 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24Population: Efficacy analyses included all participants who received at least 1 dose of adalimumab and had at least one follow-up visit (ITT) with evaluable data.
PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A lower (and negative) value of change indicates an increase in the severity of the psoriasis, while a positive value indicates an improvement in the severity of the PS. Missing data were imputed using last observation carried forward (LOCF).
Outcome measures
| Measure |
Moderate-to-severe Chronic Plaque Psoriasis
n=528 Participants
Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
|
|---|---|
|
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI)
Month 1
|
8.39 units on a scale
Standard Deviation 7.43
|
|
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI)
Month 3
|
11.30 units on a scale
Standard Deviation 8.84
|
|
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI)
Month 6
|
11.52 units on a scale
Standard Deviation 9.41
|
|
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI)
Month 9
|
11.32 units on a scale
Standard Deviation 9.53
|
|
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI)
Month 12
|
11.21 units on a scale
Standard Deviation 9.67
|
|
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI)
Month 18
|
10.93 units on a scale
Standard Deviation 9.77
|
|
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI)
Month 24
|
10.91 units on a scale
Standard Deviation 9.78
|
PRIMARY outcome
Timeframe: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24Population: Efficacy analyses included ITT population with evaluable data.
PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.
Outcome measures
| Measure |
Moderate-to-severe Chronic Plaque Psoriasis
n=526 Participants
Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
|
|---|---|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50)
Month 1
|
58.4 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50)
Month 3
|
80.6 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50)
Month 6
|
80.8 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50)
Month 9
|
80.6 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50)
Month 12
|
79.5 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50)
Month 18
|
76.8 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50)
Month 24
|
77.4 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24Population: Efficacy analyses included ITT population with evaluable data.
PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.
Outcome measures
| Measure |
Moderate-to-severe Chronic Plaque Psoriasis
n=526 Participants
Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
|
|---|---|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75)
Month 9
|
65.8 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75)
Month 12
|
64.6 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75)
Month 18
|
63.7 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75)
Month 24
|
64.4 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75)
Month 1
|
29.8 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75)
Month 3
|
64.8 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75)
Month 6
|
66.9 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24Population: Efficacy analyses included ITT population with evaluable data.
PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.
Outcome measures
| Measure |
Moderate-to-severe Chronic Plaque Psoriasis
n=526 Participants
Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
|
|---|---|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90)
Month 24
|
47.1 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90)
Month 1
|
11.4 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90)
Month 3
|
43.3 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90)
Month 6
|
49.8 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90)
Month 9
|
47.5 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90)
Month 12
|
48.3 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90)
Month 18
|
46.4 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24Population: Efficacy analyses included ITT population with evaluable data.
PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 100 response is the percentage of participants who achieved a 100% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.
Outcome measures
| Measure |
Moderate-to-severe Chronic Plaque Psoriasis
n=526 Participants
Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
|
|---|---|
|
Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100)
Month 12
|
33.8 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100)
Month 1
|
6.1 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100)
Month 3
|
29.3 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100)
Month 6
|
33.1 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100)
Month 9
|
33.5 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100)
Month 18
|
32.7 percentage of participants
|
|
Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100)
Month 24
|
32.7 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24Population: Efficacy analyses included ITT population with evaluable data.
Body Surface Area (BSA) affected or the psoriasis area is determined by the direct calculation of the affected body surface area. This determination was used to evaluate the effectiveness of the treatment during each of the study visits. The change was calculated by deducting the final score from the baseline score. Increased scores correspond to reduction of severity and reduction of BSA. Missing data were imputed using LOCF.
Outcome measures
| Measure |
Moderate-to-severe Chronic Plaque Psoriasis
n=509 Participants
Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
|
|---|---|
|
Mean Change From Baseline in Body Surface Area (BSA) Affected
Month 6
|
18.86 percentage of body surface area
Standard Deviation 19.58
|
|
Mean Change From Baseline in Body Surface Area (BSA) Affected
Month 1
|
11.24 percentage of body surface area
Standard Deviation 15.51
|
|
Mean Change From Baseline in Body Surface Area (BSA) Affected
Month 3
|
17.86 percentage of body surface area
Standard Deviation 18.43
|
|
Mean Change From Baseline in Body Surface Area (BSA) Affected
Month 9
|
18.75 percentage of body surface area
Standard Deviation 19.73
|
|
Mean Change From Baseline in Body Surface Area (BSA) Affected
Month 12
|
18.62 percentage of body surface area
Standard Deviation 19.63
|
|
Mean Change From Baseline in Body Surface Area (BSA) Affected
Month 18
|
18.04 percentage of body surface area
Standard Deviation 19.76
|
|
Mean Change From Baseline in Body Surface Area (BSA) Affected
Month 24
|
18.18 percentage of body surface area
Standard Deviation 20.08
|
PRIMARY outcome
Timeframe: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24Population: Efficacy analyses included ITT population with evaluable data.
The PGA was used to measure participants' disease status at the time of assessment. This tool is a horizontal visual analogue 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). The percentage of patients who showed an improvement from baseline in their PGA scores is presented. Missing data were imputed using LOCF.
Outcome measures
| Measure |
Moderate-to-severe Chronic Plaque Psoriasis
n=530 Participants
Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
|
|---|---|
|
Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA)
Month 1
|
71.9 percentage of participants
|
|
Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA)
Month 3
|
85.3 percentage of participants
|
|
Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA)
Month 6
|
82.6 percentage of participants
|
|
Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA)
Month 9
|
83.0 percentage of participants
|
|
Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA)
Month 12
|
81.3 percentage of participants
|
|
Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA)
Month 18
|
79.4 percentage of participants
|
|
Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA)
Month 24
|
79.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and every 6 months up to month 24Population: Efficacy analyses included ITT population with evaluable data.
DLQI is a self-administered Health Related Quality of Life (HRQL) questionnaire specifically for patients with dermatological diseases, adapted and validated in the Spanish population. It consists of 10 items with a Likert response scale for 4 categories and uses a 7 day time reference. It generates a global score that ranges from 0 (better HRQL) to 30 (worse HRQL) points. Change in DLQI was calculated by deducting the final score from the baseline score. Missing data were imputed using LOCF.
Outcome measures
| Measure |
Moderate-to-severe Chronic Plaque Psoriasis
n=504 Participants
Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
|
|---|---|
|
Mean Change From Baseline in Dermatology Life Quality Index (DLQI)
Month 6
|
5.83 units on a scale
Standard Deviation 6.95
|
|
Mean Change From Baseline in Dermatology Life Quality Index (DLQI)
Month 12
|
6.17 units on a scale
Standard Deviation 7.12
|
|
Mean Change From Baseline in Dermatology Life Quality Index (DLQI)
Month 18
|
6.05 units on a scale
Standard Deviation 7.31
|
|
Mean Change From Baseline in Dermatology Life Quality Index (DLQI)
Month 24
|
5.99 units on a scale
Standard Deviation 7.43
|
SECONDARY outcome
Timeframe: Baseline and every 6 months up to month 24Population: Analysis included ITT population with evaluable data.
The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state. Missing data were imputed using LOCF.
Outcome measures
| Measure |
Moderate-to-severe Chronic Plaque Psoriasis
n=453 Participants
Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
|
|---|---|
|
Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS)
Month 6
|
-10.79 units on a scale
Standard Deviation 21.75
|
|
Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS)
Month 12
|
-12.27 units on a scale
Standard Deviation 22.92
|
|
Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS)
Month 18
|
-12.91 units on a scale
Standard Deviation 23.45
|
|
Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS)
Month 24
|
-12.71 units on a scale
Standard Deviation 23.71
|
SECONDARY outcome
Timeframe: Baseline and every 6 months up to month 24Population: Analysis included ITT population with evaluable data.
WPAI-SHP is a questionnaire used to evaluate lost productivity. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. Increased (positive) scores correspond to a reduction in the percentage of lost work productivity. Missing data were imputed using LOCF. n=the number of participants with data at each time point.
Outcome measures
| Measure |
Moderate-to-severe Chronic Plaque Psoriasis
n=251 Participants
Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
|
|---|---|
|
Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)
Month 6 (n=180)
|
10.61 units on a scale (a derived score)
Standard Deviation 24.97
|
|
Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)
Month 12 (n=145)
|
9.86 units on a scale (a derived score)
Standard Deviation 24.55
|
|
Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)
Month 18 (n=137)
|
12.63 units on a scale (a derived score)
Standard Deviation 25.39
|
|
Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)
Month 24 (n=121)
|
12.89 units on a scale (a derived score)
Standard Deviation 21.93
|
SECONDARY outcome
Timeframe: From time of informed consent to the final visit after 2 years of observationPopulation: Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
AESIs are adverse events of special interest, including infection, neoplasm, lupus-like, demyelinating disease, serious hepatic and/or haematological event.
Outcome measures
| Measure |
Moderate-to-severe Chronic Plaque Psoriasis
n=542 Participants
Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
|
|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Cerebrovascular accident
|
2 participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Haematological event
|
1 participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Hepatic event
|
1 participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Congestive heart failure
|
1 participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Opportunistic infections
|
30 participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Lupus-like syndrome
|
1 participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Neoplasm
|
11 participants
|
SECONDARY outcome
Timeframe: From time of informed consent to the final visit after 2 years of observationPopulation: Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
SAEs are adverse event with any of the following severity criteria: Potentially fatal/endangers life, Hospitalisation or prolonging of hospitalisation, a medically important event that requires medical or surgical intervention to prevent a serious outcome, Disability or persistent incapacitation, death, congenital anomalies and/or miscarriage or abortion. See the Reported Adverse Events Section for more details.
Outcome measures
| Measure |
Moderate-to-severe Chronic Plaque Psoriasis
n=542 Participants
Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
|
|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
24 participants
|
Adverse Events
Moderate-to-severe Chronic Plaque Psoriasis
Serious events: 24 serious events
Other events: 314 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Moderate-to-severe Chronic Plaque Psoriasis
n=542 participants at risk
Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodisplastic syndrome
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Haemorrhage of the digestive tract
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Death
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Blood and lymphatic system disorders
Ferropenic anaemia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
Lacunar stroke
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
Headache
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Generalized weakness
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Vascular disorders
Hypertension
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
Vertigo
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Tuberculous meningitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
acute pancreatitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
outbreak of psoriasis
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
subarachnoid haemorrhage after traumatic injury without mention of open intracraneal wound
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Renal and urinary disorders
ureterohydronephrosis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
basocellular carcinoma
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
squamous cell carcinoma of the lungs
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Respiratory, thoracic and mediastinal disorders
tonsil hypertrophy
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
scrotal abscess
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
clear cell carcinoma of the kidneys
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
chest pain
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Vascular disorders
arterial hypertension
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Cardiac disorders
myocardial infarction
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Cardiac disorders
class iii heart failure
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
neurosensory hypoacusia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Cardiac disorders
unstable angina
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
psoriatic arthritis
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
salmonellosis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
astrocytoma
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
invasive breast duct cancer
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Surgical and medical procedures
arthrodesis of the toe
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
facial paralysis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
alcoholic pancreatitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Surgical and medical procedures
cardiac ablation
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Cardiac disorders
non-specific tachycardia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
acute gastric ulcer with haemorrhage
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
angioedema
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
spondylarthropathy
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
psoriatic arthopathy
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Reproductive system and breast disorders
ovarian benign germ cell teratoma
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
suppurative hydradenitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
sebaceous cyst
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Cardiac disorders
complete auriculoventricular blockage
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Respiratory, thoracic and mediastinal disorders
allergic bronchitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory insufficiency
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
multiorganic failure
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
malignant neoplasms of the sigmoid colon
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
adenocarcinoma of the breast
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Psychiatric disorders
state of confusion
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
tension headache
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
non-specific chest pain
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Vascular disorders
deep vein thrombosis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
hepatic carcinoma
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
adenocarcinoma of the colon
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Surgical and medical procedures
radical prostatectomy
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Surgical and medical procedures
abortion
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Pregnancy, puerperium and perinatal conditions
unwanted pregnancy
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
community-acquired pneumonia
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Immune system disorders
sarcoidosis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Surgical and medical procedures
tonsillectomy
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
peritonsillar abscess
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
worsening of psoriasis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Respiratory, thoracic and mediastinal disorders
exacerbation of copd
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
septic arthritis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Immune system disorders
lupus-like syndrome
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Metabolism and nutrition disorders
steroid-induced diabetes
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
pulmonary tuberculosis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
sepsis caused by methicillin-resistant staphylococcus aureus
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Immune system disorders
autoimmune hepatitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
infection by cytomegalovirus
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Pregnancy, puerperium and perinatal conditions
miscarriage
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Pregnancy, puerperium and perinatal conditions
ectopic pregnancy
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
chrohn ileocolitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
adenocarcinoma
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
bronchial carcinoma, stage iv
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Blood and lymphatic system disorders
leukocytosis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Blood and lymphatic system disorders
lymphocytosis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Surgical and medical procedures
hysterectomy
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Psychiatric disorders
anxiety
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Ear and labyrinth disorders
vertigo syndromes and non-specific labyrinth disorders
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
erysipela
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
chronic myelogenous leukaemia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
carcinoma with unknown primary tumour
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Blood and lymphatic system disorders
cervical lymphadenopathy
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
bacterial pyelonephritis
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Injury, poisoning and procedural complications
motorcycle accident
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Injury, poisoning and procedural complications
comminuted fracture
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Injury, poisoning and procedural complications
dislocated hip
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
femur fracture
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Injury, poisoning and procedural complications
torn anterior cruciate ligament
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Surgical and medical procedures
bariatric surgery
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
septic shock
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Cardiac disorders
acute myocardial infarction of the inferoposterior wall
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
pustular psoriasis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
urothelial carcinoma
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung metastasis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
bone metastasis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
respiratory infection
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
infection by Escherichia coli
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
enterococcus bacteraemia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
septicaemia by candida
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
normal nuclear magnetic resonance imaging
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
oesophageal erosion
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Metabolism and nutrition disorders
hypertriglyceridaemia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
Other adverse events
| Measure |
Moderate-to-severe Chronic Plaque Psoriasis
n=542 participants at risk
Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Abdominal pain not otherwise specified
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Abnormal cholesterol in blood
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Abnormal gamma-glutamyl transferase
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Abnormal glucose
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Abnormal glutamate-pyruvate transaminase
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Abnormal uric acid in blood
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Blood and lymphatic system disorders
Abnormal erythrocytes
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Reproductive system and breast disorders
Abnormal menstruation
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Abdominal abscess
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Abnormal triglycerides
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Abnormal triglycerides in blood
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Abscess on a limb
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Abscess on the back
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Achilles tendinitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Acute bronchitis
|
0.74%
4/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Acute ear infection
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Acute gastroenteritis
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Acute pharyngitis
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Acute sinusitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Acute tonsillitis
|
1.7%
9/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Acute urticaria
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic bronchitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Immune system disorders
Allergic reaction
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Immune system disorders
Allergy to insect stings
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Anal pain
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiomyolipoma
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Ankle pain
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Psychiatric disorders
Anxiety
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Psychiatric disorders
Anxiety attack
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Arm pain
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Vascular disorders
Arterial hypertension
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Articular inflammation
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Asthenia
|
0.74%
4/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic bronchitis
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Athlete's foot
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Cardiac disorders
Atrial fibrillation
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Average corpuscle volume
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Axillary abscess
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Reproductive system and breast disorders
Balanitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basocellular carcinoma
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Hepatobiliary disorders
Biliar colic
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Eye disorders
Blepharitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Boil
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Bone oedema
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Bronchiolitis caused by respiratory syncytial virus
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.92%
5/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Cervical pain
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Blood and lymphatic system disorders
Cervical lymphadenopathy
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Cervicalgia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Chest pain
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Cardiac disorders
Chest pain during exertion
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Hepatobiliary disorders
Cholestasis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Hepatobiliary disorders
Chronic hepatitis C
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Ear and labyrinth disorders
Chronic nodular chondrodermatitis helicis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Renal and urinary disorders
Chronic renal insufficiency
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Surgical and medical procedures
Circumcision
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Cold
|
3.7%
20/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Common cold
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Common cold syndrome
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
Compressive neuropathy
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Condylomata
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Condylomata acuminata
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Eye disorders
Conjunctivitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Cardiac disorders
Coronary artery calcification
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Cutaneous erythema
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Psychiatric disorders
Decline
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Cardiac disorders
Decompensated heart failure
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Metabolism and nutrition disorders
Decompensated diabetes
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Decreased platelets
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Metabolism and nutrition disorders
Deficit of vitamin B12
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Injury, poisoning and procedural complications
Dental fracture
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Surgical and medical procedures
Dental implant
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Dental infection
|
0.92%
5/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Psychiatric disorders
Depression
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Determination of C1Q
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Metabolism and nutrition disorders
Diabetes mellitus Type-2
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
6/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Dishydrotic eczema
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
Dizziness
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Dorsalgia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
Drowsiness
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Hepatobiliary disorders
Drug-induced liver disease
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Dry mouth
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Cardiac disorders
Dyspnea
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Renal and urinary disorders
Dysuria
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Ear and labyrinth disorders
Earache
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Eczema of the eyelids
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Elevated alpha-fetoprotein
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Elevated amylase
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Elevated average corpuscle volume
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Elevated creatinine
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Elevated ferritin in plasma
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Elevated glutamate oxaloacetate transaminase
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Elevated glutamate-pyruvate transaminase
|
0.92%
5/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Elevated high-density lipoprotein
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Elevated lipase
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Elevated triglycerides
|
1.1%
6/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Elevated gammaglobulin
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Elevated transaminases
|
0.92%
5/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Elevation of creatine phosphokinase
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Elevation of gamma-glutamyl transferase
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Enthesitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epidermal cyst
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Reproductive system and breast disorders
Epididimoorquitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Epigastralgia
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Epigastric pain
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
Epileptic crisis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Reproductive system and breast disorders
Erectile impotence
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Erosive gastritis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Exacerbation of psoriasis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Eye disorders
Excessive tearing
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Exhaustion
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Surgical and medical procedures
Extraction of wisdom tooth
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Eye disorders
Eye discomfort
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Face cellulitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
Facial paralysis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Facial rash
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Injury, poisoning and procedural complications
Falls
|
0.92%
5/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Blood and lymphatic system disorders
Ferropenic anaemia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Fever
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Flu
|
2.4%
13/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Foot cellulitis
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Injury, poisoning and procedural complications
Fractured metatarsal
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Functional dyspepsia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Furunculosis
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Gastritis caused by helicobacter pylori
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
General discomfort
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Generalised rash
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Genital candidiasis
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Genital wart
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Gingivitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Eye disorders
Glare
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Eye disorders
Glaucoma
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Gonalgia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Granulomatous lesion
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
Headache
|
1.3%
7/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Heel pain
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Heel spur
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.92%
5/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Herniated disc
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Herpes simplex
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Herpes zoster
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
High cholesterol
|
1.7%
9/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Hormonal imbalance
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Reproductive system and breast disorders
Hydrocele
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.92%
5/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.74%
4/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Vascular disorders
Hypertension attack
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
1.8%
10/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.2%
12/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.74%
4/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Endocrine disorders
Hypothyroidism
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Increase in size of submaxillar gland
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Increased low-density lipoprotein
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Increased C-Reactive Protein
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Increased average corpuscular haemoglobin
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Increased bilirubin
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Increased creatine phosphokinase
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Increased gamma-glutamyl transferase
|
0.74%
4/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Increased rheumatoid factor
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Increased serum glutamate-pyruvate transaminase
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Increased urea in blood
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Increased Hepatitis B viral load
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Increased vertical sleeve gastrectomy
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Ineffective drug
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected cyst
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected sebaceous cyst
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Infection by blastocystis hominis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Infection of upper airways not otherwise specified
|
3.1%
17/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Ear and labyrinth disorders
Inflammation of the middle ear
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Inguinal abscess
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
Insomnia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
Instability
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal polyp
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Injury, poisoning and procedural complications
Intoxication by immunosuppressants
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Irritable bowel
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Irritation of the palate
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Itching in the injection zone
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Joint paint with involvement of the lower leg
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Labial herpes
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Latent tuberculosis
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Leg cellulitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Leukoplakia of the oral mucosa (incl. tongue)
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Loss of dental piece
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Low folic acid
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
0.92%
5/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Low-grade fever
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Immune system disorders
Lupus-like syndrome
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Blood and lymphatic system disorders
Macrocytosis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Mandibular osteomyelitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Blood and lymphatic system disorders
Megaloblastic anaemia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Metabolism and nutrition disorders
Metabolic syndrome
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Navicular fractures
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Negative tuberculosis test
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Non-specific chest pain
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Non-specific middle ear function
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Viral infection not otherwise specified
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Odynophagia
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Oedema of the face
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Oedema of the feet
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Oedema of the leg
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Oedema of the limbs
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Oedema of the lower limbs
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Onphalitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Ophthalmological herpes simplex
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Oral infection
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthrosis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Osteoarticular pain
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Outbreak of psoriasis
|
5.0%
27/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Outer ear infection
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Pain at the puncture location
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Pain in hand
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Pain in lower limbs
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Pain in molars
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Pain in the injection zone
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Painful knees
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Painful tongue
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar pustulosis
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Cardiac disorders
Palpitations
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Paradoxical reaction to a drug
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
Paraesthesia in limbs
|
0.74%
4/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Paronychia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Cardiac disorders
Paroxistic tachycardia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Penile candidiasis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Perianal abscess
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Pharyngitis
|
2.6%
14/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Pharyngitis not otherwise specified
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Pharyngoamygdalitis
|
1.3%
7/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Vascular disorders
Phlebitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Surgical and medical procedures
Photocoagulation
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Eye disorders
Photophobia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Pneumonia
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Reproductive system and breast disorders
Polymenorrhea
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Renal and urinary disorders
Polyuria
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Positive antinuclear antibodies
|
1.7%
9/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Positive cutaneous tuberculosis test
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Positive lupus anticoagulant
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Positive tuberculosis test
|
0.92%
5/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Eye disorders
Posterior detachment of the vitreous humour
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Post-surgical pain
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Eye disorders
Pseudopterigion
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Psoriasis guttata
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Psoriasis of the scalp
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthopathy
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthritis
|
1.3%
7/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary consolidation
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Purulent secretion
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Vascular disorders
Raynaud's disease
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Reaction at injection site
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Rectorrhage
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Psychiatric disorders
Reduced sex drive
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Renal and urinary disorders
Renal colic
|
0.92%
5/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Surgical and medical procedures
Renal lithotripsy
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Respiratory infection
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Immune system disorders
Rheumatic polymyalgia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Rib fracture
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Surgical and medical procedures
Root canal
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
Sciatic
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Scrotal abscess
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Vascular disorders
Senile purpura
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Sinusitis
|
0.74%
4/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Sore left arm
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Sprained ankle
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Vascular disorders
Stasis dermatitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Stiffness in the morning
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Stiffness of limbs
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Streptococcus tonsillitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Ear and labyrinth disorders
Sudden deafness
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Tarry stool
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Telogen alopecia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Tendinitis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Eye disorders
Terrien's marginal degeneration
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
Throbbing headache
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid node
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Nervous system disorders
Tingling sensation
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Tooth abscess
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Surgical and medical procedures
Tooth extraction
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Tooth sensitivity
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Injury, poisoning and procedural complications
Traffic accident
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Transaminitis
|
1.5%
8/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Injury, poisoning and procedural complications
Trauma injuries of limbs
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tubular colon adenoma
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Twisted and sprained feet
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Unspecified intestinal parasitosis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Upper respiratory infection
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
9/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Urinary tract infection by Escherichia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Renal and urinary disorders
Urination disorder
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Vaginal candidiasis
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Verruca vulgaris
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Ear and labyrinth disorders
Vertigo
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Viral gastroenteritis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Viral rash
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Viriasis
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Vomiting
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.74%
4/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Warts (viral)
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Weight gain
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Investigations
Weight loss
|
0.37%
2/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Gastrointestinal disorders
Worsening of crohn's disease
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Worsening of the disease
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Psychiatric disorders
Worsening of depression
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Skin and subcutaneous tissue disorders
Worsening of psoriasis
|
0.55%
3/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Infections and infestations
Wound infection
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Eye disorders
Xerophthalmia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
General disorders
Hypersensitivity at injection site
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Injury, poisoning and procedural complications
Traumatic injuries of the lumbosacral plexus
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Cardiac disorders
Bradycardia
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Musculoskeletal and connective tissue disorders
Broken meniscus
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.18%
1/542 • Adverse events were collected from start of study (Month 0) through month 24 following the start of treatment with adalimumab.
Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
|
Additional Information
Global Medical Information
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